Pharmaceutical Analysis for Small Molecules (eBook, ePUB)

Redaktion: Davani, Behnam

• Format: ePub

Produktbeschreibung

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates--especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors--into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: * Drug Approval Process and Regulatory Requirements (private standards) * Pharmacopeias and Compendial Approval Process (public standards) * Common methods in pharmaceutical analysis (typically compendial) * Common Calculations for assays and impurities and other specific tests * Analytical Method Validation, Verification, Transfer * Specifications including how to handle out of specification (OOS) and out of trend (OOT) * Impurities including organic, inorganic, residual solvents and elemental impurities * Good Documentation Practices for regulatory environment * Management of Analytical Laboratories * Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 256
• Erscheinungstermin: 1. August 2017
• Englisch
• ISBN-13: 9781119425014
• Artikelnr.: 49060343

Autorenporträt

Behnam Davani, PhD, has more than 25 years' experience in analytical chemistry, compendial and regulatory science, QC/QA and cGMPs. He is Principal Scientific Liaison in the General Chapters Group, Science Division of the United States Pharmacopeia (USP). In this role, he coordinates the identification and scientific development of compendial courses for stakeholders worldwide. He is also an active faculty for USP Global Education and Training department and teaches several compendial courses including method validation/verification/transfer, impurities in drug substances and products, compendial HPLC, residual solvents, stability studies for drug substances and products, and spectroscopy. He has taught these courses in the US as well as to international regulatory bodies and global pharmaceutical industries including in Europe, Canada, China, India, Russia, Korea, Latin America, Middle East, and North Africa.

Inhaltsangabe

About the Editor xvi

List of Contributors xviii

Preface xxi

Acknowledgment xxv

1 Drug Approval Process and Regulatory Requirements 1

1.1 Introduction 1

1.2 The Regulatory Process for New Drug Entity 2

1.2.1 Preclinical Studies 2

1.2.2 Investigational New Drug Application (INDA) 2

1.2.2.1 Phase 1 Clinical 2

1.2.2.2 Phase 2 Clinical 3

1.2.2.3 Phase 3 Clinical 3

1.2.3 New Drug Application (NDA) 3

1.2.3.1 NDA Review by FDA 3

1.2.3.2 NDA Review Process 4

1.3 Good Laboratory Practice for Nonclinical Laboratory Studies 5

1.4 Validation of Analytical Procedures: Methodology 6

1.5 FDA Role in the Discovery and Development of New Drug Entities 7

1.5.1 INDA Analytical Requirements 7

1.5.2 NDA Analytical Requirements 8

1.5.3 Biotechnology?]Derived Products - Small Molecules 8

1.6 FDA Inspectors' Role in Analytics Relative to Products in the Marketplace 9

1.6.1 FDA Compliance Program Guidance Manual (Implemented on 09/11/2015 with a Completion Date of 09/11/2016 - Program 7356.002) 9

1.6.2 Guide for Inspection of Microbiological Pharmaceutical Quality Control Laboratories 10

1.6.3 Biotechnology Inspection Guide 11

1.7 Conclusions 12

References 12

2 Pharmacopeias and Compendial Approval Process 14

2.1 Introduction 14

2.2USP History 14

2.3 Evolution of the Mission of the USP 15

2.4 The USP Organization 16

2.4.1 The USP Convention 16

2.4.2 The Board of Trustees 16

2.4.3 The Council of Experts 16

2.4.4 Expert Panels to the Council of Experts 16

2.4.5 Stakeholder Forums and Project Teams 17

2.4.6 USP Staff 17

2.5 The USP-NF Revision Process 17

2.6 Publications of USP 18

2.6.1 USP?]NF 18

2.6.2 Pharmacopeial Forum 18

2.6.3 Supplements 18

2.6.4 USP Spanish Edition 18

2.6.5 USP Reference Standards 18

2.6.6 Chromatographic Columns 18

2.6.7 USP Dictionary 18

2.6.8 USP Dietary Supplements Compendium 19

2.6.9 Food Chemical Codex 19

2.6.10 USP Medicines Compendium 19

2.7 Relationship between USP and FDA 19

2.8 USP and the Pharmacopoeias of Europe and Japan 20

2.8.1 The European Pharmacopoeia 20

2.8.2 The Pharmacopeia of Japan 21

2.9 Harmonization of Pharmacopeial Monographs and General Chapters 21

2.9.1 PDG Working Procedures 22

2.9.2 Status of the Pharmacopeial Harmonization Initiative 25

2.9.3 Roles and Responsibilities of Major Stakeholders in Pharmacopeial Harmonization 28

2.9.4 The Roles and Responsibilities of Industry in Pharmacopeial Harmonization 29

2.9.5 The Roles and Responsibilities of the Regulatory Agencies in Pharmacopeial Harmonization 30

2.9.6 The Roles and Responsibilities of the International Conference on Harmonization (ICH) in Pharmacopeial Harmonization 30

2.9.7 Advantages of Pharmacopeial Harmonization 31

2.9.8 Disadvantages of Pharmacopeial Harmonization 31

2.10 Comparisons between the PDG Process and the ICH Process in Harmonization 32

2.11 The Special Case of Pharmacopeial Harmonization of Excipients 33

2.12 Retrospective versus Forward Pharmacopeial Harmonization 33

2.13 Conclusions and Recommendations 34

2.14 Final Thoughts 35

List of Abbreviations 35

References 36

3 Common Methods in Pharmaceutical Analysis 37

3.1 Scope