Leachables and Extractables Handbook

Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

Nonfiction, Science & Nature, Science, Chemistry, Technical & Industrial
Cover of the book Leachables and Extractables Handbook by , Wiley
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9781118147689
Publisher: Wiley Publication: February 8, 2012
Imprint: Wiley Language: English
Author:
ISBN: 9781118147689
Publisher: Wiley
Publication: February 8, 2012
Imprint: Wiley
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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:

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.

More books from Wiley

Cover of the book AutoCAD 2010 and AutoCAD LT 2010 Bible by
Cover of the book Electric Power Principles by
Cover of the book Functional and Physical Properties of Polymer Nanocomposites by
Cover of the book What Makes Life Worth Living by
Cover of the book A Companion to Theodore Roosevelt by
Cover of the book Fischer Black and the Revolutionary Idea of Finance by
Cover of the book Fraud Auditing and Forensic Accounting by
Cover of the book Non-Neoplastic Hematopathology and Infections by
Cover of the book Dietary Nutrients, Additives and Fish Health by
Cover of the book $700 Billion Bailout by
Cover of the book A Dictionary of Cultural and Critical Theory by
Cover of the book Bailout Nation by
Cover of the book Applied Survival Analysis by
Cover of the book The Electronic Eye by
Cover of the book Golf's Short Game For Dummies by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy