Regulatory

The Vital Role Of Toxicity Studies In Evaluating New Drugs

The Vital Role Of Toxicity Studies In Evaluating New Drugs

The evaluation of toxicity in a new drug is a very thorough process, so that by the end of the testing, scientists will have compiled all the necessary data to understand the full safety profile of the potential new drug. During that nonclinical evaluation, there are...

Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways

Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways

Introducing new drug candidates to preclinical testing is a complex and time-consuming endeavor. It can cost developers more than $1 billion and take a decade to bring a new drug to market. Success rates vary depending on therapeutic area, but a recent study from MIT...

Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites

Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites

Recent guidance from the U.S. Food and Drug Administration (FDA) on Safety Testing of Drug Metabolites helps drug developers know when and how to identify and characterize drug metabolites. Identifying and characterizing a drug's metabolic profile is a necessary step...

Virtual Tours Available Today

Virtual Tours Available Today

Explore our New Jersey facilities from wherever you are working, even the comfort of your own home. Virtually tour our New Jersey facilities in Cranbury and Plainsboro to learn about our Bioanalytical and DMPK capabilities and instrumentation to support your drug...