Sitemap
Pages
- Analytical Services
- Antibody-Drug Conjugate Solutions
- Bioanalysis for Drug Development
- Blog
- CAR-T Testing Services
- Clinical Development
- Contact Us
- Digital Learning
- DMPK Services
- Drug-Drug Interaction
- Human Radiolabel-AME Studies
- In Vitro ADME
- Kinetic & Thermodynamic Solubility Testing
- Large Animal Pharmacokinetics
- Metabolic Stability Assays
- Metabolite Profiling and Identification
- Non-Clinical Mass Balance and Tissue Distribution
- Non-GLP Bioanalysis
- Plasma Protein Binding (PPB) Assays
- Radiolabeled In Vivo PK/ADME Studies
- Rodent Pharmacokinetics
- Events
- 19th WRIB 2025
- AAPS
- AAPS 2026
- ACT 2026
- ACT Annual Meeting
- BIO EU Fall
- DDI Marbach Workshop
- DDI Marbach Workshop 2026
- DMDG EU
- DMDG EU 2026
- EBF Open Symposium
- European ISSX 2026
- EUROTOX
- EUROTOX 2026
- ICT2025
- ISSX
- ISSX 2026
- Nordic Life Science Days
- SOT 64th Annual Meeting & ToxExpo
- SOT 65th Annual Meeting and ToxExpo
- Swiss Biotech Day
- TIDES Europe
- WRIB 2026
- Expert IND-enabling Testing
- Expert NDA-enabling Testing
- Extractables and Leachables Testing
- Global Facilities and Compliance
- Large Molecule Solutions
- Meet Our Experts
- mRNA Solutions
- New Homepage
- NEW Oligonucleotide
- Older Posters
- Peptide Testing Services
- Preclinical Development
- Preclinical Testing for New Modalities
- Privacy Policy
- Protein Degrader Solutions
- Safety Assessment Services
- Carcinogenicity Testing
- Carcinogenicity Testing Services
- Developmental & Reproductive Toxicology
- Dose Ranging & MTD Studies
- General Toxicology
- Genetic Toxicology
- In Vitro Toxicology
- Molecular Imaging Services
- Ophthalmology Services
- Pathology
- Preclinical Development of Biologics
- Preclinical Immunology Services
- Preclinical Pathology
- Repeat Dose Toxicity Testing
- Safety Pharmacology
- Single Dose Acute Toxicity Testing
- Standard for Exchange of Nonclinical Data (SEND)
- Vaccine Development
- Sitemap
- Small Molecule Solutions
- Talk to an Expert
- Terms of Use
- The Leadership Team
- Trade Articles
- Why WuXi AppTec
Product Categories
- Analytical Services
- Antibody-Drug Conjugate Solutions
- Bioanalysis for Drug Development
- Blog
- CAR-T Testing Services
- Clinical Development
- Contact Us
- Digital Learning
- DMPK Services
- Drug-Drug Interaction
- Human Radiolabel-AME Studies
- In Vitro ADME
- Kinetic & Thermodynamic Solubility Testing
- Large Animal Pharmacokinetics
- Metabolic Stability Assays
- Metabolite Profiling and Identification
- Non-Clinical Mass Balance and Tissue Distribution
- Non-GLP Bioanalysis
- Plasma Protein Binding (PPB) Assays
- Radiolabeled In Vivo PK/ADME Studies
- Rodent Pharmacokinetics
- Events
- 19th WRIB 2025
- AAPS
- AAPS 2026
- ACT 2026
- ACT Annual Meeting
- BIO EU Fall
- DDI Marbach Workshop
- DDI Marbach Workshop 2026
- DMDG EU
- DMDG EU 2026
- EBF Open Symposium
- European ISSX 2026
- EUROTOX
- EUROTOX 2026
- ICT2025
- ISSX
- ISSX 2026
- Nordic Life Science Days
- SOT 64th Annual Meeting & ToxExpo
- SOT 65th Annual Meeting and ToxExpo
- Swiss Biotech Day
- TIDES Europe
- WRIB 2026
- Expert IND-enabling Testing
- Expert NDA-enabling Testing
- Extractables and Leachables Testing
- Global Facilities and Compliance
- Large Molecule Solutions
- Meet Our Experts
- mRNA Solutions
- New Homepage
- NEW Oligonucleotide
- Older Posters
- Peptide Testing Services
- Preclinical Development
- Preclinical Testing for New Modalities
- Privacy Policy
- Protein Degrader Solutions
- Safety Assessment Services
- Carcinogenicity Testing
- Carcinogenicity Testing Services
- Developmental & Reproductive Toxicology
- Dose Ranging & MTD Studies
- General Toxicology
- Genetic Toxicology
- In Vitro Toxicology
- Molecular Imaging Services
- Ophthalmology Services
- Pathology
- Preclinical Development of Biologics
- Preclinical Immunology Services
- Preclinical Pathology
- Repeat Dose Toxicity Testing
- Safety Pharmacology
- Single Dose Acute Toxicity Testing
- Standard for Exchange of Nonclinical Data (SEND)
- Vaccine Development
- Sitemap
- Small Molecule Solutions
- Talk to an Expert
- Terms of Use
- The Leadership Team
- Trade Articles
- Why WuXi AppTec
- Category: COVID-19
- Ramp Up: What Drug Developers Need to Know
- Alliances for Innovation: Insight from Steve Yang
- Tracking Your Molecule: Technology Advancements in the Industry
- Partnerships that Prioritize the Customers
- Selecting a Testing Partner During a Pandemic
- Virtual Audits: You Can Now Qualify Testing Sites From Home
- Keeping Your Molecule’s Timeline on Track During COVID-19
- Through Partnership We Will Push Forward
- Category: Preclinical Safety
- Strategic Insights for Advancing PROTACs Toward IND Submission
- 4 Essential Safety Assessments to Consider for Peptide Preclinical Testing
- Early-Stage Considerations for PROTAC Development: From Design to Preclinical Readiness
- Early-Stage Considerations for Optimizing Respiratory Drug Development
- A Strategic Roadmap for Peptide Preclinical Studies: 3 Key Stages
- Five Ways to Ensure hERG Assays are Scientifically Reliable
- Clinical Analysis Strategies for Complement Biomarkers
- 4 Reasons Why Genetic Toxicology is Foundational to Modern Drug Development
- Five Keys to Success in Bispecific Antibody Development
- 6 Key Challenges in Oligonucleotide Development & Testing (And How to Overcome Them)
- How to Overcome 9 Key Peptide Drug Development Challenges
- 4 Analytical Methods Commonly Used in Oligonucleotide Preclinical Testing
- 3 Important DMPK Considerations for Successful Oligonucleotide Preclinical Testing
- The 4 Most Promising Therapeutic Applications for Peptide Drug Development
- Preclinical Drug Development Demystified: Your ADME to Toxicology Roadmap
- Five Pointers to Successfully Navigate the Challenges of Peptide Therapeutic Development
- Overcoming Challenges in Ocular Drug Testing with Advanced PK/PD Approaches
- What Is IVIVE? 7 FAQs About In Vitro-In Vivo Extrapolation
- Improving Bioanalytical Flexibility and Efficiency with Whole Blood Cryopreservation
- Four Essential Pointers to Navigate CNS Regulations and Safety Assessments
- Navigating the Complexities of Ocular Drug Delivery Systems
- WuXi AppTec Launches Research Book Decoding DMPK Frontiers for Novel Therapeutics
- DAR Research on ADCs Using LC-MS
- Transforming Drug Development: How Smart Compound Management Safeguards Integrity and Boosts Efficiency
- ICH M10: What the Finalized Guideline Means for Bioanalytical Scientists
- From Bottlenecks to Breakthroughs: 5 Ways Automation Transforms Toxicology Scheduling
- 3 Therapeutic Considerations for the Future of Oligonucleotide Development
- 6 Factors That Can Make or Break the mRNA Therapeutic Development
- What It Takes to Optimize Analytical Strategies for ADC Development
- Hybrid-ELISA in the Bioanalysis of Oligonucleotide Drugs
- Four Ways to Unlock the Potential of Antisense Oligonucleotides in Eye Care
- Five Ways LNP-mRNA is Shaping the Future of Medicine
