tailieunhanh - HPLC for Pharmaceutical Scientists 2007 (Part 1)

In the modern pharmaceutical industry, high-performance liquid chromatography (HPLC) is the major and integral analytical tool applied in all stages of drug discovery, development, and production. The development of new chemical entities (NCEs) is comprised of two major activities: drug discovery and drug development. The goal of the drug discovery program is to investigate a plethora of compounds employing fast screening approaches, leading to generation of lead compounds and then narrowing the selection through targeted synthesis and selective screening (lead optimization). This lead to the final selection of the most potentially viable therapeutic candidates that are taken forward to. | PART I HPLC THEORY AND PRACTICE 1 INTRODUCTION Yuri Kazakevich and Rosario LoBrutto CHROMATOGRAPHY IN THE PHARMACEUTICAL WORLD In the modern pharmaceutical industry high-performance liquid chromatography HPLC is the major and integral analytical tool applied in all stages of drug discovery development and production. The development of new chemical entities NCEs is comprised of two major activities drug discovery and drug development. The goal of the drug discovery program is to investigate a plethora of compounds employing fast screening approaches leading to generation of lead compounds and then narrowing the selection through targeted synthesis and selective screening lead optimization . This lead to the final selection of the most potentially viable therapeutic candidates that are taken forward to drug development. The main functions of drug development are to completely characterize candidate compounds by performing drug metabolism preclinical and clinical screening and clinical trials. Concomitantly with the drug development process the optimization of drug synthesis and formulation are performed which eventually lead to a sound and robust manufacturing process for the active pharmaceutical ingredient and drug product. Throughout this drug discovery and drug development paradigm rugged analytical HPLC separation methods are developed and are tailored by each development group . early drug discovery drug metabolism pharmokinetics process research preformulation and formulation . At each phase of development the analyses of a myriad of samples are performed to adequately control and monitor the quality of the prospective drug candidates excipients and final products. Effective and fast method development is of HPLC for Pharmaceutical Scientists Edited by Yuri Kazakevich and Rosario LoBrutto Copyright 2007 by John Wiley Sons Inc.