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Changing need for bioanalysis during drug development
Author(s) -
Srinivas Nuggehally R.
Publication year - 2008
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.932
Subject(s) - bioanalysis , drug development , drug discovery , nanotechnology , authorization , chemistry , engineering ethics , data science , biochemical engineering , computer science , drug , pharmacology , engineering , medicine , chromatography , biochemistry , materials science , computer security
Recent years have witnessed the introduction of several high‐quality review articles into the literature covering various scientific and technical aspects of bioanalysis, including chirality aspects. Now it is widely accepted that bioanalysis is an integral part of the pharmacokinetic/pharmacodynamic characterization of a novel chemical entity (NCE) from the time of its discovery and during various stages of drug development leading to its market authorization. There is a need for a comprehensive review article that takes into account the changing faces of bioanalysis from the time of inception of an NCE at the discovery stage and as the NCE moves forward in development. This review attempts to cover the versatility in the applicability of bioanalytical aspects with respect to the nature, rigor and available choices of analyses. For ease of understanding, bioanalytical aspects are discussed under sections covering discovery, preclinical and clinical stages. It is intended to give some general thoughts in this area which will form basis of a general framework as to how one would approach bioanalysis from inception (i.e. discovery of a lead molecule) and progressing through various stages of drug development. Copyright © 2007 John Wiley & Sons, Ltd.