- How Early Safety Pharmacology Studies Accelerate Drug Development and Reduce Risk
- Why Non-GLP Studies Matter in Preclinical Drug Development
- From Molecule to IND: A Strategic Roadmap Through Preclinical Studies
- Key Challenges in Oligonucleotide Bioanalysis—And How to Overcome Them
- What Is Large Molecule Preclinical Testing? Overview, Objectives, and Key Test Methods
- 6 Strategies to Overcome PROTACs’ Developmental Challenges
- The Future of Precision Medicine: How Bioanalysis is Transforming Personalized Healthcare
- Bioanalysis of ADC Drugs by LC-MS/MS
- 5 Tips to Navigating Antisense Oligonucleotide Drug Development
- Key Toxicology Considerations for Large-Molecule Therapies
- Overcoming the challenges of preclinical evaluations for PROTACs
- Bioanalytical Strategies for Fusion Proteins
- What Is Small Molecule Preclinical Testing? Overview, Objectives, and Key Test Methods
- Making the Most of the Golden Age of Small-Molecule Oncology Drugs
- Evaluation of Immunogenicity for Oligonucleotide Drugs
- LCMS Preclinical Bioanalysis of LNPs in Advanced Therapy Drugs
- 3 DMPK Strategies for ADC Drugs
- Bioanalytical Strategies for Evaluating Immunogenicity in Next-Generation AAV Therapies
- Advancing Oligonucleotide Drug Development with Ligand Binding Assays in the Preclinical Stage
- Bioanalysis of GLP-1 Antagonist Drugs by Multiple Analytical Platforms
- Overcoming nonspecific binding challenges in PK assays
- Bioanalytical Strategies for Peptide-Drug Conjugates (PDCs): Optimized Approaches for the Pharmaceutical Industry
- Validating Flow Cytometry-Based Micronucleus Assays in Alternative Species
- How to Evaluate the Preclinical Safety of Oligonucleotide Drugs
- Understanding the Sensitivity and Accuracy of FOB Tests for CNS and non-CNS Targeted Compounds
- Ensuring Multi-Ion Channel Inhibition Assays are Accurate and Reliable
- Unlocking Drug Insights with Cutting-Edge Molecular Imaging Solutions
- Small vs. Large Molecule Bioanalysis: 7 Key Differences
- When to Start Subchronic & Chronic Toxicology Studies
- Clinical Bioanalysis Strategy for Antibody Drug Conjugates (ADCs)
- Biological Significance and Bioanalytical Strategies of Biomarkers – Complement Detection
- Why are GLP Toxicology Studies Important?
- Designing Juvenile Toxicology Studies: Key Considerations for Drug Development
- How Radionuclide Drug Conjugates are Transforming Cancer Treatment
- 5 Ways You Can Automate Preclinical Bioanalysis
- Targeting the Untargetable: How Oligonucleotide Drugs Address Undruggable Proteins
- The Advantages of LC-MS/MS in Optimizing ADC Bioassays
- The Essential Role of Biomarkers in Modern Medicine: From Disease Diagnosis to Treatment Optimization
- Application of Protein Biomarkers in Pharmaceutical Research and Bioanalysis Strategies
- Why Communication is Essential to Non-clinical Testing
- The Vital Role of Toxicity Studies in New Drug Development
- IND Studies: Understanding Early-Stage Regulatory Needs
- Unlocking the Potential: Navigating Non-Clinical Programs for Biotherapeutics
- Everything Drug Developers Need to Know to Prepare for IND Submissions
- Key Components of IND Study Strategy Planning
- A Step-By-Step Guide to Successful IND Studies
- Finding the Best Lab Partner for your IND Submission
- A Step Forward in Oligo Therapy: A New Assay for Testing Oligo Stability in Plasma
- Application of qPCR Technology in the Bioanalysis of Oligonucleotide Drugs
- 3 Benefits of In Vitro ADME Testing Automation
- Innovative Bioanalytical Strategies for Oligonucleotide Therapeutics: A New Frontier in American Drug Development
- 6 Types of Toxicology Studies for IND & NDA Programs
- Bridging Cultures, Breaking Barriers: WuXi AppTec Women Leading the Way in Drug Development
- Innovations in Drug Development: The Increased Utility of In Vitro Testing
- SOT’s 2024 Annual Meeting: Showcasing Scientific Advancement & Celebrating Milestones
- Is Your Drug Ready for Preclinical Toxicological Testing?
- What Toxicity Data Is Needed Before First-In-Human (FIH) Trials?
- Striking the Right Balance: Linker Design in ADC Cancer Therapies
- ELISpot Assays: The Key to Unlocking Advanced Cellular Immunity Testing
- The Crucial Role of Biomarkers in the Precision Medicine Revolution
- Acute Toxicity Studies: 3 Best Practices to Stay on Track with Your IND Timeline
- 3 Common Missteps in Nonclinical Safety Assessment Testing
- What Is IND-Enabling Testing & What Does It Include?
- Oligonucleotide Development: History, Pain Points & Bioanalytical Considerations
- Basic Questions Developers Are Asking About In Vitro-In Vivo Extrapolation
- Good Communication Essential To Successful Preclinical Testing
- Understanding Differences in Regulatory Requirements Vital to Efficient Design of Preclinical Programs
- PROTACs and Their Role in Catalyzing Health Solutions
- An Important First Step in the Design of a Preclinical Program
- Pathologists Can Move Your Drug Development Program Forward
- WuXi AppTec Grows Biomarker Capabilities with Quanterix
- 5 Questions When Planning a Nonclinical Toxicology Program for Biotherapeutics
- You’ve Got Molecules, We’ve Got Solutions
- Partner Up – A Nonclinical Talk with Toxicology Consultant, Grace Furman
- Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development
- Internal Standard Variation Case Studies: A Look into the Latest Whitepaper
- Regulatory Pathways: IND Requirement Variations Between U.S. FDA, OECD and NMPA
- Ensure a Successful Clinical Translation with DMPK Strategies
- Transitioning to Phase I Clinical Trials
- Dual Filing your IND Package: Planning Pays Off
- New U.S. FDA DDI Draft Guidance for Therapeutic Proteins
- ACT Annual Meeting: Managing Roadblocks to Success
- In Vivo PK/ADME Studies — Positioning, Planning and Best Practices
- Immunoaffinity Purification using LC-MS/MS: Comparing Two Methods
- Webinar: Practical Implications of Recent Changes to Immunogenicity Risk Assessment
- Providing Support for Drug Discovery and Non-GLP Bioanalysis
- What You Need To Know Planning for an IND Submission
- Category: Preclinical Testing
- GLP vs. Non-GLP toxicology studies: When to use which guidelines?
- Navigating the Path from IND to NDA
- Rapid EMSA: A New Method of Testing PPB in Oligonucleotides
- Drug Solubility Testing: 4 Ways It Helps Drug Discovery & Development
- Oligos for Ocular Diseases: Overcoming the Challenges
- 7 Most Common Bioanalytical Testing Platforms for Small and Large Molecule Bioanalysis
- Flux Dialysis: A Cutting-Edge Tool for PPB Studies & Understanding DDI
- Metabolic Stability in Drug Development: 5 Assays
- Repeat Dose Toxicity: 3 Possible Timeframes for Your IND-Enabling Studies
- 3 Must-Have Qualities of a Bioanalytical Method Development & Validation Partner
- From screening to IND submission: Biomarker analysis in preclinical drug development
- Early ADME Screening: 3 Ways It Boosts IND Submission Success
- What Are Metabolite Profiling & Identification Studies?
