Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / / by John J. Tobin and Gary Walsh

• Autore: Tobin Jack (John J.)
• Pubblicazione: Weinheim, [Germany] : , : Wiley-Blackwell, , 2008; ©2008
• Descrizione fisica: 1 online resource (299 p.)
• Disciplina: 344.041; 344.0416
• Soggetto topico: Drugs - Law and legislation; Pharmacy - Law and legislation; Medical instruments and apparatus - Law and legislation
• Persona (resp. second.): WalshGary
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references at the end of each chapters and index.
• Nota di contenuto: Medical Product Regulatory Affairs; Contents; Preface; 1 The Aims and Structure of Regulations; 2 Regulatory Strategy; 3 Drug Discovery and Development; 4 Non-Clinical Studies; 5 Clinical Trials; 6 Marketing Authorisation; 7 Authorisation of Veterinary Medicines; 8 Variations to the Drug Authorisation Process; 9 Medical Devices; 10 Authorisation of Medical Devices; 11 Good Manufacturing Practice (GMP); 12 Oversight and Vigilance; Index
• Sommario/riassunto: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.Everything pharmacolog
• Titolo autorizzato: Medical product regulatory affairs
• ISBN: 3-527-64471-7; 1-281-94710-5; 9786611947101; 3-527-62303-5; 3-527-62304-3
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910830635603321
• Lo trovi qui: Univ. Federico II