Chirality in Drug Design and Development 第10章.pdf

10 Regulatory Considerations in Drug Development of Stereoisomers Chandra Sahajwalla Food and Drug Administration, Rockville, Maryland, U.S.A. 1. INTRODUCTION This chapter deals with some of the regulatory issues that need to be considered at the time of developing a drug with chiral center(s). Before we discuss regulatory issues in developing chiral drugs, a brief discussion of drug development and its regulatory process is warranted. 1.1. Drug Development and the Regulatory Process The regulatory drug development process for new drugs has evolved over the years. Development of drug law dates back to 1906 when the Federal Food and Drug act was enacted, but the FDA had no role in premarketing evaluation of drugs. In 1962, for the first time, a drug had to be shown to be effective. Subsequently, guidelines to format and content of the clinical and statistical sections of the drug application were issued in 1988. Only then were there attempts to discern dose–response relationships in adverse events, and to examine the rates of adverse events in demographics (age, race, gender) and other subgroups (metabolic status, renal function). The views expressed in this article are those of the author’s and do not reflect the official