Table of Contents

Front Matter.
PART I, DEVELOPMENT OF SAFETY THRESHOLDS, SAFETY EVALUATION, AND QUALIFICATION OF EXTRACTABLES AND LEACHABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS. Overview of leachables and extractables in orally inhaled and nasal drug products / Douglas J. Ball, Daniel L. Norwood, and Lee M. Nagao.
A general overview of the suitability for intended use requirements for materials used in pharmaceutical systems / Dennis Jenke.
Concept and application of safety thresholds in drug development / David Jacobson-Kram and Ronald D. Snyder.
The development of safety thresholds for leachables in orally inhaled and nasal drug products / W. Mark Vogel.
The analytical evaluation threshold (AET) and its relationship to safety thresholds / Daniel L. Norwood, James O. Mullis, and Scott J. Pennino.
Safety thresholds in the pharmaceutical development process for oindp: an industry perspective / David Alexander and James Blanchard.
The chemistry and toxicology partnership: extractables and leachables information sharing among the chemists and toxicologists / Cheryl L.M. Stults, Ronald Wolff, and Douglas J. Ball.
Use of safety thresholds in the pharmaceutical development process for oindp: u.s. regulatory perspectives / Timothy J. McGovern.
The application of the safety thresholds to qualify leachables from plastic container closure systems intended for pharmaceutical products: a regulatory perspective / Kumudini Nicholas.
PART II, BEST PRACTICES FOR EVALUATION AND MANAGEMENT OF EXTRACTABLES AND LEACHABLES IN ORALLY INHALED AND NASAL DRUG PRODUCTS. Analytical best practices for the evaluation and management of extractables and leachables in orally inhaled and nasal drug products / Daniel L. Norwood, Cheryl L.M. Stults, and Lee M. Nagao.
Chemical and physical attributes of plastics and elastomers: impact on the extractables profile of container closure systems / Michael A. Ruberto, Diane Paskiet, and Kimberly Miller.
Pharmaceutical container closure systems: selection and qualification of materials / Douglas J. Ball, William P. Beierschmitt, and Arthur J. Shaw.
Analytical techniques for identification and quantitation of extractables and leachables / Daniel L. Norwood, Thomas N. Feinberg, James O. Mullis, and Scott J. Pennino --Extractables: the controlled extraction study / Thomas N. Feinberg, Daniel L. Norwood, Alice T. Granger, and Dennis Jenke.
Extractables: case study of a sulfur-cured elastomer / Daniel L. Norwood, Fenghe Qiu, James R. Coleman, James O. Mullis, Alice T. Granger, Keith McKellop, Michelle Raikes, and John A. Robson.
Case study of a polypropylene: extractables characterization, quantitation, and control / Diane Paskiet, Laura Stubbs, and Alan D. Hendricker.
Analytical leachables studies / Andrew D. Feilden and Andy Rignall.
Development, optimization, and validation of methods for routine testing / Cheryl L.M. Stults and Jason M. Creasey.
Critical component quality control and specification strategies / Terrence Tougas, Suzette Roan, and Barbara Falco.
Inorganic leachables / Diane Paskiet, Ernest L. Lippert, Brian D. Mitchell, and Diego Zurbriggen.
Foreign particulate matter: characterization and control in a quality-by-design environment / James R. Coleman, John A. Robson, John A. Smoliga, and Cornelia B. Field.
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. A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug productsPackaging 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.
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug productsPackaging 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.
Ball, Douglas J;Nagao, Lee M;Norwood, Daniel L;Stults, Cheryl L. M
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John Wiley & Sons
2011
9781118147672
9780470173657
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