EMEA 微剂量给药.pdf

EU GUIDELINE - AS ADOPTED IN AUSTRALIA BY THE TGA - - WITH AMENDMENT - POSITION PAPER ON NON-CLINICAL SAFETY STUDIES TO SUPPORT CLINICAL TRIALS WITH A SINGLE MICRODOSE (CPMP/SWP/2599/02/ Rev 1) This EU guideline has been adopted in Australia by the TGA, with the following notation: IT IS STRONGLY RECOMMENDED THAT SPONSORS DISCUSS THE APPROPRIATENESS OF THEIR NON-CLINICAL SAFETY PROGRAM (SUPPORTING SINGLE MICRODOSE CLINICAL TRIALS) WITH TGA PRIOR TO SUBMISSION IN ORDER TO CLARIFY DATA EXPECTATIONS Effective: May 2005 Published: TGA website Address: PO Box 100 Woden ACT 2606 Website: .au Telephone: 02 6232 8444 Facsimile: 02 6232 8605 ABN 40 939 406 804 European Medicines Agency Evaluation of Medicines for Human Use London, 23 June 2004 CPMP/SWP/2599/02/Rev 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) POSITION PAPER ON NON-CLINICAL SAFETY STUDIES TO SUPPORT CLINICAL TRIALS WITH A SINGLE MICRODOSE DISCUSSION IN THE SAFETY WORKING PARTY June 2002 TRANSMISSION TO CPMP June 2002 RELEASE FOR CONSULTATION June 2002 DEADLINE FOR COMMENTS September 2002 DISCUSSION OF COMMENTS BY THE SAFETY WORKING October 2002 PARTY ADOPTION BY CPMP January 2003 DATE O