Pharmaceutical Dosage Forms - Parenteral Medications (PDF)
Volume 3: Regulations, Validation and the Future
(Sprache: Englisch)
Regulations, Validation and the Future is the third volume in the Pharmaceutical Dosage Forms- Parenteral Medications three-volume set. The book presents an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation,...
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Regulations, Validation and the Future is the third volume in the Pharmaceutical Dosage Forms- Parenteral Medications three-volume set. The book presents an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. New chapters cover recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), as well as validation of drug product manufacturing process.
Autoren-Porträt
Sandeep Nema Ph.D. is Executive Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis. Since graduating in 1992 with his doctorate, Dr. Nema has been involved with the development of small molecule and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia), and has led the formulation of four launched products. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA), where he has chaired several meetings and focus groups. Dr. Nema holds an adjunct faculty appointment at the University of Tennessee.John D. Ludwig Ph.D. is Vice President, Business Strategy, Operations, and Clinical Supply Planning, BioTherapeutics Pharmaceutical Sciences at Pfizer, and Site Director for the company's St. Louis Laboratories. Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle, Inc., Pharmacia, Inc., and Pfizer. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute, where he has contributed to developing professional training courses and has regularly served as an instructor.
Bibliographische Angaben
- 2016, 3. Auflage, 318 Seiten, Englisch
- Herausgegeben: Sandeep Nema, John D. Ludwig
- Verlag: Taylor & Francis
- ISBN-10: 1420086480
- ISBN-13: 9781420086485
- Erscheinungsdatum: 19.04.2016
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