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Good Clinical Practice - Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance (Paperback)
Mindy J. Allport-SettleSelected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents
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Product Description
Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents
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Product Details
General
Imprint | Pharmalogika |
Country of origin | United States |
Release date | October 2010 |
Availability | Expected to ship within 10 - 15 working days |
First published | October 2010 |
Authors | Mindy J. Allport-Settle |
Dimensions | 235 x 191 x 38mm (L x W x T) |
Format | Paperback - Trade |
Pages | 752 |
ISBN-13 | 978-0-9821476-8-9 |
Barcode | 9780982147689 |
Categories | |
LSN | 0-9821476-8-6 |
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