Specification of Drug Substances and Products

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书名：Specification of Drug Substances and Products -Development and Validation of Analytical Methods
作者： Christopher M. Riley, Thomas W. Rosanske and Shelley R. Rabel Riley
出版社：Elsevier Ltd.
出版日期：23 Oct 2013
eBook ISBN :9780080983431
Print Book ISBN :9780080983509
页数：390页 |
格式：清晰PDF+ 可复制
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文件大小：6.87MB
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封面：


目录
Part One: Basic Concepts and Definitions
Introduction
General Principles and Regulatory Considerations: Specifications
Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
General Principles and Regulatory Considerations: Method Validation
Part Two: Universal Tests
Description and Identification
Assay, and Impurities
Residual Solvents
Inorganic Impurities (Heavy Metals)
Part Three: Specific Tests: Drug Substances
Solid-State Characterization
Chiral Methods
Water Determination
Part Four: Specific Tests: Drug Products
Dissolution and Disintegration
Extractables and Leachables
Potency Assays for Biomolecules
Host Cell Protein Assays
Part Five: Pharmacopeial Methods
Pharmacopeial Methods and Tests
Part Six: Microbial Methods
Sterile and Non-Sterile Products
Part Seven: Biological Fluids
Biological Fluids