Preclinical Safety

Ensure a Successful Clinical Translation with DMPK Strategies

Ensure a Successful Clinical Translation with DMPK Strategies

DMPK - A Key Step, Every Step of the Way Drug metabolism and pharmacokinetics (DMPK) is a crucial component in the success of your drug development – at every stage, from discovery to preclinical to clinical. DMPK studies set basic expectations of drug behavior, which...

Transitioning to Phase I Clinical Trials

Transitioning to Phase I Clinical Trials

Developing biologic solutions is a complex process, and bridging bioanalytical assays from preclinical to phase I clinical trials is a demanding step in advancing your therapeutic. While maneuvering through regulatory requirements and intensive testing, it is easy for...

Dual Filing your IND Package: Planning Pays Off

Dual Filing your IND Package: Planning Pays Off

Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...

ACT Annual Meeting: Managing Roadblocks to Success

ACT Annual Meeting: Managing Roadblocks to Success

One of the largest shares of preclinical testing in any drug development program is toxicology studies, yet bringing together the community supporting this pivotal development stage does not happen often enough. Fortunately, the 2020 American College of Toxicology...

Alliances for Innovation: Insight from Steve Yang

Alliances for Innovation: Insight from Steve Yang

In the face of a wide-spread pandemic, something extraordinary is happening in the drug development industry – competitors are becoming collaborators and collaborations are accelerating results. WuXi AppTec’s Co-CEO, Head of RSD, Head of WuXi Testing, Steve Yang,...

Immunoaffinity Purification using LC-MS/MS: Comparing Two Methods

Immunoaffinity Purification using LC-MS/MS: Comparing Two Methods

Protein quantitation by liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become an increasingly popular field for pharmacokinetics study in the drug discovery phase. Traditional method development using a ligand binding assay usually requires 2-3 months....

Providing Support for Drug Discovery and Non-GLP Bioanalysis

Providing Support for Drug Discovery and Non-GLP Bioanalysis

Speed is essential for your in vitro and in vivo screening during drug discovery. Whether you are developing a small or large molecule drug, working with the right bioanalytical team is essential to your success. Look for a partner that provides comprehensive services...

Tracking Your Molecule: Technology Advancements in the Industry

Tracking Your Molecule: Technology Advancements in the Industry

Molecule tracking via preclinical testing is a significant yet necessary investment for drug developers. The stakes are high, and it's critical to stay apprised of your program's progress from start to finish. You need to monitor how your compound is progressing and...