Specification of Drug Substances and Products

Development and Validation of Analytical Methods

Häftad, Engelska, 2020

AvChristopher M. Riley,Thomas W. Rosanske,George L. Reid,USA) Riley, Christopher M. (President of Riley and Rabel Consulting Services, Maryville, MO,USA) Rosanske, Thomas W. (Consultatnt, Lee's Summit, MO,USA) Reid, George L. (Principal Consultant, Cardinal Health, Kansas City, MO

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.

The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.

Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
Written by subject-matter experts involved in the development and application of the guidelines
Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Produktinformation

Utgivningsdatum2020-07-24
Mått191 x 235 x undefined mm
Vikt1 540 g
FormatHäftad
SpråkEngelska
Antal sidor694
Upplaga2
FörlagElsevier Science
ISBN9780081028247

Tillhör följande kategorier

Farmakologi inom Medicin
Kemi inom Naturvetenskap och teknik
Analytisk kemi inom Naturvetenskap och teknik
Organisk kemi inom Naturvetenskap och teknik

Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor’s degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms.Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

PART 1 INTRODUCTION1. Introduction 2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting 3. General Principles and Regulatory Considerations: Method Development and Validation 4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 5. Analytical Methods in the Clinical Phase of Development 6. Method Transfer 7. Process Analytical TechnologyPART 2 UNIVERSAL TESTS8. Description and Identification 9. Assay and Impurities: Specifications 10. Assay and Impurities: Method Development and Life-Cycle Management 11. Assay and Impurities: Method Validation 12. Mutagenic Impurities 13. Residual Solvents 14. Inorganic Impurities (Elemental Impurities)PART 3 SPECIFIC TESTS: DRUG SUBSTANCES15. Solid State Characterization 16. Chiral Methods 17. Water Determination PART 4 SPECIFIC TESTS DRUG PRODUCT18. Drug Release: Oral Products 19. Topical Products 20. Extractables and Leachables PART 5 BIOTECHNOLOGY PRODUCTS21. Regulatory Requirements for Setting Drug Substance and Drug Product Specifications 22. Validation of Analytical Methods for Biotechnology ProductsPART 6 PHARMACOPEIAL METHODS23. Pharmacopeial Methods and Test (Updated)PART 7 BIOLOGICAL FLUIDS24. Biological Fluids

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