Buch, Englisch, 904 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 1436 g
An International
Buch, Englisch, 904 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 1436 g
Reihe: Drugs and the Pharmaceutical Sciences
ISBN: 978-0-8247-0838-2
Verlag: CRC Press
Zielgruppe
Academic, Professional, and Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
- Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Kosmetische Technologie
Weitere Infos & Material
Regulatory basis for process validation, John M. Dietrick and Bernard T. Loftus; prospective process validation, Allen Y. Chao, F. St Forbes, and Reginald F. Johnson; retrospective process validation, Chester J. Trubinski; sterilization validation, Michael J. Akers and Neil R. Anderson; validation of solid dosage forms, Jeffrey S. Rudolph and Robert J. Sepeljak; validation of medical devices, Toshiaki Nishihata; validation of biotechnology processes, Gail Sofer; transdermal process validation, Charlie Neal, Jr; validation of lyophilized products, Edward H. Trappler; validation of inhalation of aerosols, Chris Sciarra and John Sciarra; process validation of pharmaceutical ingredients, Robert A. Nash; qualification of water and air handling systems, Kunio Kawamura; equipment and facility qualification, Tom Peither; validation and verification of cleaning processes, William E. Hall; analytical methods validation, Ludwig Huber; computer systems validation, Tony de Claire; integrated packaging validation, Mervyn J. Frederick; analysis of process data using quality control charts, Peter Cheng and John Dutt; statistical methods for blend uniformity and dissolution testing, Bergum and Utter; change control and SUPAC, Nellie H. Waterland and Christopher C. Kowtna; process validation and quality assurance; Carl B. Rifino; validation in contract manufacturing, Dilip M. Parikh; terminology on non-aseptic process validation, Kenneth G. Chapman; harmonization, GMPs, and validation, Alfred Wachter.
