Clinical trials audit preparation: a guide for good clinical practice (GCP) inspections
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Bibliographische Detailangaben
1. Verfasser: Mihajlovic-Madzarevic, Vera (VerfasserIn)
Format: Elektronisch E-Book
Sprache:English
Veröffentlicht: Hoboken, N.J. Wiley c2010
Schlagworte:
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Beschreibung:Includes bibliographical references and index
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
Beschreibung:1 Online-Ressource (xxi, 246 p.)
ISBN:9780470572757
0470572752
9780470572740
0470572744
9780470920886
0470920882

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