Dennis Jenke's Books

Extractables and Leachables

Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices

By: Dennis Jenke

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Extractables and Leachables

Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices

By: Dennis Jenke

EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.

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Page Count

468

Publisher

John Wiley & Sons

Published Date

ISBN 10

1119605105

ISBN 13

9781119605102

Compatibility of Pharmaceutical Solutions and Contact Materials

Safety Assessments of Extractables and Leachables for Pharmaceutical Products

By: Dennis Jenke

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Compatibility of Pharmaceutical Solutions and Contact Materials

Safety Assessments of Extractables and Leachables for Pharmaceutical Products

By: Dennis Jenke

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.

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Page Count

400

Publisher

John Wiley & Sons

Published Date

ISBN 10

1118679474

ISBN 13

9781118679470

Compatibility of Pharmaceutical Solutions and Contact Materials

Safety Assessments of Extractables and Leachables for Pharmaceutical Products

By: Dennis Jenke

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Compatibility of Pharmaceutical Solutions and Contact Materials

Safety Assessments of Extractables and Leachables for Pharmaceutical Products

By: Dennis Jenke

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Page Count

400

Publisher

John Wiley & Sons

Published Date

ISBN 10

1118679474

ISBN 13

9781118679470

Europe's Red Terrorists

The Fighting Communist Organizations

By: Yonah Alexander,Dennis A. Pluchinsky

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Europe's Red Terrorists

The Fighting Communist Organizations

By: Yonah Alexander,Dennis A. Pluchinsky

This unique volume explores Europe's most dangerous communist terrorist organizations and reveals how they use violence as a means of political communication and persuasion. It outlines seven terrorist groups from Germany, Greece, Spain, France, Belgium, Italy and Turkey and gives their modus operandi, rationale and political messages in translated communiqués never before available in English.

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Page Count

273

Publisher

Routledge

Published Date

ISBN 10

1136294139

ISBN 13

9781136294136

Quantitative Investment Analysis

By: Richard A. DeFusco,Dennis W. McLeavey,Jerald E. Pinto,David E. Runkle,Mark J. P. Anson

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Quantitative Investment Analysis

By: Richard A. DeFusco,Dennis W. McLeavey,Jerald E. Pinto,David E. Runkle,Mark J. P. Anson

Your complete guide to quantitative analysis in the investment industry Quantitative Investment Analysis, Third Edition is a newly revised and updated text that presents you with a blend of theory and practice materials to guide you through the use of statistics within the context of finance and investment. With equal focus on theoretical concepts and their practical applications, this approachable resource offers features, such as learning outcome statements, that are targeted at helping you understand, retain, and apply the information you have learned. Throughout the text's chapters, you explore a wide range of topics, such as the time value of money, discounted cash flow applications, common probability distributions, sampling and estimation, hypothesis testing, and correlation and regression. Applying quantitative analysis to the investment process is an important task for investment pros and students. A reference that provides even subject matter treatment, consistent mathematical notation, and continuity in topic coverage will make the learning process easier—and will bolster your success. Explore the materials you need to apply quantitative analysis to finance and investment data—even if you have no previous knowledge of this subject area Access updated content that offers insight into the latest topics relevant to the field Consider a wide range of subject areas within the text, including chapters on multiple regression, issues in regression analysis, time-series analysis, and portfolio concepts Leverage supplemental materials, including the companion Workbook and Instructor's Manual, sold separately Quantitative Investment Analysis, Third Edition is a fundamental resource that covers the wide range of quantitative methods you need to know in order to apply quantitative analysis to the investment process.

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