- Drug-Drug Interaction: An Overview of Substrates and Metabolizing Enzymes
- The Inherent Challenges of Antibody-Drug Conjugate (ADC) Bioanalysis
- 4 Critical In Vitro Genotoxicity Assays for Preclinical Drug Development
- Reproductive Toxicology & the EPA’s Tiered Testing System
- 5 Critical Nonclinical Toxicology Studies Required for IND Submission
- 6 Essential Qualities in a Drug Safety Assessment Testing Partner
- Preparing Drug Developers for Developmental and Reproductive (DART) Studies
- WuXi AppTec Expands Toxicology Footprint, Capabilities with New Chengdu Facility
- Q&A: How Preclinical Toxicology Contributes to Successful IND Applications
- The Vital Role Of Toxicity Studies In Evaluating New Drugs
- The Complex Process of Developing a Living Protocol
- How Bioanalytical Laboratory Automation Improves Timelines and Accuracy
- Testing Toxicity to Advance to Phase I Clinical Trials
- Managing Critical Reagents: An Essential Part of Your Bioanalytical Strategy
- Information Exchange is Essential Prior to Designing Preclinical Drug Development Programs
- Understanding New Modalities: Oligonucleotides and Bispecific Antibodies
- Grand Opening of New R&D Center in China
- ICH M10: Preview New Bioanalytical Method Validation Guidance
- How DMPK Lead Optimization Mitigates Risk and Conserves Resources
- WuXi AppTec & Quanterix Simoa Joint Lab Opening Ceremony
- Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites
- Virtual Tours Available Today
- Category: Regulatory
- Dose Range-Finding Studies for Safety Assessment: 3 Reasons Not to Skip Them
- 4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing
- A New Method to Improve Identification of the Payload-Containing Catabolites of ADCs
- Improving PROTAC Drugs with MetID Studies
- Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways
- U.S. FDA Updates to Guidance on Managing Drug-Drug Interactions
- Category: Regulatory Expertise
- Category: Technical Expertise
- Toxicology Studies in Drug Development: What Programs Often Underestimate
- Acute Toxicity Studies: Best Practices for First-In-Human Readiness
- Maximum Tolerated Dose (MTD): How Dose-Range Finding Drives IND Success
- What Is MTD in Drug Development, and Why It’s More Than a Number
- The Bioanalytical Challenges of In Vivo CAR-T Therapy Development
- How to Address Metabolite Identification Challenges in Advanced Peptide Therapeutics
- EU New Drug Applications: 5 Tips to Prepare for Scientific Advice Requests
- Peptide Development: A Tiered DMPK Approach to Bridge Discovery and IND-enabling Studies
- Three Tips for Addressing the Complex Toxicity of ADCs
- NAMs: Defined Approaches for Skin Sensitization Studies
- A New Oligo Playbook: Building a Tailored, Risk-Based Strategy to a Successful IND
- Why Half-Life Extension Isn’t Enough: A 4-Step ADME Strategy for Peptide IND Readiness
- IND-Enabling Studies: How to Integrate ADME, Bioanalysis, and Tox for a Successful IND
- IND Application Essentials: What Data Regulators Actually Scrutinize
- From IND to Clinic: Lab Testing Milestones in Early Clinical Trials
- IND Submission Strategy: Common Gaps That Delay First-in-Human Studies
- AOCs Explained: Delivery, DMPK, and the Future of Antibody Oligonucleotide Conjugates
- Oncolytic Virus Therapies: Key Considerations for Clinical Bioanalysis
- Alzheimer’s Disease Biomarkers: Toward More Precise Testing
- In Vitro ADME Testing: When It’s Enough – and When It’s Not
- Why Metabolite Identification Is a Regulatory Decision Point, Not Just a DMPK Exercise
- PK Study Design: Avoiding Rework in Early Pharmacokinetics
- How to Validate Whole Slide Imaging for Toxicological Pathology
- Moving From GLP-1 to Multi-Target Metabolic Medicines
- Five Ways PROTACs Break From ADME Norms
- Beyond Single-Marker Pathology: How Highly Multiplex Fluorescence Imaging Is Expanding Translational Research
- ELISA v LC-MS/MS: Preclinical Bioanalysis Platforms for ADCs in Focus
- How Biomarker Testing Services Support Precision Medicine Programs
- Preclinical vs. Clinical Biomarkers: Differences That Matter
- Biomarker Assays in Drug Development: Choosing the Right Platform
- Biomarker Assays: Designing Assays That Scale from Preclinical to Clinic
- Beyond Targeting: How ADC Payloads Drive Toxicity and IND Risk
- Bioanalytical Method Development and Validation: What IND Sponsors Need to Know
- What Is Bioanalytical Method Validation? A Guide to Regulatory Expectations
- How Bioanalytical Laboratory Services Reduce Risk in Preclinical Programs
- 7 Common Bioanalytical Services Pitfalls That Delay IND Timelines
- Four Tips to Optimize Transdermal Drug Delivery
- Five Tips for Toxicology and Emerging Modalities | WuXi AppTec
- NAMs in Focus: The Evolution of Skin Irritation and Corrosion Testing Based on Reconstructed Human Epidermis Models
- Key Safety Considerations During Oligonucleotide Development
- De-Risk Your IND and NDA: Avoid These 5 DART Pitfalls
- Peptide Drug Conjugates: Analytical and PK Considerations
- Antibody Drug Conjugate Services: Overcoming Bioanalysis Challenges
- PROTAC Services: Navigating DMPK and Bioanalytical Complexities
- mRNA Analytical Services: What Makes Testing Fit-for-Purpose
- Three Strategies to Address Development Challenges for Next-Generation Peptide Therapeutics
- Better In Vivo Model Welfare, Better Data: A Preclinical Playbook
- Four Tips to Help Unlock Oligonucleotide Therapies for the Central Nervous System
- ADCs and Ocular Toxicity: Mechanisms and Management
- Six Ways Developers Can Address Ocular Safety in ADCs
- Five Tips to Tackle the Bioanalytical and PK Challenges of ADC Development
- Advancing Preclinical Bioanalytical Strategies for GLP-1 Receptor Agonists
- A New Playbook: 5 Ways to Improve Safety & Decision-Making With In Vitro Toxicology
- IND-Ready Immunotoxicity: Four Decisions to Prevent Late Surprises
- 2 Analytical Platforms for Peptide Preclinical Testing: LC-MS & ELISA
- 3 Important DMPK Considerations for Successful Peptide Preclinical Testing
- Advancing Preclinical Bioanalytical Strategies for Today’s Diverse Vaccine Platforms
- WuXi AppTec Launches R&D Center for Large Animal PK & Non-GLP Bioanalytical Research Services
- Revolutionizing Plasma Protein Binding Determination with Echo® MS
- Decoding Complex Metabolite Related Drug-Drug Interactions
- Drug-Drug Interaction: An Overview of Inhibitors
- The Many DMPK Challenges of Cancer Treatment ADCs
- What Is Bioanalytical Testing & Method Validation?
