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

Because leachables are non-drug-related impurities, there is an increased concern for human risk by inhaling them on a daily basis. Recently, however, safety thresholds for leachables have been developed by the FDA, academia, and industry. This book addresses concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables in Orally Inhaled and Nasal Drug Products (OINDP). Coverage includes the FDA and EU regulatory perspectives concerning leachables in OINDP. While written specifically for OINDP, the principles outlined can be applied to leachables qualification in other drug products.

Douglas J. Ball is a board-certified toxicologist (Diplomate of the American Board of Toxicology) and currently employed by Pfizer Inc. as a Research Fellow in drug safety R D specializing in regulatory strategy and compliance. He chairs the Extractables and Leachables Safety Information Exchange (ELSIE) Board of Directors, and the Toxicology Team of the Product Quality Research Institute (PQRI) leachables and Extractables Working Group for both OINDP and parenteral and ophthalmic drug products. Daniel L. Norwood is a Distinguished Research Fellow in Analytical Development at Boehringer Ingelheim and has more than thirty-five years of professional experience. He chaired the PQRI Leachables and Extractables Working Group and is a thirty-two-years member of the American Chemical Society (ACS). Dr. Norwood is a member of the ELSIE Board of Directors. Cheryl L. M. Stults is a Senior Fellow at Novartis Pharmaceuticals Corporation, focusing on materials analysis and characterization. She chairs the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Materials and Leachables and Ectractables Working Groups and is a member of the ELSIE Board of Directors. Dr. Stults is a thirty-three years member of the ACS. Lee M. Nagao is a Senior Advisor in the Pharmaceutical Practice Group at Drinker Biddle Reath LLP. As a member of the IPAC-RS Secretariat. Dr. Nagao supports the Consortiums initiatives in materials quality, leachables and ectractables, supplier quality, and foreign particles. She was a member of the PQRI OINDP Leachables and Ectractables Working Group and serves as Science Advisor and Secretariat to the ELSIE Consortium. D. Nagao is a member of the ACS and the AAAS.