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Elsevier

Specification of Drug Substances and Products

Development and Validation of Analytical Methods

  • 2nd Edition - July 23, 2020
  • Newer edition is available
  • Editors: Christopher M. Riley, Thomas W. Rosanske, George L. Reid
  • Language: English

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requireme… Read more

Description

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.

Key features

  • 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

Readership

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

Table of contents

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

Product details

About the editors

CR

Christopher M. Riley

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.

Affiliations and expertise
President of Riley and Rabel Consulting Services, Maryville, MO, USA

TR

Thomas W. Rosanske

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.
Affiliations and expertise
Consultatnt, Lee's Summit, MO, USA

GR

George L. Reid

Affiliations and expertise
Principal Consultant, Cardinal Health, Kansas City, MO, USA

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