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Overview
Here’s the complete overview of Mutagenic Impurities: Strategies for Identification and Control 1st Edition PDF:
In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective.
The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment.
The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination.
Features of Mutagenic Impurities: Strategies for Identification and Control 1st Edition PDF
Here’s a quick overview of the essential features of this book:
- A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline
- An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities
- A discussion of a toxicological perspective on mutagenic impurities, including th
Table of Contents
Below is the complete table of contents offered inside Mutagenic Impurities: Strategies for Identification and Control 1st Edition PDF:
- 1.1 Introduction
- 1.1.1 CPMP – Position Paper on the Limits of Genotoxic Impurities –2002
- 1.1.1.1 Scope/Introduction
- 1.1.1.2 Toxicological Background
- 1.1.1.3 Pharmaceutical (Quality) Assessment
- 1.1.1.4 Toxicological Assessment
- 1.1.2 Guideline on the Limits of Genotoxic Impurities – Draft June 2004
- 1.1.3 PhRMA (Mueller) White Paper
- 1.1.4 Finalized EMA Guideline on the Limits of Genotoxic Impurities – June 2006
- 1.1.4.1 Issues Associated with Implementation
- 1.1.4.2 Control Expectations for Excipients
- 1.1.4.3 Control Expectations for Natural/Herbal Products
- 1.1.4.4 Identification of Potential Impurities
- 1.1.4.5 The Principle of Avoidance
- 1.1.4.6 The ALARP Principle
- 1.1.4.7 Overall
- 1.1.5 SWP Q&A Document
- 1.1.5.1 The Application of the Guideline in the Investigational Phase and Acceptable Limits for GIs Where Applied to Studies of Limited Duration
- 1.1.5.2 Application of the Guideline to Existing Products
- 1.1.5.3 Avoidance and ALARP
- 1.1.5.4 ICH Identification Threshold and its Relation to MI Assessment
- 1.1.6 FDA Draft Guideline
- 1.1.7 Other Relevant Guidance
- 1.1.7.1 Excipients
- 1.1.8 Herbals
- 1.1.9 ICH S9
- 1.1.10 Conclusions
- References
Chapter 2: ICH M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
- 2.1 Introduction
- 2.2 ICH M7
- 2.2.1 Introduction
- 2.2.2 Scope
- 2.2.2.1 Established Products
- 2.2.2.2 Anticancer Treatments
- 2.2.2.3 Nature of Therapeutic Agent/Excipients
- 2.2.3 General Principles
- 2.2.4 Considerations for Marketed Products
- 2.2.4.1 Post-approval Changes to Drug Substance, Chemistry, and Manufacturing Controls
- 2.2.4.2 Post-approval Changes to Drug Product Chemistry, Manufacturing, and Controls
- 2.2.4.3 Changes to the Clinical Use of Drug Products
- 2.2.5 Other Considerations for Marketed Products
- 2.2.6 Drug Substance and Drug Product Impurity Assessment
- 2.2.6.1 Synthetic Impurities
- 2.2.6.2 Degradation Products
- 2.2.7 Hazard Assessment
- 2.2.8 Risk Characterization
-
- – 2.2.8.1 Threshold of Toxicological Concern (TTC) and Comparison to Exposure Limits – 2.2.8.2 Margin of Safety (MoS) – 2.2.8.3 Acceptable Intake (AI)
- 2.2.9 Control Strategies
- 2.2.9.1 Permitted Daily Exposure (PDE)
- 2.2.9.2 Control Strategy for Elemental Impurities
- 2.2.10 Genotoxicity Testing
- 2.2.10.1 In Silico Analysis
- 2.2.10.2 In Vitro Assays
- 2.2.10.3 In Vivo Assays
- 2.2.11 Experience and Case Studies
- 2.2.11.1 Case Study 1: Impurities Generated During Manufacturing Process
- 2.2.11.2 Case Study 2: Potential Impurities in Starting Materials
- 2.2.11.3 Case Study 3: Impurities Formed During Storage
- 2.2.11.4 Case Study 4: Impurities from Degradation Products
