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EMA Issues Update on First-in-Human Trials Guideline.
- Source :
- Applied Clinical Trials; Dec2016/Jan2017, Vol. 25 Issue 12, p17-17, 1/2p
- Publication Year :
- 2016
-
Abstract
- The article offers information on European Medicines Agency updated its plan for existing guideline on first-in-human clinical trials. Topics discussed include use of integration of pharmacokinetic and pharmacodynamic data, aim of the guideline to increase first-in-human clinical trials, and need to introduce principle for starting dose in humans and dose escalation.
- Subjects :
- GUIDELINES
PHARMACOKINETICS
CLINICAL trials
DRUG dosage
Subjects
Details
- Language :
- English
- ISSN :
- 10648542
- Volume :
- 25
- Issue :
- 12
- Database :
- Complementary Index
- Journal :
- Applied Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 120468425