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Record Nr. |
UNINA9910144253403321 |
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Autore |
Tobin Jack (John J.) |
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Titolo |
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / / by John J. Tobin and Gary Walsh |
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Pubbl/distr/stampa |
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Weinheim, [Germany] : , : Wiley-Blackwell, , 2008 |
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©2008 |
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ISBN |
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3-527-64471-7 |
1-281-94710-5 |
9786611947101 |
3-527-62303-5 |
3-527-62304-3 |
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Descrizione fisica |
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1 online resource (299 p.) |
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Disciplina |
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Soggetti |
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Drugs - Law and legislation |
Pharmacy - Law and legislation |
Medical instruments and apparatus - Law and legislation |
Electronic books. |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references at the end of each chapters and index. |
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Nota di contenuto |
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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 |
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Sommario/riassunto |
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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 |
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