- QWBA and Mass Balance Studies
- How to Improve PROTACs’ Oral Bioavailability
- How to Tackle the Developmental Challenges of PROTAC Drugs
- A Guide to In Vitro ADME Testing in Drug Development
- Simoa Joint Laboratory Delivering Greater Speed, Sensitivity and Customization in Biomarker Validation
- Join WuXi AppTec at the 2021 American Association of Pharmaceutical Scientists PharmSci 360
- Join WuXi AppTec at the 42nd American College of Toxicology Annual Meeting
Products
- Analytical Services
- Antibody-Drug Conjugate Solutions
- Bioanalysis for Drug Development
- Blog
- CAR-T Testing Services
- Clinical Development
- Contact Us
- Digital Learning
- DMPK Services
- Drug-Drug Interaction
- Human Radiolabel-AME Studies
- In Vitro ADME
- Kinetic & Thermodynamic Solubility Testing
- Large Animal Pharmacokinetics
- Metabolic Stability Assays
- Metabolite Profiling and Identification
- Non-Clinical Mass Balance and Tissue Distribution
- Non-GLP Bioanalysis
- Plasma Protein Binding (PPB) Assays
- Radiolabeled In Vivo PK/ADME Studies
- Rodent Pharmacokinetics
- Events
- 19th WRIB 2025
- AAPS
- AAPS 2026
- ACT 2026
- ACT Annual Meeting
- BIO EU Fall
- DDI Marbach Workshop
- DDI Marbach Workshop 2026
- DMDG EU
- DMDG EU 2026
- EBF Open Symposium
- European ISSX 2026
- EUROTOX
- EUROTOX 2026
- ICT2025
- ISSX
- ISSX 2026
- Nordic Life Science Days
- SOT 64th Annual Meeting & ToxExpo
- SOT 65th Annual Meeting and ToxExpo
- Swiss Biotech Day
- TIDES Europe
- WRIB 2026
- Expert IND-enabling Testing
- Expert NDA-enabling Testing
- Extractables and Leachables Testing
- Global Facilities and Compliance
- Large Molecule Solutions
- Meet Our Experts
- mRNA Solutions
- New Homepage
- NEW Oligonucleotide
- Older Posters
- Peptide Testing Services
- Preclinical Development
- Preclinical Testing for New Modalities
- Privacy Policy
- Protein Degrader Solutions
- Safety Assessment Services
- Carcinogenicity Testing
- Carcinogenicity Testing Services
- Developmental & Reproductive Toxicology
- Dose Ranging & MTD Studies
- General Toxicology
- Genetic Toxicology
- In Vitro Toxicology
- Molecular Imaging Services
- Ophthalmology Services
- Pathology
- Preclinical Development of Biologics
- Preclinical Immunology Services
- Preclinical Pathology
- Repeat Dose Toxicity Testing
- Safety Pharmacology
- Single Dose Acute Toxicity Testing
- Standard for Exchange of Nonclinical Data (SEND)
- Vaccine Development
- Sitemap
- Small Molecule Solutions
- Talk to an Expert
- Terms of Use
- The Leadership Team
- Trade Articles
- Why WuXi AppTec
- Category: COVID-19
- Ramp Up: What Drug Developers Need to Know
- Alliances for Innovation: Insight from Steve Yang
- Tracking Your Molecule: Technology Advancements in the Industry
- Partnerships that Prioritize the Customers
- Selecting a Testing Partner During a Pandemic
- Virtual Audits: You Can Now Qualify Testing Sites From Home
- Keeping Your Molecule’s Timeline on Track During COVID-19
- Through Partnership We Will Push Forward
- Category: Preclinical Safety
- Strategic Insights for Advancing PROTACs Toward IND Submission
- 4 Essential Safety Assessments to Consider for Peptide Preclinical Testing
- Early-Stage Considerations for PROTAC Development: From Design to Preclinical Readiness
- Early-Stage Considerations for Optimizing Respiratory Drug Development
- A Strategic Roadmap for Peptide Preclinical Studies: 3 Key Stages
- Five Ways to Ensure hERG Assays are Scientifically Reliable
- Clinical Analysis Strategies for Complement Biomarkers
- 4 Reasons Why Genetic Toxicology is Foundational to Modern Drug Development
- Five Keys to Success in Bispecific Antibody Development
- 6 Key Challenges in Oligonucleotide Development & Testing (And How to Overcome Them)
- How to Overcome 9 Key Peptide Drug Development Challenges
- 4 Analytical Methods Commonly Used in Oligonucleotide Preclinical Testing
- 3 Important DMPK Considerations for Successful Oligonucleotide Preclinical Testing
- The 4 Most Promising Therapeutic Applications for Peptide Drug Development
- Preclinical Drug Development Demystified: Your ADME to Toxicology Roadmap
- Five Pointers to Successfully Navigate the Challenges of Peptide Therapeutic Development
- Overcoming Challenges in Ocular Drug Testing with Advanced PK/PD Approaches
- What Is IVIVE? 7 FAQs About In Vitro-In Vivo Extrapolation
- Improving Bioanalytical Flexibility and Efficiency with Whole Blood Cryopreservation
- Four Essential Pointers to Navigate CNS Regulations and Safety Assessments
- Navigating the Complexities of Ocular Drug Delivery Systems
- WuXi AppTec Launches Research Book Decoding DMPK Frontiers for Novel Therapeutics
- DAR Research on ADCs Using LC-MS
- Transforming Drug Development: How Smart Compound Management Safeguards Integrity and Boosts Efficiency
- ICH M10: What the Finalized Guideline Means for Bioanalytical Scientists
- From Bottlenecks to Breakthroughs: 5 Ways Automation Transforms Toxicology Scheduling
- 3 Therapeutic Considerations for the Future of Oligonucleotide Development
- 6 Factors That Can Make or Break the mRNA Therapeutic Development
- What It Takes to Optimize Analytical Strategies for ADC Development
- Hybrid-ELISA in the Bioanalysis of Oligonucleotide Drugs
- Four Ways to Unlock the Potential of Antisense Oligonucleotides in Eye Care
- Five Ways LNP-mRNA is Shaping the Future of Medicine
- How Early Safety Pharmacology Studies Accelerate Drug Development and Reduce Risk
- Why Non-GLP Studies Matter in Preclinical Drug Development
- From Molecule to IND: A Strategic Roadmap Through Preclinical Studies
- Key Challenges in Oligonucleotide Bioanalysis—And How to Overcome Them
- What Is Large Molecule Preclinical Testing? Overview, Objectives, and Key Test Methods
- 6 Strategies to Overcome PROTACs’ Developmental Challenges
- The Future of Precision Medicine: How Bioanalysis is Transforming Personalized Healthcare
- Bioanalysis of ADC Drugs by LC-MS/MS
- 5 Tips to Navigating Antisense Oligonucleotide Drug Development
- Key Toxicology Considerations for Large-Molecule Therapies
- Overcoming the challenges of preclinical evaluations for PROTACs
- Bioanalytical Strategies for Fusion Proteins
- What Is Small Molecule Preclinical Testing? Overview, Objectives, and Key Test Methods
- Making the Most of the Golden Age of Small-Molecule Oncology Drugs
- Evaluation of Immunogenicity for Oligonucleotide Drugs
- LCMS Preclinical Bioanalysis of LNPs in Advanced Therapy Drugs
- 3 DMPK Strategies for ADC Drugs
- Bioanalytical Strategies for Evaluating Immunogenicity in Next-Generation AAV Therapies
- Advancing Oligonucleotide Drug Development with Ligand Binding Assays in the Preclinical Stage
- Bioanalysis of GLP-1 Antagonist Drugs by Multiple Analytical Platforms
- Overcoming nonspecific binding challenges in PK assays
- Bioanalytical Strategies for Peptide-Drug Conjugates (PDCs): Optimized Approaches for the Pharmaceutical Industry
- Validating Flow Cytometry-Based Micronucleus Assays in Alternative Species
- How to Evaluate the Preclinical Safety of Oligonucleotide Drugs
- Understanding the Sensitivity and Accuracy of FOB Tests for CNS and non-CNS Targeted Compounds
- Ensuring Multi-Ion Channel Inhibition Assays are Accurate and Reliable
- Unlocking Drug Insights with Cutting-Edge Molecular Imaging Solutions
- Small vs. Large Molecule Bioanalysis: 7 Key Differences
- When to Start Subchronic & Chronic Toxicology Studies
- Clinical Bioanalysis Strategy for Antibody Drug Conjugates (ADCs)
- Biological Significance and Bioanalytical Strategies of Biomarkers – Complement Detection
- Why are GLP Toxicology Studies Important?
