Read online: Extractables and Leachables:

Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices. Dennis Jenke

Extractables-and-Leachables.pdf
ISBN: 9781119605072 | 448 pages | 12 Mb

• Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices
• Dennis Jenke
• Page: 448
• Format: pdf, ePub, fb2, mobi
• ISBN: 9781119605072
• Publisher: Wiley

Download Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices

Ebook forum rapidshare download Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices 9781119605072 ePub PDF

Overview

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.

More eBooks:
Download Pdf Six Walks: In the Footsteps of Henry David Thoreau by Ben Shattuck
[Kindle] L'installation électrique en fiches pratiques download
[PDF/Kindle] LA MUERTE EN VENECIA descargar gratis
{pdf descargar} EL ESPIRITU DEL LINCE
The Lady of the Lake by Andrzej Sapkowski, David French, Andrzej Sapkowski, David French on Ipad
[PDF] Max et Lili ont des copains réfugiés download
[Descargar pdf] EL CAMINO DEL FUEGO
Download Pdf L'italien pour les nuls
Read online: The New Breed: What Our History with Animals Reveals about Our Future with Robots by Kate Darling
Download Pdf The Chaos Agents by F. Fox North, F. Fox North
Online Read Ebook Le guide de survie des hypersensibles empathiques
{epub download} Pressure Canning for Beginners and Beyond: Safe, Easy Recipes for Preserving Tomatoes, Vegetables, Beans and Meat by