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preclinical testing

Testing Toxicity to Advance to Phase I Clinical Trials

Testing Toxicity to Advance to Phase I Clinical Trials

Preclinical research teams enter each drug testing project with the same hope – that the drug will meet all the safety requirements in order to advance to phase I clinical trials in humans.  In laboratory experiments, scientists will test their ideas for new...

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...

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New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins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