ABSTRACT

The views expressed in this article are those of the author’s and do not reflect the official policy of the FDA. No official support or endorsement by the FDA is intended or should be inferred.

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.