Title Statements
- Full title :ICH Quality Guidelines : an Implementation Guide.
Edition Statements
- Publication Date:2017.
Publication Statements
- Publisher(s):John Wiley & Sons, Incorporated
- Place of Publication:Somerset
- Language:eng
- Publication Date:2017.
Notes
""4.2.6 Stability Protocols for Quantifying the Effects of Temperature and Humidity""
The Physical Object
- Description:1 online resource (736 pages)
Edition Identifiers
- ISBN:9781118971123, 1118971124
- oclc:on1005611096
- Dewey Decimal:615.19
Table of Contents
Title Page -- Copyright Page -- Contents -- List of Contributors -- An Introduction to ICH Quality Guidelines: Opportunities and Challenges -- References -- Chapter 1 ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms -- 1.1 Introduction -- 1.2 The Fundamental Science That Underpins Stability Testing -- 1.2.1 The Stability Process -- 1.2.2 Factors Affecting Stability -- 1.2.3 The Fundamental Science That Underpins Stability Testing: Summary
1.3 Part II: Practical Application of the ICH Stability Guidance1.3.1 General Considerations -- 1.3.2 Drug Substance Stability -- 1.3.3 Drug Product -- 1.3.4 Conclusions -- References -- Chapter 2 Stability Testing: Photostability Testing of New Drug Substances and Products ICH Q1B -- 2.1 Introduction -- 2.2 What the Guidance Says -- 2.3 What the Guidance Does Not Say -- Question 1. Are the ICH Tests All I Need to Do? -- Question 2. What Is Acceptable Change? -- Question 3. How Do I Provide the Required Level of Light?
Question 4. How Do I Know if I Have Provided the Right Amount of Light?Question 5. In What Form Should I Present My Sample? -- Question 6: I…
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