- Designing Juvenile Toxicology Studies: Key Considerations for Drug Development
- How Radionuclide Drug Conjugates are Transforming Cancer Treatment
- 5 Ways You Can Automate Preclinical Bioanalysis
- Targeting the Untargetable: How Oligonucleotide Drugs Address Undruggable Proteins
- The Advantages of LC-MS/MS in Optimizing ADC Bioassays
- The Essential Role of Biomarkers in Modern Medicine: From Disease Diagnosis to Treatment Optimization
- Application of Protein Biomarkers in Pharmaceutical Research and Bioanalysis Strategies
- Why Communication is Essential to Non-clinical Testing
- The Vital Role of Toxicity Studies in New Drug Development
- IND Studies: Understanding Early-Stage Regulatory Needs
- Unlocking the Potential: Navigating Non-Clinical Programs for Biotherapeutics
- Everything Drug Developers Need to Know to Prepare for IND Submissions
- Key Components of IND Study Strategy Planning
- A Step-By-Step Guide to Successful IND Studies
- Finding the Best Lab Partner for your IND Submission
- A Step Forward in Oligo Therapy: A New Assay for Testing Oligo Stability in Plasma
- Application of qPCR Technology in the Bioanalysis of Oligonucleotide Drugs
- 3 Benefits of In Vitro ADME Testing Automation
- Innovative Bioanalytical Strategies for Oligonucleotide Therapeutics: A New Frontier in American Drug Development
- 6 Types of Toxicology Studies for IND & NDA Programs
- Bridging Cultures, Breaking Barriers: WuXi AppTec Women Leading the Way in Drug Development
- Innovations in Drug Development: The Increased Utility of In Vitro Testing
- SOT’s 2024 Annual Meeting: Showcasing Scientific Advancement & Celebrating Milestones
- Is Your Drug Ready for Preclinical Toxicological Testing?
- What Toxicity Data Is Needed Before First-In-Human (FIH) Trials?
- Striking the Right Balance: Linker Design in ADC Cancer Therapies
- ELISpot Assays: The Key to Unlocking Advanced Cellular Immunity Testing
- The Crucial Role of Biomarkers in the Precision Medicine Revolution
- Acute Toxicity Studies: 3 Best Practices to Stay on Track with Your IND Timeline
- 3 Common Missteps in Nonclinical Safety Assessment Testing
- What Is IND-Enabling Testing & What Does It Include?
- Oligonucleotide Development: History, Pain Points & Bioanalytical Considerations
- Basic Questions Developers Are Asking About In Vitro-In Vivo Extrapolation
- Good Communication Essential To Successful Preclinical Testing
- Understanding Differences in Regulatory Requirements Vital to Efficient Design of Preclinical Programs
- PROTACs and Their Role in Catalyzing Health Solutions
- An Important First Step in the Design of a Preclinical Program
- Pathologists Can Move Your Drug Development Program Forward
- WuXi AppTec Grows Biomarker Capabilities with Quanterix
- 5 Questions When Planning a Nonclinical Toxicology Program for Biotherapeutics
- You’ve Got Molecules, We’ve Got Solutions
- Partner Up – A Nonclinical Talk with Toxicology Consultant, Grace Furman
- Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development
- Internal Standard Variation Case Studies: A Look into the Latest Whitepaper
- Regulatory Pathways: IND Requirement Variations Between U.S. FDA, OECD and NMPA
- Ensure a Successful Clinical Translation with DMPK Strategies
- Transitioning to Phase I Clinical Trials
- Dual Filing your IND Package: Planning Pays Off
- New U.S. FDA DDI Draft Guidance for Therapeutic Proteins
- ACT Annual Meeting: Managing Roadblocks to Success
- In Vivo PK/ADME Studies — Positioning, Planning and Best Practices
- Immunoaffinity Purification using LC-MS/MS: Comparing Two Methods
- Webinar: Practical Implications of Recent Changes to Immunogenicity Risk Assessment
- Providing Support for Drug Discovery and Non-GLP Bioanalysis
- What You Need To Know Planning for an IND Submission
- Category: Preclinical Testing
- GLP vs. Non-GLP toxicology studies: When to use which guidelines?
- Navigating the Path from IND to NDA
- Rapid EMSA: A New Method of Testing PPB in Oligonucleotides
- Drug Solubility Testing: 4 Ways It Helps Drug Discovery & Development
- Oligos for Ocular Diseases: Overcoming the Challenges
- 7 Most Common Bioanalytical Testing Platforms for Small and Large Molecule Bioanalysis
- Flux Dialysis: A Cutting-Edge Tool for PPB Studies & Understanding DDI
- Metabolic Stability in Drug Development: 5 Assays
- Repeat Dose Toxicity: 3 Possible Timeframes for Your IND-Enabling Studies
- 3 Must-Have Qualities of a Bioanalytical Method Development & Validation Partner
- From screening to IND submission: Biomarker analysis in preclinical drug development
- Early ADME Screening: 3 Ways It Boosts IND Submission Success
- What Are Metabolite Profiling & Identification Studies?
