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Compatibility of Pharmaceutical Solutions and Contact Materials

Safety Assessments of Extractables and Leachables for Pharmaceutical Products

Dennis Jenke

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John Wiley & Sons img Link Publisher

Naturwissenschaften, Medizin, Informatik, Technik / Chemie


Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: * Pertinent regulations and practical ways to meet guidelines * Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development * Materials characterization and the materials screening process * Component and/or system qualification (illustrated by several case studies) * Performing validation/migration studies and interpreting and reporting the results * Creating a product registration dossier and putting it through regulatory review * Product maintenance (Change Control) from an extractables and leachables perspective * Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.


(BTS Newsletter, Summer2010)
"The book provides a very detailed review of approaches forgenerating and further investigating extractables and leachablesresults, with advice on the levels of investigation appropriate toeach stage of product development."
--Diane M. Paskiet, AssociateDirector of Scientific Affairs, West Pharmaceutical Services
"The analogy of extractables and leachables to the bogeyman hidingin the closet is so true and telling, whether experienced withleachable studies or not the issues are well communicated.Nomenclature is established, in the author?s vernacular, whichdescribes pharmaceutical contact materials and key terms enabling aclear understanding of the objectives of compatibility assessments.Excellent examples of extractables studies, correlations and riskassessments are given and the classification of extractionstrategies puts into perspective the purpose for acquiring thedata. The appendix listing materials and their associatedextractables is a valuable reference tool for chemists,toxicologists and regulators involved with qualifying contactmaterials used with pharmaceutical products. This is acomprehensive and practical guide for both the novice and theknowledgeable. A great read!"
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Chemie, Drug Discovery & Development, Arzneimittelforschung, Analytische Chemie, Toxicology, Chemistry, Toxikologie, Analytical Chemistry, Wirkstoffforschung u. -entwicklung