2 options
Post-approval safety data management : definitions and standards for expedited reporting.
- Format:
- Book
- Conference/Event
- Government document
- Conference Name:
- International Conference on Harmonisation http://viaf.org/viaf/130234339
- Language:
- English
- Subjects (All):
- Drugs--Side effects--Reporting.
- Drugs.
- Clinical pharmacology.
- Pharmacovigilance.
- Drug monitoring.
- Physical Description:
- 1 online resource (12)
- Other Title:
- Definitions and standards for expedited reporting
- Place of Publication:
- [Rockville, Md.?] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [2003]
- Notes:
- Title from PDF title page (viewed on June 19, 2009).
- "ICH harmonised tripartite guideline draft."
- "Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee."
- "ICH E2E ver. 3.8."
- OCLC:
- 404100715
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