生物学的同等性とバイオアベイラビリティのジャーナル

概要

Role of Pharmacokinetic Studies in Drug Discovery

Nishant Toomula, Sathish Kumar D, Arun Kumar and Phaneendra M

Over the last few years, Pharmacokinetics has emerged as an integral part of drug development, especially when identifying a drug’s biological properties. Understanding of pharmacokinetic and metabolism characteristic of the drug compounds is needed in designing appropriate human clinical trials. This document describes the basic principles of pharmacokinetic studies necessary for the submission of a new drug application and for re-examination of approved drugs.