Research Catalog
Safety pharmacology in pharmaceutical development and approval / Shayne C. Gad.
- Title
- Safety pharmacology in pharmaceutical development and approval / Shayne C. Gad.
- Author
- Gad, Shayne C., 1948-
Items in the Library & Off-site
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1 Item
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Use in library | RA1238 .G333 2004 | Off-site |
Details
- Additional Authors
- Gad, Shayne C.,
- Description
- 189 p. : ill.; 24 cm.
- Summary
- "Safety Pharmacology in Pharmaceutical Development and Approval spells out the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery." "Until recently, pharmacovigilance has been product - rather than utilization - oriented and often invisible in clinical medicine. It is clear that definitive safety pharmacology standards are needed to combat the increase in adverse reactions seen in the last 20 years. Safety Pharmacology in Pharmaceutical Development and Approval addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into the existing safety evaluations."--BOOK JACKET.
- Subjects
- ISBN
- 0849313805 (alk. paper)
- LCCN
- 2003051468
- Owning Institutions
- Columbia University Libraries