Case Study: Achieving a 505(b)(2) Regulatory Approval for Multiple NDA-Enabling Studies
Hybrid medicines are drugs based on an approved active substance (or previously approved drug) and have a different route of administration, format, strength, or indication from the original reference product.
They require approval for market authorization based on both data from the original reference medicine, and from new clinical trials on the modified version.
Case Study—Accelerating Recruitment in Renal Impairment Trials: Leveraging Specialized External Sites
7 Tips for Navigating the Complexities of In Vitro NAMs Studies
As a board-certified toxicologist and experienced Good Laboratory Practices (GLP) Consultant, I spend quite a bit of time advising on quality issues of New Approach Methodologies (NAMs) in support of toxicology programs. While these alternative methods are exciting and full of promise, they come with their own set of challenges.
STAT: Responsible AI Frees Scientists to Focus on Science
The CEO Views: Altasciences—Streamlining Drug Development Decision-Making
CLINDMO: Where Clinical Innovation Meets Manufacturing Excellence