Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product-Reference-Cited by-同舟云学术

Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product

Published:2009 Issue: Volume: Page:241-261
ISSN:
Container-title:Handbook of Stability Testing in Pharmaceutical Development
language:
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Author:

Guo Yushen

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-0-387-85627-8_12.pdf

Reference71 articles.

1. Tingstad JE (1964) Physical stability testing of pharmaceuticals. J Pharm Sci 53:955–962.

2. Perlia X (1967) Stability and stabilization of drugs. II. Physical viewpoints. Pharm Acta Helv 42:265–302.

3. ICH Guideline Q6A (1999) Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.

4. ICH Guideline Q1A (2001) Stability Testing of New Drug Substance and Products.

5. Pearlman R, Wang YJ (1996) Formulation, Characterization, and Stability of Protein Drugs: Case Histories. Plenum Publishing Corporation, New York.

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