The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials

Author:

Marchetti S,Schellens J H M

Publisher

Springer Science and Business Media LLC

Subject

Cancer Research,Oncology

Reference25 articles.

1. Center for Drug Evaluation and Research (CDER) (2006) Guidance for Industry, Investigators, and Reviewers – Exploratory IND Studies. Center for Drug Evaluation and Research (CDER), Food and Drug Administration, US Department of Health and Human Services, January 2006 ( http://www.fda.gov/cder/guidance/7086fnl.htm )

2. CHMP/SWP/91850/2006. Concept Paper on the development of a CHMP guideline on the non-clinical requirements to support early Phase I clinical trials with pharmaceutical compounds. European Medicines Agency (EMEA), committee for medicinal products for human use (CHMP), March 2006 ( http://www.emea.europa.eu/pdfs/human/swp/9185006en.pdf )

3. CPMP/EWP/205/95/Rev.3/Corr.2. Guideline on the evaluation of anticancer medicinal products in man. European Medicines Agency (EMEA), committee for medicinal products for human use (CHMP), December 2005 ( http://www.emea.eu.int/pdfs/human/ewp/020595en.pdf )

4. CPMP/SWP/2599/02/Rev1. Position Paper on non-clinical safety studies to support clinical trials with a single microdose. European Medicines Agency (EMEA), committee for medicinal products for human use (CHMP), June 2004 ( http://www.emea.europa.eu/pdfs/human/swp/259902en.pdf )

5. DiMasi JA (2001) Risk in new drug development: approval success rate for investigational drugs. Clin Pharmacol Ther 69: 297–307

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