The phase 0 microdosing concept
Version of Record online: 20 JAN 2006
British Journal of Clinical Pharmacology
Volume 61, Issue 4, pages 367–370, April 2006
How to Cite
Garner, R. C. and Lappin, G. (2006), Commentary. British Journal of Clinical Pharmacology, 61: 367–370. doi: 10.1111/j.1365-2125.2006.02575.x
- Issue online: 24 JAN 2006
- Version of Record online: 20 JAN 2006
- Received 8 September 2005 Accepted 11 October 2005
- 2Parexel’s Pharmaceutical R & D. Statistical Sourcebook . Parexel , Waltham Massachusetts, USA , 20032004 .
- 3Food and Drug Administration. Innovation or Stagnation. Challenge and Opportunity on the Critical Path to New Medical Products . Food and Drug Administration , Washington DC, USA , 2004 .
- 9Committee for Medicinal Products for Human Use . Position Paper on non-clinical safety studies to support clinical trials with a single microdose. EMEA CPMP/SWP/2599/02/Rev 1 , 2004 .
- 10Guidance For Industry . Exploratory IND Studies. Guidance . US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research , Washington DC, USA , 2006 .