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LC/MS applications in drug development
Author(s) -
Lee Mike S.,
Kerns Edward H.
Publication year - 1999
Publication title -
mass spectrometry reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 126
eISSN - 1098-2787
pISSN - 0277-7037
DOI - 10.1002/(sici)1098-2787(1999)18:3/4<187::aid-mas2>3.0.co;2-k
Subject(s) - chemistry , drug development , biochemical engineering , scope (computer science) , drug discovery , pharmaceutical industry , new product development , drug , nanotechnology , emerging technologies , automation , risk analysis (engineering) , process engineering , computer science , microbiology and biotechnology , engineering , pharmacology , business , medicine , mechanical engineering , biochemistry , materials science , marketing , biology , programming language
The combination of high‐performance liquid chromatography and mass spectrometry (LC/MS) has had a significant impact on drug development over the past decade. Continual improvements in LC/MS interface technologies combined with powerful features for structure analysis, qualitative and quantitative, have resulted in a widened scope of application. These improvements coincided with breakthroughs in combinatorial chemistry, molecular biology, and an overall industry trend of accelerated development. New technologies have created a situation where the rate of sample generation far exceeds the rate of sample analysis. As a result, new paradigms for the analysis of drugs and related substances have been developed. The growth in LC/MS applications has been extensive, with retention time and molecular weight emerging as essential analytical features from drug target to product. LC/MS‐based methodologies that involve automation, predictive or surrogate models, and open access systems have become a permanent fixture in the drug development landscape. An iterative cycle of “what is it?” and “how much is there?” continues to fuel the tremendous growth of LC/MS in the pharmaceutical industry. During this time, LC/MS has become widely accepted as an integral part of the drug development process. This review describes the utility of LC/MS techniques for accelerated drug development and provides a perspective on the significant changes in strategies for pharmaceutical analysis. Future applications of LC/MS technologies for accelerated drug development and emerging industry trends are also discussed. © 1999 John Wiley & Sons, Inc., Mass Spec Rev 18: 187–279, 1999