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Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Editat de Christopher M. Riley, Thomas W. Rosanske, George L. Reid
en Limba Engleză Paperback – 24 iul 2020
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
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Specificații

ISBN-13: 9780081028247
ISBN-10: 0081028245
Pagini: 694
Ilustrații: 175 illustrations (15 in full color)
Dimensiuni: 191 x 235 mm
Greutate: 1.2 kg
Ediția:2
Editura: ELSEVIER SCIENCE

Public țintă

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

Cuprins

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