International stability testing. (2020)

• Record Type: Book
• Further Information: Note: Edited by David J. Mazzo.
• Other Names: Mazzo, David J
• Contents: ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.
• Publisher Details: Place of publication not identified : CRC Press
• Publication Date: 2020
• Extent: 1 online resource (352 pages)
• Subjects: 615/.18; Drug stability -- Standards; Drug Stability; Drug Approval; Guidelines as Topic; Pharmaceutical Preparations -- analysis; Pharmaceutical Preparations -- standards
• Languages: English
• ISBNs: 9781000161663; 1000161668
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.