PK/PD Studies Included In Less Than 25% Of NDA Filings - FDA's Lesko
This article was originally published in The Tan Sheet
Executive Summary
Fewer than one quarter of NDAs submitted in the past three years included pharmacokinetic/pharmacodynamic studies, FDA Office of Clinical Pharmacology and Biopharmaceutics Director Lawrence Lesko, PhD, told an American Association of Pharmaceutical Scientists meeting Sept. 9 in Washington, D.C.