- Drug-Drug Interaction: An Overview of Substrates and Metabolizing Enzymes
- The Inherent Challenges of Antibody-Drug Conjugate (ADC) Bioanalysis
- 4 Critical In Vitro Genotoxicity Assays for Preclinical Drug Development
- Reproductive Toxicology & the EPA’s Tiered Testing System
- 5 Critical Nonclinical Toxicology Studies Required for IND Submission
- 6 Essential Qualities in a Drug Safety Assessment Testing Partner
- Preparing Drug Developers for Developmental and Reproductive (DART) Studies
- WuXi AppTec Expands Toxicology Footprint, Capabilities with New Chengdu Facility
- Q&A: How Preclinical Toxicology Contributes to Successful IND Applications
- The Vital Role Of Toxicity Studies In Evaluating New Drugs
- The Complex Process of Developing a Living Protocol
- How Bioanalytical Laboratory Automation Improves Timelines and Accuracy
- Testing Toxicity to Advance to Phase I Clinical Trials
- Managing Critical Reagents: An Essential Part of Your Bioanalytical Strategy
- Information Exchange is Essential Prior to Designing Preclinical Drug Development Programs
- Understanding New Modalities: Oligonucleotides and Bispecific Antibodies
- Grand Opening of New R&D Center in China
- ICH M10: Preview New Bioanalytical Method Validation Guidance
- How DMPK Lead Optimization Mitigates Risk and Conserves Resources
- WuXi AppTec & Quanterix Simoa Joint Lab Opening Ceremony
- Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites
- Virtual Tours Available Today
- Category: Regulatory
- Dose Range-Finding Studies for Safety Assessment: 3 Reasons Not to Skip Them
- 4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing
- A New Method to Improve Identification of the Payload-Containing Catabolites of ADCs
- Improving PROTAC Drugs with MetID Studies
- Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways
- U.S. FDA Updates to Guidance on Managing Drug-Drug Interactions
- Category: Regulatory Expertise
- Category: Technical Expertise
- Toxicology Studies in Drug Development: What Programs Often Underestimate
- Acute Toxicity Studies: Best Practices for First-In-Human Readiness
- Maximum Tolerated Dose (MTD): How Dose-Range Finding Drives IND Success
- What Is MTD in Drug Development, and Why It’s More Than a Number
- The Bioanalytical Challenges of In Vivo CAR-T Therapy Development
- How to Address Metabolite Identification Challenges in Advanced Peptide Therapeutics
- EU New Drug Applications: 5 Tips to Prepare for Scientific Advice Requests
- Peptide Development: A Tiered DMPK Approach to Bridge Discovery and IND-enabling Studies
- Three Tips for Addressing the Complex Toxicity of ADCs
- NAMs: Defined Approaches for Skin Sensitization Studies
- A New Oligo Playbook: Building a Tailored, Risk-Based Strategy to a Successful IND
- Why Half-Life Extension Isn’t Enough: A 4-Step ADME Strategy for Peptide IND Readiness
- IND-Enabling Studies: How to Integrate ADME, Bioanalysis, and Tox for a Successful IND
- IND Application Essentials: What Data Regulators Actually Scrutinize
- From IND to Clinic: Lab Testing Milestones in Early Clinical Trials
- IND Submission Strategy: Common Gaps That Delay First-in-Human Studies
- AOCs Explained: Delivery, DMPK, and the Future of Antibody Oligonucleotide Conjugates
- Oncolytic Virus Therapies: Key Considerations for Clinical Bioanalysis
- Alzheimer’s Disease Biomarkers: Toward More Precise Testing
- In Vitro ADME Testing: When It’s Enough – and When It’s Not
- Why Metabolite Identification Is a Regulatory Decision Point, Not Just a DMPK Exercise
- PK Study Design: Avoiding Rework in Early Pharmacokinetics
- How to Validate Whole Slide Imaging for Toxicological Pathology
- Moving From GLP-1 to Multi-Target Metabolic Medicines
- Five Ways PROTACs Break From ADME Norms
- Beyond Single-Marker Pathology: How Highly Multiplex Fluorescence Imaging Is Expanding Translational Research
- ELISA v LC-MS/MS: Preclinical Bioanalysis Platforms for ADCs in Focus
- How Biomarker Testing Services Support Precision Medicine Programs
- Preclinical vs. Clinical Biomarkers: Differences That Matter
- Biomarker Assays in Drug Development: Choosing the Right Platform
- Biomarker Assays: Designing Assays That Scale from Preclinical to Clinic
- Beyond Targeting: How ADC Payloads Drive Toxicity and IND Risk
- Bioanalytical Method Development and Validation: What IND Sponsors Need to Know
- What Is Bioanalytical Method Validation? A Guide to Regulatory Expectations
- How Bioanalytical Laboratory Services Reduce Risk in Preclinical Programs
- 7 Common Bioanalytical Services Pitfalls That Delay IND Timelines
- Four Tips to Optimize Transdermal Drug Delivery
- Five Tips for Toxicology and Emerging Modalities | WuXi AppTec
- NAMs in Focus: The Evolution of Skin Irritation and Corrosion Testing Based on Reconstructed Human Epidermis Models
- Key Safety Considerations During Oligonucleotide Development
- De-Risk Your IND and NDA: Avoid These 5 DART Pitfalls
- Peptide Drug Conjugates: Analytical and PK Considerations
- Antibody Drug Conjugate Services: Overcoming Bioanalysis Challenges
- PROTAC Services: Navigating DMPK and Bioanalytical Complexities
- mRNA Analytical Services: What Makes Testing Fit-for-Purpose
- Three Strategies to Address Development Challenges for Next-Generation Peptide Therapeutics
- Better In Vivo Model Welfare, Better Data: A Preclinical Playbook
- Four Tips to Help Unlock Oligonucleotide Therapies for the Central Nervous System
- ADCs and Ocular Toxicity: Mechanisms and Management
- Six Ways Developers Can Address Ocular Safety in ADCs
- Five Tips to Tackle the Bioanalytical and PK Challenges of ADC Development
- Advancing Preclinical Bioanalytical Strategies for GLP-1 Receptor Agonists
- A New Playbook: 5 Ways to Improve Safety & Decision-Making With In Vitro Toxicology
- IND-Ready Immunotoxicity: Four Decisions to Prevent Late Surprises
- 2 Analytical Platforms for Peptide Preclinical Testing: LC-MS & ELISA
- 3 Important DMPK Considerations for Successful Peptide Preclinical Testing
- Advancing Preclinical Bioanalytical Strategies for Today’s Diverse Vaccine Platforms
- WuXi AppTec Launches R&D Center for Large Animal PK & Non-GLP Bioanalytical Research Services
- Revolutionizing Plasma Protein Binding Determination with Echo® MS
- Decoding Complex Metabolite Related Drug-Drug Interactions
- Drug-Drug Interaction: An Overview of Inhibitors
- The Many DMPK Challenges of Cancer Treatment ADCs
- What Is Bioanalytical Testing & Method Validation?
- QWBA and Mass Balance Studies
- How to Improve PROTACs’ Oral Bioavailability
- How to Tackle the Developmental Challenges of PROTAC Drugs
- A Guide to In Vitro ADME Testing in Drug Development
- Simoa Joint Laboratory Delivering Greater Speed, Sensitivity and Customization in Biomarker Validation
- Join WuXi AppTec at the 2021 American Association of Pharmaceutical Scientists PharmSci 360
- Join WuXi AppTec at the 42nd American College of Toxicology Annual Meeting
Posts by Category
- COVID-19
- Ramp Up: What Drug Developers Need to Know
- Alliances for Innovation: Insight from Steve Yang
- Tracking Your Molecule: Technology Advancements in the Industry
- Partnerships that Prioritize the Customers
- Selecting a Testing Partner During a Pandemic
- Virtual Audits: You Can Now Qualify Testing Sites From Home
- Keeping Your Molecule’s Timeline on Track During COVID-19
- Through Partnership We Will Push Forward
- Preclinical Safety
- Strategic Insights for Advancing PROTACs Toward IND Submission
- 4 Essential Safety Assessments to Consider for Peptide Preclinical Testing
- Early-Stage Considerations for PROTAC Development: From Design to Preclinical Readiness
- Early-Stage Considerations for Optimizing Respiratory Drug Development
- A Strategic Roadmap for Peptide Preclinical Studies: 3 Key Stages
- Five Ways to Ensure hERG Assays are Scientifically Reliable
- Clinical Analysis Strategies for Complement Biomarkers
- 4 Reasons Why Genetic Toxicology is Foundational to Modern Drug Development
- Five Keys to Success in Bispecific Antibody Development
- 6 Key Challenges in Oligonucleotide Development & Testing (And How to Overcome Them)
- How to Overcome 9 Key Peptide Drug Development Challenges
- 4 Analytical Methods Commonly Used in Oligonucleotide Preclinical Testing
- 3 Important DMPK Considerations for Successful Oligonucleotide Preclinical Testing
