原薬・製剤の規格：分析手法の開発とバリデーション（第２版） Specification of Drug Substances and Products : Development and Validation of Analytical Methods （2ND）

Riley, Christopher M. (EDT)/ Rosanske, Thomas W. (EDT)/ Reid, George L. (EDT)

Elsevier / The Lancet（2020/07発売）

• 製本 Paperback:紙装版/ペーパーバック版／ページ数 694 p.
• 言語 ENG
• 商品コード 9780081028247
• DDC分類 615.1

Full 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.

Contents

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