- 2.2.11.5 Case Study 5: Impurities from Reaction By-products
- 2.2.12 Labelling and Reporting
- 2.2.13 Conclusion
- 2.2.9 Control Strategies
- References
Chapter 3: Implementation of ICH M7: Challenges and Solutions
- 3.1 Introduction
- 3.2 Challenges in Implementing ICH M7
- 3.2.1 Availability of Data and Information
- 3.2.2 Applicability to Complex Molecules and New Modalities
- 3.2.3 Selection of Relevant Ames Assay Strains
- 3.2.4 In Silico Tools and Predictive Models
- 3.2.5 Setting Appropriate Permitted Daily Exposures (PDEs)
- 3.2.6 Genotoxicity Testing Strategy
- 3.2.7 Communication and Collaboration with Regulators
- 3.3 Solutions and Strategies
- 3.3.1 Data Sharing and Collaboration
- 3.3.2 Development of New Testing Approaches
- 3.3.3 Refinement of In Silico Tools and Predictive Models
- 3.3.4 Harmonization of PDE Calculation Methodologies
- 3.3.5 Regulatory Engagement and Communication
- 3.4 Case Studies and Examples
- 3.5 Future Perspectives
- References
Chapter 4: Emerging Trends and Future Directions in the Assessment of Genotoxic Impurities
- 4.1 Introduction
- 4.2 Advances in Genotoxicity Testing
- 4.2.1 High-Throughput Screening (HTS) Assays
- 4.2.2 In Vitro Micronucleus Assay
- 4.2.3 In Vivo Micronucleus Assay
- 4.2.4 New and Alternative Assays
- 4.3 Integration of Genotoxicity Assessment into Early Drug Development
- 4.3.1 Early Predictive Toxicology
- 4.3.2 In Silico Approaches
- 4.3.3 High-Content Screening
-
- 4.4 Genotoxicity Assessment for New Modalities
- 4.4.1 Antibody-Drug Conjugates (ADCs)
- 4.4.2 Gene and Cell Therapies
- 4.4.3 Oligonucleotide-Based Therapies
- 4.5 Risk-Based Approaches
- 4.5.1 Thresholds and Safe Harbor Concepts
- 4.5.2 In-Use Stability Testing
- 4.5.3 Extractables and Leachables
- 4.6 Regulatory Perspectives and Guidelines
- 4.7 Future Directions and Challenges
- 4.7.1 Advancements in Predictive Models and Tools
- 4.7.2 Integration of Genotoxicity Assessment with other Safety Assessments
- 4.7.3 Addressing Challenges in Non-Genotoxic Carcinogens
- 4.7.4 Emerging Technologies and Techniques
- 4.7.5 Regulatory Harmonization and Global Alignment
- References
Chapter 5: Case Studies and Practical Considerations in Genotoxic Impurity Assessment
- 5.1 Introduction
- 5.2 Case Study 1: Development and Control of Genotoxic Impurities in Small Molecule Drug Substance
- 5.3 Case Study 2: Genotoxic Impurities in Drug Product and Excipients
- 5.4 Case Study 3: Genotoxicity Assessment for Biologics and Biotechnology-Derived Products
- 5.5 Case Study 4: Genotoxicity Assessment for Extractables and Leachables
- 5.6 Case Study 5: Genotoxic Impurities in Combination Products
- 5.7 Case Study 6: Genotoxicity Testing for New Modalities
- 5.8 Practical Considerations and Best Practices
- References
Chapter 6: Conclusion
- 6.1 Summary of Key Findings
- 6.2 Implications and Importance of Genotoxic Impurity Assessment
- 6.3 Future Directions and Areas for Further Research
- 6.4 Closing Remarks
Appendix A: Glossary of Terms
Appendix B: Abbreviations and Acronyms
Appendix C: List of ICH Guidelines
Appendix D: Regulatory Agencies and Resources
Appendix E: Useful Online Tools and Databases
Index
- 4.4 Genotoxicity Assessment for New Modalities
- – 2.2.8.1 Threshold of Toxicological Concern (TTC) and Comparison to Exposure Limits – 2.2.8.2 Margin of Safety (MoS) – 2.2.8.3 Acceptable Intake (AI)
Mutagenic Impurities: Strategies for Identification and Control 1st Edition PDF Free Download
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