- The 4 Most Promising Therapeutic Applications for Peptide Drug Development
- Preclinical Drug Development Demystified: Your ADME to Toxicology Roadmap
- Five Pointers to Successfully Navigate the Challenges of Peptide Therapeutic Development
- Overcoming Challenges in Ocular Drug Testing with Advanced PK/PD Approaches
- What Is IVIVE? 7 FAQs About In Vitro-In Vivo Extrapolation
- Improving Bioanalytical Flexibility and Efficiency with Whole Blood Cryopreservation
- Four Essential Pointers to Navigate CNS Regulations and Safety Assessments
- Navigating the Complexities of Ocular Drug Delivery Systems
- WuXi AppTec Launches Research Book Decoding DMPK Frontiers for Novel Therapeutics
- DAR Research on ADCs Using LC-MS
- Transforming Drug Development: How Smart Compound Management Safeguards Integrity and Boosts Efficiency
- ICH M10: What the Finalized Guideline Means for Bioanalytical Scientists
- From Bottlenecks to Breakthroughs: 5 Ways Automation Transforms Toxicology Scheduling
- 3 Therapeutic Considerations for the Future of Oligonucleotide Development
- 6 Factors That Can Make or Break the mRNA Therapeutic Development
- What It Takes to Optimize Analytical Strategies for ADC Development
- Hybrid-ELISA in the Bioanalysis of Oligonucleotide Drugs
- Four Ways to Unlock the Potential of Antisense Oligonucleotides in Eye Care
- Five Ways LNP-mRNA is Shaping the Future of Medicine
- How Early Safety Pharmacology Studies Accelerate Drug Development and Reduce Risk
- Why Non-GLP Studies Matter in Preclinical Drug Development
- From Molecule to IND: A Strategic Roadmap Through Preclinical Studies
- Key Challenges in Oligonucleotide Bioanalysis—And How to Overcome Them
- What Is Large Molecule Preclinical Testing? Overview, Objectives, and Key Test Methods
- 6 Strategies to Overcome PROTACs’ Developmental Challenges
- The Future of Precision Medicine: How Bioanalysis is Transforming Personalized Healthcare
- Bioanalysis of ADC Drugs by LC-MS/MS
- 5 Tips to Navigating Antisense Oligonucleotide Drug Development
- Key Toxicology Considerations for Large-Molecule Therapies
- Overcoming the challenges of preclinical evaluations for PROTACs
- Bioanalytical Strategies for Fusion Proteins
- What Is Small Molecule Preclinical Testing? Overview, Objectives, and Key Test Methods
- Making the Most of the Golden Age of Small-Molecule Oncology Drugs
- Evaluation of Immunogenicity for Oligonucleotide Drugs
- LCMS Preclinical Bioanalysis of LNPs in Advanced Therapy Drugs
- 3 DMPK Strategies for ADC Drugs
- Bioanalytical Strategies for Evaluating Immunogenicity in Next-Generation AAV Therapies
- Advancing Oligonucleotide Drug Development with Ligand Binding Assays in the Preclinical Stage
- Bioanalysis of GLP-1 Antagonist Drugs by Multiple Analytical Platforms
- Overcoming nonspecific binding challenges in PK assays
- Bioanalytical Strategies for Peptide-Drug Conjugates (PDCs): Optimized Approaches for the Pharmaceutical Industry
- Validating Flow Cytometry-Based Micronucleus Assays in Alternative Species
- How to Evaluate the Preclinical Safety of Oligonucleotide Drugs
- Understanding the Sensitivity and Accuracy of FOB Tests for CNS and non-CNS Targeted Compounds
- Ensuring Multi-Ion Channel Inhibition Assays are Accurate and Reliable
- Unlocking Drug Insights with Cutting-Edge Molecular Imaging Solutions
- Small vs. Large Molecule Bioanalysis: 7 Key Differences
- When to Start Subchronic & Chronic Toxicology Studies
- Clinical Bioanalysis Strategy for Antibody Drug Conjugates (ADCs)
- Biological Significance and Bioanalytical Strategies of Biomarkers – Complement Detection
- Why are GLP Toxicology Studies Important?
- Designing Juvenile Toxicology Studies: Key Considerations for Drug Development
- How Radionuclide Drug Conjugates are Transforming Cancer Treatment
- 5 Ways You Can Automate Preclinical Bioanalysis
- Targeting the Untargetable: How Oligonucleotide Drugs Address Undruggable Proteins
- The Advantages of LC-MS/MS in Optimizing ADC Bioassays
- The Essential Role of Biomarkers in Modern Medicine: From Disease Diagnosis to Treatment Optimization
- Application of Protein Biomarkers in Pharmaceutical Research and Bioanalysis Strategies
- Why Communication is Essential to Non-clinical Testing
- The Vital Role of Toxicity Studies in New Drug Development
- IND Studies: Understanding Early-Stage Regulatory Needs
- Unlocking the Potential: Navigating Non-Clinical Programs for Biotherapeutics
- Everything Drug Developers Need to Know to Prepare for IND Submissions
- Key Components of IND Study Strategy Planning
- A Step-By-Step Guide to Successful IND Studies
- Finding the Best Lab Partner for your IND Submission
- A Step Forward in Oligo Therapy: A New Assay for Testing Oligo Stability in Plasma
- Application of qPCR Technology in the Bioanalysis of Oligonucleotide Drugs
- 3 Benefits of In Vitro ADME Testing Automation
- Innovative Bioanalytical Strategies for Oligonucleotide Therapeutics: A New Frontier in American Drug Development
- 6 Types of Toxicology Studies for IND & NDA Programs
- Bridging Cultures, Breaking Barriers: WuXi AppTec Women Leading the Way in Drug Development
- Innovations in Drug Development: The Increased Utility of In Vitro Testing
- SOT’s 2024 Annual Meeting: Showcasing Scientific Advancement & Celebrating Milestones
- Is Your Drug Ready for Preclinical Toxicological Testing?
- What Toxicity Data Is Needed Before First-In-Human (FIH) Trials?
- Striking the Right Balance: Linker Design in ADC Cancer Therapies
- ELISpot Assays: The Key to Unlocking Advanced Cellular Immunity Testing
- The Crucial Role of Biomarkers in the Precision Medicine Revolution
- Acute Toxicity Studies: 3 Best Practices to Stay on Track with Your IND Timeline
- 3 Common Missteps in Nonclinical Safety Assessment Testing
- What Is IND-Enabling Testing & What Does It Include?
- Oligonucleotide Development: History, Pain Points & Bioanalytical Considerations
- Basic Questions Developers Are Asking About In Vitro-In Vivo Extrapolation
- Good Communication Essential To Successful Preclinical Testing
- Understanding Differences in Regulatory Requirements Vital to Efficient Design of Preclinical Programs
- PROTACs and Their Role in Catalyzing Health Solutions
- An Important First Step in the Design of a Preclinical Program
- Pathologists Can Move Your Drug Development Program Forward
- WuXi AppTec Grows Biomarker Capabilities with Quanterix
- 5 Questions When Planning a Nonclinical Toxicology Program for Biotherapeutics
- You’ve Got Molecules, We’ve Got Solutions
- Partner Up – A Nonclinical Talk with Toxicology Consultant, Grace Furman
- Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development
- Internal Standard Variation Case Studies: A Look into the Latest Whitepaper
- Regulatory Pathways: IND Requirement Variations Between U.S. FDA, OECD and NMPA
- Ensure a Successful Clinical Translation with DMPK Strategies
- Transitioning to Phase I Clinical Trials
- Dual Filing your IND Package: Planning Pays Off
- New U.S. FDA DDI Draft Guidance for Therapeutic Proteins
- ACT Annual Meeting: Managing Roadblocks to Success
- In Vivo PK/ADME Studies — Positioning, Planning and Best Practices
- Immunoaffinity Purification using LC-MS/MS: Comparing Two Methods
- Webinar: Practical Implications of Recent Changes to Immunogenicity Risk Assessment
- Providing Support for Drug Discovery and Non-GLP Bioanalysis
- What You Need To Know Planning for an IND Submission
- Preclinical Testing
- GLP vs. Non-GLP toxicology studies: When to use which guidelines?
- Navigating the Path from IND to NDA
- Rapid EMSA: A New Method of Testing PPB in Oligonucleotides
- Drug Solubility Testing: 4 Ways It Helps Drug Discovery & Development
- Oligos for Ocular Diseases: Overcoming the Challenges
- 7 Most Common Bioanalytical Testing Platforms for Small and Large Molecule Bioanalysis
- Flux Dialysis: A Cutting-Edge Tool for PPB Studies & Understanding DDI
- Metabolic Stability in Drug Development: 5 Assays
- Repeat Dose Toxicity: 3 Possible Timeframes for Your IND-Enabling Studies
- 3 Must-Have Qualities of a Bioanalytical Method Development & Validation Partner
- From screening to IND submission: Biomarker analysis in preclinical drug development
- Early ADME Screening: 3 Ways It Boosts IND Submission Success
- What Are Metabolite Profiling & Identification Studies?
