| Description |
1 online resource |
|
text txt rdacontent |
|
computer c rdamedia |
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online resource cr rdacarrier |
| Note |
Online resource; title from digital title page (viewed on August 10, 2020). |
| Summary |
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. |
| Subject |
Drugs -- Standards.
|
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Drug development.
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Pharmaceutical Preparations -- standards |
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Drug Development |
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Médicaments -- Normes.
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Médicaments -- Développement.
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Drug development
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Drugs -- Standards
|
| Added Author |
Riley, Christopher M., editor.
|
|
Rosanske, Thomas W., editor.
|
|
Reid, George L., editor.
|
| Other Form: |
Print version: 0081028245 9780081028247 (OCoLC)1082966081 |
| ISBN |
0081028253 (electronic book) |
|
9780081028247 (electronic bk.) |
|
0081028245 (electronic bk.) |
|
9780081028254 (electronic bk.) |
| Standard No. |
AU@ 000067742990 |
|
