Compatibility of pharmaceutical products and contact materials : safety considerations associated with extractables and leachables / / Dennis Jenke

• Record Nr.: UNINA9910143081303321
• Autore: Jenke Dennis
• Pubbl/distr/stampa: Hoboken, New Jersey : , : Wiley, , 2009; ©2009
• ISBN: 1-118-67947-4; 1-282-18827-5; 9786612188275; 0-470-45941-7; 0-470-45940-9
• Descrizione fisica: 1 online resource (401 p.)
• Disciplina: 615.19; 615/.190289
• Soggetti: Drugs - Containers - Safety measures; Drug delivery devices - Safety measures
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: Nomenclature and central concepts -- Extractables, leachables, and the product life cycle -- Material screening and characterization -- The prototype stage -- The early development stage -- Late stage product development -- Submission -- Launch -- Product maintenance -- Retirement -- Focus on emerging concepts.
• Sommario/riassunto: Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regul