Leachables and Extractables Handbook : Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products.
Başlık:
Leachables and Extractables Handbook : Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products.
Yazar:
Ball, Douglas J.
ISBN:
9781118147702
Yazar Ek Girişi:
Basım Bilgisi:
1st ed.
Fiziksel Tanımlama:
1 online resource (701 pages)
İçerik:
LEACHABLES AND EXTRACTABLES HANDBOOK -- ROBERT KROES: IN MEMORIAM -- CONTENTS -- PREFACE -- ACKNOWLEDGMENTS -- CONTRIBUTORS -- PART I: DEVELOPMENT OF SAFETY THRESHOLDS, SAFETY EVALUATION, AND QUALIFICATION OF EXTRACTABLES AND LEACHABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS -- CHAPTER 1: OVERVIEW OF LEACHABLES AND EXTRACTABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS -- CHAPTER 2: A GENERAL OVERVIEW OF THE SUITABILITY FOR INTENDED USE REQUIREMENTS FOR MATERIALS USED IN PHARMACEUTICAL SYSTEMS -- CHAPTER 3: CONCEPT AND APPLICATION OF SAFETY THRESHOLDS IN DRUG DEVELOPMENT -- CHAPTER 4: THE DEVELOPMENT OF SAFETY THRESHOLDS FOR LEACHABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS -- CHAPTER 5: THE ANALYTICAL EVALUATION THRESHOLD (AET) AND ITS RELATIONSHIP TO SAFETY THRESHOLDS -- CHAPTER 6: SAFETY THRESHOLDS IN THE PHARMACEUTICAL DEVELOPMENT PROCESS FOR OINDP: AN INDUSTRY PERSPECTIVE -- CHAPTER 7: THE CHEMISTRY AND TOXICOLOGY PARTNERSHIP: EXTRACTABLES AND LEACHABLES INFORMATION SHARING AMONG THE CHEMISTS AND TOXICOLOGISTS -- CHAPTER 8: USE OF SAFETY THRESHOLDS IN THE PHARMACEUTICAL DEVELOPMENT PROCESS FOR OINDP: U.S. REGULATORY PERSPECTIVES -- CHAPTER 9: THE APPLICATION OF THE SAFETY THRESHOLDS TO QUALIFY LEACHABLES FROM PLASTIC CONTAINER CLOSURE SYSTEMS INTENDED FOR PHARMACEUTICAL PRODUCTS: A REGULATORY PERSPECTIVE -- PART II: BEST PRACTICES FOR EVALUATION AND MANAGEMENT OF EXTRACTABLES AND LEACHABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS -- CHAPTER 10: ANALYTICAL BEST PRACTICES FOR THE EVALUATION AND MANAGEMENT OF EXTRACTABLES AND LEACHABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS -- CHAPTER 11: CHEMICAL AND PHYSICAL ATTRIBUTES OF PLASTICS AND ELASTOMERS: IMPACT ON THE EXTRACTABLES PROFILE OF CONTAINER CLOSURE SYSTEMS -- CHAPTER 12: PHARMACEUTICAL CONTAINER CLOSURE SYSTEMS: SELECTION AND QUALIFICATION OF MATERIALS.
CHAPTER 13: ANALYTICAL TECHNIQUES FOR IDENTIFICATION AND QUANTITATION OF EXTRACTABLES AND LEACHABLES -- CHAPTER 14: EXTRACTABLES: THE CONTROLLED EXTRACTION STUDY -- CHAPTER 15: EXTRACTABLES: CASE STUDY OF A SULFUR-CURED ELASTOMER -- CHAPTER 16: CASE STUDY OF A POLYPROPYLENE: EXTRACTABLES CHARACTERIZATION, QUANTITATION, AND CONTROL -- CHAPTER 17: ANALYTICAL LEACHABLES STUDIES -- CHAPTER 18: DEVELOPMENT, OPTIMIZATION, AND VALIDATION OF METHODS FOR ROUTINE TESTING -- CHAPTER 19: CRITICAL COMPONENT QUALITY CONTROL AND SPECIFICATION STRATEGIES -- CHAPTER 20: INORGANIC LEACHABLES -- CHAPTER 21: FOREIGN PARTICULATE MATTER: CHARACTERIZATION AND CONTROL IN A QUALITY-BY-DESIGN ENVIRONMENT -- APPENDIXES -- APPENDIX 1: EXPERIMENTAL PROTOCOL FOR CONTROLLED EXTRACTION STUDIES ON ELASTOMERIC TEST ARTICLES -- APPENDIX 2: EXPERIMENTAL PROTOCOL FOR CONTROLLED EXTRACTION STUDIES ON PLASTIC TEST ARTICLES -- APPENDIX 3: PROTOCOL ADDITION, PHASE 2 STUDIES: QUANTITATIVE CONTROLLED EXTRACTION STUDIES ON THE SULFUR-CURED ELASTOMER -- APPENDIX 4: PROTOCOL ADDITION, PHASE 2 STUDIES: QUANTITATIVE EXTRACTABLES STUDIES ON SULFUR-CURED ELASTOMER AND POLYPROPYLENE -- INDEX.
Özet:
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)-such as metered dose inhalers, dry powder inhalers, and nasal sprays-pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Notlar:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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