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Repeat Dose Toxicity: 3 Possible Timeframes for Your IND-Enabling Studies
Repeat dose toxicity studies evaluate the effects of repeat administration over a defined period of time. To get the right toxicity data, what is the right duration for your compound? This blog discusses three possibilities. Toxicity data from repeat dose studies...
3 Must-Have Qualities of a Bioanalytical Method Development & Validation Partner
To make well-informed decisions about the future of your drug candidate, you need highly accurate and reliable data. Generating such data starts with bioanalytical method development and validation – a precise process that requires support from your testing partner....
WuXi AppTec Launches R&D Center for Large Animal PK & Non-GLP Bioanalytical Research Services
A new 18,000-square-meters (~193,000 square feet) R&D center in Nantong will allow WuXi AppTec’s DMPK Team to meet the demand of a variety of projects, from screening PK to IND applications – while meeting international standards. In May 2023, WuXi AppTec...
Revolutionizing Plasma Protein Binding Determination with Echo® MS
Plasma protein binding (PPB) assays are critical in the drug discovery process. However, this stage of development can be complex, time-consuming and expensive. So, any advancement in the technology used to carry out PPB assays is welcome news for drug sponsors and...
3 Common Missteps in Nonclinical Safety Assessment Testing
Safety assessment testing is one of the most involved and complex pieces of an already time-intensive and costly drug development process. Any missteps here can have drastic implications on the rest of your development program. Here are three common pitfalls to avoid....
From screening to IND submission: Biomarker analysis in preclinical drug development
In preclinical drug development, biomarkers are used to quantify drug safety and response. In this blog, we trace the use of biomarkers across this spectrum with tips along the way. Biomarker analysis is a critical piece of drug development that helps provide a...
Early ADME Screening: 3 Ways It Boosts IND Submission Success
Thorough testing of the absorption, distribution, metabolism, and excretion (ADME) properties of a compound has significant downstream effects on the potential success of a drug. Here’s how early ADME screening in particular helps propel you to a successful IND...
Decoding Complex Metabolite Related Drug-Drug Interactions
Drug-drug interaction (DDI) signifies an essential facet of pharmacological science, given its influence on drug efficacy and the potential for adverse events. DDI occurs when the pharmacological or clinical response to a drug is altered by the presence of another...
Drug-Drug Interaction: An Overview of Inhibitors
Unexpected side effects can occur when two or more drugs are co-administered. These are called Drug-Drug Interactions (DDIs). Most drugs rely on enzymes to be metabolized. These interactions can alter the efficacy of a drug and potentially be harmful or less...
Tackling Development and Regulatory Challenges for Gene Therapies
Gene therapies have been one of the fastest-growing fields of drug development. These therapies hold the potential to treat cancers and other “undruggable” diseases and could hold the key to saving millions of lives. But they also have unique characteristics that make...
Dose Range-Finding Studies for Safety Assessment: 3 Reasons Not to Skip Them
Are you ready for your GLP toxicology studies? Not without dose range-finding studies, you aren’t. Here are 3 reasons why these can’t be skipped. A well-planned preclinical toxicology program always starts with the end in mind. In the case of dose levels, then, you...
4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing
DMPK testing helps drug developers investigate how a drug compound is absorbed, distributed, metabolized, and eliminated (ADME) by the body. The earlier these properties can be understood, the better – which is why many drug developers start the process with non-GLP...