Mehul Mehta
The Office of Clinical Pharmacology (OCP) is a part of the Center for Drug Evaluation and Research (CDER) at the FDA. OCP probably comprises the largest group of scientists with expertise in, and involved with, the evaluation of all aspects of clinical pharmacology in new drug development, approval, and lifecycle management. Over a series of two parts, details are covered about the growth of this office over the last 40 years from one small Division of Biopharmaceutics (DB) in 1986, with staff of approximately 30 members carrying a large backlog of applications, to the current OCP of approximately 270 scientists with needed resources to carry out thousands of reviews and industry meetings in a timely manner. The growth of OCP is detailed with milestone developments in the areas of biopharmaceutics (BP) and clinical pharmacology (CP) science, which became a part of the review focus of new drug and biological applications over the last 40 years. Relevant regulations, guidances and some of the seminal articles/drug approvals highlighting critical contributions of the emerging components of OCP are also briefly covered. The parallel growth of CDER and enactment of new critical legislation requiring this growth are also summarized. In this first part, the organizational evolution of the OCP and the first segment of its scientific growth, i.e., bioanalysis, specific topics in the areas of bioavailability (BA) and bioequivalence (BE), biosimilars, and new drug applications (NDAs) based on Sect. 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDC Act), are covered. Part II covers the areas of metabolism and drug‒drug interactions (DDIs), including DDI-induced cardiotoxicity of terfenadine, special populations, pediatric efficacy extrapolation, pharmacogenomics, quantitative clinical pharmacology (QCP), and conclusions.