Specification of Drug Substances and Products: Development and Validation of Analytical Methods [2 ed.] 0081028245, 9780081028247
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, present
286 104 25MB
English Pages 712 [660] Year 2019
Table of contents :
Front-Matter_2020_Specification-of-Drug-Substances-and-Products
Specification of Drug Substances and ProductsDevelopment and Validation of Analytical MethodsSecond EditionEdited byChristo ...
Copyright_2020_Specification-of-Drug-Substances-and-Products
Copyright
Contributors_2020_Specification-of-Drug-Substances-and-Products
Contributors
Chapter-1---Introduction_2020_Specification-of-Drug-Substances-and-Products
1. Introduction
References
Chapter-2---General-principles-and-regulatory-con_2020_Specification-of-Drug
2. General principles and regulatory considerations: specifications and shelf life setting
2.1 Introduction
2.2 Regulatory requirements
2.2.1 International council on harmonization of the technical requirements for pharmaceuticals for human use
2.2.1.1 Universal tests
2.2.1.1.1 Description
2.2.1.1.2 Identification
2.2.1.1.3 Assay
2.2.1.1.4 Impurities
2.2.1.2 Specific tests
2.2.1.2.1 Drug substance
2.2.1.2.2 Drug product
2.2.2 Compendial requirements
2.2.2.1 Testing requirements
2.2.2.2 USP general chapters
Front-Matter_2020_Specification-of-Drug-Substances-and-Products
Specification of Drug Substances and ProductsDevelopment and Validation of Analytical MethodsSecond EditionEdited byChristo ...
Copyright_2020_Specification-of-Drug-Substances-and-Products
Copyright
Contributors_2020_Specification-of-Drug-Substances-and-Products
Contributors
Chapter-1---Introduction_2020_Specification-of-Drug-Substances-and-Products
1. Introduction
References
Chapter-2---General-principles-and-regulatory-con_2020_Specification-of-Drug
2. General principles and regulatory considerations: specifications and shelf life setting
2.1 Introduction
2.2 Regulatory requirements
2.2.1 International council on harmonization of the technical requirements for pharmaceuticals for human use
2.2.1.1 Universal tests
2.2.1.1.1 Description
2.2.1.1.2 Identification
2.2.1.1.3 Assay
2.2.1.1.4 Impurities
2.2.1.2 Specific tests
2.2.1.2.1 Drug substance
2.2.1.2.2 Drug product
2.2.2 Compendial requirements
2.2.2.1 Testing requirements
2.2.2.2 USP general chapters
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0081028245, 9780081028247](https://ebin.pub/img/200x200/specification-of-drug-substances-and-products-development-and-validation-of-analytical-methods-2nbsped-0081028245-9780081028247.jpg)
- Author / Uploaded
- Christopher M. Riley
- Thomas W. Rosanske
- George L. Reid
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