Introduction

The regulation and control of new drugs in the United States has been based on the new drug application (NDA) that is evaluated by the U.S. Food and Drug Administration (FDA). The data gathered in preclinical studies and human clinical trials as an investigational new drug (IND) during the drug development process become part of the NDA. The goal of the drug development process is to provide sufficient information to the FDA in the NDA to evaluate the efficacy and safety of the new drug as well as recommendations to adjust the dose in special circumstances. The drug development process for new drugs has evolved over the years especially in the field of Clinical Pharmacology and Biopharmaceutics. In response to the

* Current affiliation: Aventis Pharmaceuticals, Bridgewater, New Jersey, U.S.A.

evolving technology, advancement of knowledge in the field, and to ascertain consistency and quality of the data available during the development process, the US FDA, including, office of clinical pharmacology and biopharmaceutics (OCPB) has issued several regulatory guidance documents. Office of clinical pharmacology and biopharmaceutics has several guidances in the public domain that are available to drug companies (often referred to as sponsors) which provide recommendations in the areas of clinical pharmacology/ biopharmaceutics such as exposure-response assessments, design and conduct of population pharmacokinetic studies, in vitro and in vivo drug metabolism and drug interactions, dissolution testing requirements for immediate and extended release dosage forms, design and conduct of bioavailability, bioequivalence and food-effect studies, and studies in patients with renal and hepatic impairment. This chapter integrates the information from available OCPB and other FDA-issued guidances that aid in the drug development process, and also provides insight into some of the issues that should be considered from a regulatory perspective regarding the Clinical Pharmacology and Biopharmaceutics aspects of drug development. It should be noted that some of the guidances are published as a draft and reflect current scientific understanding and thinking of the FDA scientist.

The sponsors now have option submitting new drug application in NDA format or Common Technical Document (CTD) format. Common technical document format is a format in which clinical, pharmacology/ toxicology and manufacturing data can be submitted to obtain marketing authorization for new drugs in the United States, European Union, and Japan. It should however be noted that CTD and NDA do not differ in the content of the information but mainly the format in which data should be provided.

This chapter provides an insight into the review process by the Clinical Pharmacology and Biopharmaceutics staff.

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