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Informationen zum Autor MIKE S. LEE, PhD, is President of Milestone Development Services, a consulting firm specializing in pharmaceutical analysis and drug development strategies. He lives in Newtown, Pennsylvania. Klappentext The premier reference on the cutting-edge technology driving new drug developmentBreakthroughs in combinatorial chemistry and molecular biology, as well as an overall industry trend toward accelerated development, mean the rate of sample generation now far exceeds the rate of sample analysis in the pursuit of producing new and better pharmaceuticals. LC/MS is an analytical tool that helps the researcher identify the most promising sample early in the selection process, effectively creating a shortcut to finding new drugs. This book is the first to describe LC/MS applications within the context of drug development, including the discovery, preclinical, clinical, and manufacturing phases.In addition to the thorough technical analysis of this tool, LC/MS Applications in Drug Development provides perspective on the significant changes in strategies for pharmaceutical analysis. A process overview of drug development from an analytical point of view is provided along with essential data required to successfully bring a drug to market. The incorporation of LC/MS is illustrated from target to product. Chapters pertaining to the discovery process itself include:* Proteomics* Glycoprotein Mapping* Natural Products Dereplication* Lead Identification Screening* Open-Access LC/MS* In Vivo Drug Screening* In Vitro Drug ScreeningWritten for both the analytical chemist who uses LC/MS applications and the pharmaceutical scientist who works with the drugs they produce, LC/MS Applications in Drug Development is the premier reference on the subject. Zusammenfassung In the arena of new drug development, the rate of sample generation far exceeds the rate of sample analysis. LC/MS is an analytical tool that helps the researcher select the most promising sample for scrutiny, accelerating the discovery of new drugs. This book is the first to describe in detail the procedures and benefits of LC/MS applications. Inhaltsverzeichnis Preface ix Acknowledgments xi 1. Introduction 1 Emerging Analytical Needs 1 Integration of LC/MS into Drug Development 3 Partnerships and Acceptance 6 Overview 10 2. Drug Development Overview 11 Analysis Perspectives 11 The Four Stages of Drug Development 12 Drug Discovery 14 Preclinical Development 15 Clinical Development 16 Manufacturing 17 3. Accelerated Drug Development 19 Accelerated Development Strategies 20 Quantitative and Qualitative Process Elements 20 Quantitative Process Pipeline 24 Qualitative Process Pipeline 25 Motivating Factors 27 Analysis Opportunities for Accelerated Development 28 Full-Time Equivalent 28 Sample Throughput Model 29 Elimination Model 29 Rate-Determining Event Model 31 Accelerated Development Perspectives 33 4. LC/MS Development 34 The Elements of LC/MS Application 34 HPLC 35 Mass Spectrometry 35 LC/MS Interface 36 LC/MS Growth 38 5. Strategies 41 Standard Methods 43 Template Structure Identification 46 Databases 49 Screening 50 Integration 53 Miniaturization 55 Parallel Processing 56 Visualization 58 Automation 61 Summary 63 6. LC/MS Applications 65 Drug Discovery 65 Proteomics 68 Protein Expression Profiling 70 Quantitation 76 Glycoprotein Mapping 78 Natural Products Dereplication 83 Lead Identification Screening 88 Bioaffinity Screening 89 Combinatorial Library Screening 92 Open-Access LC/MS 96 Structur...
