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Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance

Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance

Paperback

Medical Reference

ISBN10: 0982147686
ISBN13: 9780982147689
Publisher: Createspace
Published: Oct 3 2010
Pages: 752
Weight: 2.80
Height: 1.50 Width: 7.52 Depth: 9.25
Language: English
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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Medical Reference