Book description
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)Â-such as metered dose inhalers, dry powder inhalers,
and nasal spraysÂ-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:
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Guidance for pharmaceutical professionals to qualify and
risk-assess container closure system leachables and extractables
in drug products
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Principles for defining toxicological safety thresholds that
are applicable to OINDP and potentially applicable to other drug
products
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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.
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-year
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 Extractables Working Groups and is a member of the
ELSIE Board of Directors. Dr. Stults is a thirty-three year member of
the ACS.
LEE M. NAGAO is a Senior Science Advisor in the Pharmaceutical
Practice Group at Drinker Biddle & Reath LLP. As a member of the
IPAC-RS Secretariat, Dr. Nagao supports the Consortium's initiatives
in materials quality, leachables and extractables, supplier quality,
and foreign particles. She was a member of the PQRI OINDP Leachables
and Extractables Working Group and serves as Science Advisor and
Secretariat to the ELSIE Consortium. Dr. Nagao is a member of the ACS
and the AAAS.
