1. The History of Microdose Clinical Trials

Author:

MAYAHARA Hiroshi1

Affiliation:

1. International Clinical Research Organization for Medicine

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical),Pharmacology

Reference12 articles.

1. 1) EU/EMEA/CPMP: Position Paper on non-clinical safety studies to support clinical trials with a single microdose. The European Medicines Agency (EMEA), Evaluation of Medicines for Human Use, CPMP/SWP/2599/02 London, January 23(2003), and CPMP/SWP/2599/02/Rev 1, London, June 23, (2004)

2. 2) US FDA: Guidance for Industry, Investigators and Reviewers, Exploratory IND Studies, US Department of Health and human Services, FDA, CDER; Jan. 12, (2006)

3. 5) US FDA: Screening INDs. Manual of Policies and Procedures (MAPP) 6030.4, Office of Review Management and Pharmaceutical Sciences. Center for Drug Evaluation and Research, FDA, 05/09/2001 (2001)

4. 6) ICH Harmonized Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, M3, (R2). (2009)

5. 7) US FDA: Guideline for the study and evaluation for gender differences in the clinical evaluation of drugs. Fed Regist. 1993; 39406-16. Food and Drug Administration, Center for Drug Evaluation and Research, Washington D. C. (1993)

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