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IND Studies: Understanding Early-Stage Regulatory Needs

IND Studies: Understanding Early-Stage Regulatory Needs

Bringing new drugs and therapeutics to a global market requires extensive planning. Requirements for soliciting early-stage regulatory feedback differ across geographies, so it might be tempting to file new drug submissions separately.

Key Components of IND Study Strategy Planning

Key Components of IND Study Strategy Planning

A successful Investigational New Drug (IND) submission requires a comprehensive testing approach. From Drug Metabolism and Pharmacokinetic (DMPK) studies to determine the drug’s behavior within the body, nonclinical toxicology assessments to meticulously examine its safety profile, and Bioanalytical studies to measure drug concentrations in biological samples, the process plays a critical role in drug development.

A Step-By-Step Guide to Successful IND Studies

A Step-By-Step Guide to Successful IND Studies

Investigational New Drug (IND) studies play an essential role in the drug development journey. This testing helps researchers foresee safety concerns and estimate the most efficacious starting doses for clinical trials.

Finding the Best Lab Partner for your IND Submission

Finding the Best Lab Partner for your IND Submission

A successful Investigational New Drug (IND) application is imperative for research involving human participants ingesting or applying a drug product. Sponsors can take several potential regulatory pathways, but all pose unique challenges and requirements. The right laboratory testing partner can ease this process, avoiding longer timelines and bloated budgets. Drug sponsors should consider these three key areas before selecting a lab partner.

A Step Forward in Oligo Therapy: A New Assay for Testing Oligo Stability in Plasma

A Step Forward in Oligo Therapy: A New Assay for Testing Oligo Stability in Plasma

Oligonucleotides (oligos), including small interference RNAs (siRNAs) and antisense oligonucleotides (ASOs), represent a novel class of therapeutic agents capable of precisely targeting and regulating gene expression. This precision allows the potential treatment of various diseases, from genetic disorders to cancers, by silencing harmful genes or correcting genetic abnormalities.

3 Benefits of In Vitro ADME Testing Automation

3 Benefits of In Vitro ADME Testing Automation

In vitro ADME assays provide the data necessary to ensure the safety and efficacy of your drug candidates. Automating these tests can shorten the time it takes your product to reach the market.