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Pharm Methods. 2010 Oct;1(1):14-24. doi: 10.4103/2229-4708.72223.

Bioanalysis in drug discovery and development.

Pharmaceutical methods

Saurabh Pandey, Preeti Pandey, Gaurav Tiwari, Ruchi Tiwari

Affiliations

  1. Pranveer Singh Institute of Technology, Bhauti, Kanpur, Uttar Pradesh, India.

PMID: 23781412 PMCID: PMC3658019 DOI: 10.4103/2229-4708.72223

Abstract

Recent years have witnessed the introduction of several high-quality review articles into the literature covering various scientific and technical aspects of bioanalysis. Now it is widely accepted that bioanalysis is an integral part of the pharmacokinetic/pharmacodynamic characterization of a novel chemical entity from the time of its discovery and during various stages of drug development, leading to its market authorization. In this compilation, the important bioanalytical parameters and its application to drug discovery and development approaches are discussed, which will help in the development of safe and more efficacious drugs with reduced development time and cost. 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.

Keywords: Bioanalytical; metabolism; method validation; pharmacokinetics; toxicokinetic

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