- Drug-Drug Interaction: An Overview of Substrates and Metabolizing Enzymes
- The Inherent Challenges of Antibody-Drug Conjugate (ADC) Bioanalysis
- 4 Critical In Vitro Genotoxicity Assays for Preclinical Drug Development
- Reproductive Toxicology & the EPA’s Tiered Testing System
- 5 Critical Nonclinical Toxicology Studies Required for IND Submission
- 6 Essential Qualities in a Drug Safety Assessment Testing Partner
- Preparing Drug Developers for Developmental and Reproductive (DART) Studies
- WuXi AppTec Expands Toxicology Footprint, Capabilities with New Chengdu Facility
- Q&A: How Preclinical Toxicology Contributes to Successful IND Applications
- The Vital Role Of Toxicity Studies In Evaluating New Drugs
- The Complex Process of Developing a Living Protocol
- How Bioanalytical Laboratory Automation Improves Timelines and Accuracy
- Testing Toxicity to Advance to Phase I Clinical Trials
- Managing Critical Reagents: An Essential Part of Your Bioanalytical Strategy
- Information Exchange is Essential Prior to Designing Preclinical Drug Development Programs
- Understanding New Modalities: Oligonucleotides and Bispecific Antibodies
- Grand Opening of New R&D Center in China
- ICH M10: Preview New Bioanalytical Method Validation Guidance
- How DMPK Lead Optimization Mitigates Risk and Conserves Resources
- WuXi AppTec & Quanterix Simoa Joint Lab Opening Ceremony
- Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites
- Virtual Tours Available Today
- Regulatory
- Dose Range-Finding Studies for Safety Assessment: 3 Reasons Not to Skip Them
- 4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing
- A New Method to Improve Identification of the Payload-Containing Catabolites of ADCs
- Improving PROTAC Drugs with MetID Studies
- Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways
- U.S. FDA Updates to Guidance on Managing Drug-Drug Interactions
- Regulatory Expertise
- Technical Expertise
- Toxicology Studies in Drug Development: What Programs Often Underestimate
- Acute Toxicity Studies: Best Practices for First-In-Human Readiness
- Maximum Tolerated Dose (MTD): How Dose-Range Finding Drives IND Success
- What Is MTD in Drug Development, and Why It’s More Than a Number
- The Bioanalytical Challenges of In Vivo CAR-T Therapy Development
- How to Address Metabolite Identification Challenges in Advanced Peptide Therapeutics
- EU New Drug Applications: 5 Tips to Prepare for Scientific Advice Requests
- Peptide Development: A Tiered DMPK Approach to Bridge Discovery and IND-enabling Studies
- Three Tips for Addressing the Complex Toxicity of ADCs
- NAMs: Defined Approaches for Skin Sensitization Studies
- A New Oligo Playbook: Building a Tailored, Risk-Based Strategy to a Successful IND
- Why Half-Life Extension Isn’t Enough: A 4-Step ADME Strategy for Peptide IND Readiness
- IND-Enabling Studies: How to Integrate ADME, Bioanalysis, and Tox for a Successful IND
- IND Application Essentials: What Data Regulators Actually Scrutinize
- From IND to Clinic: Lab Testing Milestones in Early Clinical Trials
- IND Submission Strategy: Common Gaps That Delay First-in-Human Studies
- AOCs Explained: Delivery, DMPK, and the Future of Antibody Oligonucleotide Conjugates
- Oncolytic Virus Therapies: Key Considerations for Clinical Bioanalysis
- Alzheimer’s Disease Biomarkers: Toward More Precise Testing
- In Vitro ADME Testing: When It’s Enough – and When It’s Not
- Why Metabolite Identification Is a Regulatory Decision Point, Not Just a DMPK Exercise
- PK Study Design: Avoiding Rework in Early Pharmacokinetics
- How to Validate Whole Slide Imaging for Toxicological Pathology
- Moving From GLP-1 to Multi-Target Metabolic Medicines
- Five Ways PROTACs Break From ADME Norms
- Beyond Single-Marker Pathology: How Highly Multiplex Fluorescence Imaging Is Expanding Translational Research
- ELISA v LC-MS/MS: Preclinical Bioanalysis Platforms for ADCs in Focus
- How Biomarker Testing Services Support Precision Medicine Programs
- Preclinical vs. Clinical Biomarkers: Differences That Matter
- Biomarker Assays in Drug Development: Choosing the Right Platform
- Biomarker Assays: Designing Assays That Scale from Preclinical to Clinic
- Beyond Targeting: How ADC Payloads Drive Toxicity and IND Risk
- Bioanalytical Method Development and Validation: What IND Sponsors Need to Know
- What Is Bioanalytical Method Validation? A Guide to Regulatory Expectations
- How Bioanalytical Laboratory Services Reduce Risk in Preclinical Programs
- 7 Common Bioanalytical Services Pitfalls That Delay IND Timelines
- Four Tips to Optimize Transdermal Drug Delivery
- Five Tips for Toxicology and Emerging Modalities | WuXi AppTec
- NAMs in Focus: The Evolution of Skin Irritation and Corrosion Testing Based on Reconstructed Human Epidermis Models
- Key Safety Considerations During Oligonucleotide Development
- De-Risk Your IND and NDA: Avoid These 5 DART Pitfalls
- Peptide Drug Conjugates: Analytical and PK Considerations
- Antibody Drug Conjugate Services: Overcoming Bioanalysis Challenges
- PROTAC Services: Navigating DMPK and Bioanalytical Complexities
- mRNA Analytical Services: What Makes Testing Fit-for-Purpose
- Three Strategies to Address Development Challenges for Next-Generation Peptide Therapeutics
- Better In Vivo Model Welfare, Better Data: A Preclinical Playbook
- Four Tips to Help Unlock Oligonucleotide Therapies for the Central Nervous System
- ADCs and Ocular Toxicity: Mechanisms and Management
- Six Ways Developers Can Address Ocular Safety in ADCs
- Five Tips to Tackle the Bioanalytical and PK Challenges of ADC Development
- Advancing Preclinical Bioanalytical Strategies for GLP-1 Receptor Agonists
- A New Playbook: 5 Ways to Improve Safety & Decision-Making With In Vitro Toxicology
- IND-Ready Immunotoxicity: Four Decisions to Prevent Late Surprises
- 2 Analytical Platforms for Peptide Preclinical Testing: LC-MS & ELISA
- 3 Important DMPK Considerations for Successful Peptide Preclinical Testing
- Advancing Preclinical Bioanalytical Strategies for Today’s Diverse Vaccine Platforms
- WuXi AppTec Launches R&D Center for Large Animal PK & Non-GLP Bioanalytical Research Services
- Revolutionizing Plasma Protein Binding Determination with Echo® MS
- Decoding Complex Metabolite Related Drug-Drug Interactions
- Drug-Drug Interaction: An Overview of Inhibitors
- The Many DMPK Challenges of Cancer Treatment ADCs
- What Is Bioanalytical Testing & Method Validation?
- QWBA and Mass Balance Studies
- How to Improve PROTACs’ Oral Bioavailability
- How to Tackle the Developmental Challenges of PROTAC Drugs
- A Guide to In Vitro ADME Testing in Drug Development
- Simoa Joint Laboratory Delivering Greater Speed, Sensitivity and Customization in Biomarker Validation
- Join WuXi AppTec at the 2021 American Association of Pharmaceutical Scientists PharmSci 360
- Join WuXi AppTec at the 42nd American College of Toxicology Annual Meeting