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Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections /
A must-have guide for any professional in the drug manufacturing industry. The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
Wiley,
©2010.
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| Temas: | |
| Acceso en línea: | Texto completo |
| Sumario: | A must-have guide for any professional in the drug manufacturing industry. The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and instit. |
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| Descripción Física: | 1 online resource (xxi, 246 pages) : illustrations |
| Bibliografía: | Includes bibliographical references and index. |
| ISBN: | 9780470572757 0470572752 9780470572740 0470572744 9780470920886 0470920882 1283024845 9781283024846 9786613024848 6613024848 |