Specification of Drug Substances and Products

Development and Validation of Analytical Methods
2. Auflage 2020
ISBN: 978-0-08-102824-7
Verlag: Elsevier Science & Technology

Buch, Englisch, 694 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 1540 g

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.

Zielgruppe

Primary: Scientists, managers, educators and consultants involved in the development and regulation of pharmaceutical products, especially those concerned with the Chemistry, Manufacturing and Controls (CMC) aspects of drug development. This includes analytical chemists, preformulation scientists, formulation scientists, process chemists, process engineers, and pharmaceutical microbiologists, as well as those involved in regulatory affairs, quality control and quality assurance.Secondary: academic researchers involved in drug research and development, particularly those who collaborate with industry or serve as consultants; faculty and students pursuing post-graduate degrees in Pharmaceutical Analysis, Pharmaceutics or Pharmaceutical Chemistry and certificates in Regulatory Affairs or Quality Assurance

Autoren/Hrsg.

Riley, Christopher M.

Rosanske, Thomas W.

Reid, George L.

Fachgebiete

• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie

Inhaltsverzeichnis

PART 1 INTRODUCTION 1. 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 Technology

PART 2 UNIVERSAL TESTS 8. 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 SUBSTANCES 15. Solid State Characterization 16. Chiral Methods 17. Water Determination

PART 4 SPECIFIC TESTS DRUG PRODUCT 18. Drug Release: Oral Products 19. Topical Products 20. Extractables and Leachables

PART 5 BIOTECHNOLOGY PRODUCTS 21. Regulatory Requirements for Setting Drug Substance and Drug Product Specifications  22. Validation of Analytical Methods for Biotechnology Products

PART 6 PHARMACOPEIAL METHODS 23. Pharmacopeial Methods and Test (Updated)

PART 7 BIOLOGICAL FLUIDS 24. Biological Fluids

Über Autor(innen)

Riley, Christopher M.
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.

Rosanske, Thomas W.
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.