Specification of Drug Substances and Products

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

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. Includes analytical chemists, pre-formulation scientists, formulation scientists, process chemists, process engineers, and pharmaceutical microbiologists as well as those involved in regulatory affairs, quality control and quality assurance. 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

PART 1 INTRODUCTION
1. Introduction
C. Riley, T. Rosanske and G. Reid
2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting
C. Riley and H. Yang
3. General Principles and Regulatory Considerations: Method Development and Validation
T. Rosanske
4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
D. Lloyd, J. Bergum and Q. Wang
5. Analytical Methods in the Clinical Phase of Development
J. Orr and G. Reid
6. Method Transfer
G. Reid
7. Process Analytical Technology
I. Clegg

PART 2 UNIVERSAL TESTS
8. Description and Identification
E. Parente
9. Assay and Impurities: Specifications
E. Kikovska-Stojanovska, C. Riley, A. Clarke, and R. Phelps
10. Assay and Impurities: Method Development and Life-Cycle Management
A. Clarke, C. Riley,and E. Kikovska-Stojanovska
11. Assay and Impurities: Method Validation
C. Riley, A. Clarke, E. Kikovska-Stojanovska
12. Mutagenic Impurities
S. Baerschi and B. Olsen
13. Residual Solvents
G. Reid
14. Inorganic Impurities (Elemental Impurities)
E. Parente

PART 3 SPECIFIC TESTS: DRUG SUBSTANCES
15. Solid State Characterization
P. Tishmack, P. Smith, and P. Chen
16. Chiral Methods
B. He and D. Lloyd
17. Water Determination
D. Armstrong and M. Talebi

PART 4 SPECIFIC TESTS DRUG PRODUCT
18. Drug Release: Oral Products
V. Gray and T. Rosanske
19. Topical Products
K. Thakker and R. Klein
20. Extractables and Leachables
K. Moyer and J. Scull

PART 5 BIOTECHNOLOGY PRODUCTS
21..Regulatory Requirements for Setting Drug Substance and Drug Product Specifications
K. Amsberry and Y.H. Lai
22. Validation of Analytical Methods for Biotechnology Products
J. Dally and M, Monck

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

PART 7 BIOLOGICAL FLUIDS
24. Biological Fluids
L. Yuan, L. Wang, L. Pan, Q. Ji