| Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 2, Guidance Contributor(s): Allport-Settle, Mindy J. (Author) |
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ISBN: 0982147686 ISBN-13: 9780982147689 Publisher: Pharmalogika OUR PRICE: $46.54 Product Type: Paperback - Other Formats Published: October 2010 |
| Additional Information |
| BISAC Categories: - Medical | Research |
| Physical Information: 1.5" H x 7.52" W x 9.25" (2.80 lbs) 752 pages |
| Descriptions, Reviews, Etc. |
| Publisher 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 |