美国FDA 指导原则 CVM GFI 148(VICH GL32)在人类食品发育毒性试验中评估兽药残留安全性的研究 英文原版.pdfVIP

148 Guidance for Industry Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing VICH GL32 FINAL GUIDANCE (This version of the guidance replaces the version that was made available in March 19, 2004. This guidance document has been revised to correct the contact information in regard to this document.) This final guidance consolidates developmental toxicity testing recommendations of the EU, Japan, and the USA for establishing the safety of veterinary drug residues in human food. Comments and suggestions regarding the document should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to /. All comments should be identified with the Docket No. 2002D-0369. For questions regarding this document, contact the Division of Human Food Safety, Center for Veterinary Medicine, (HFV-150), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8208. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine July 27, 2006 Contains Non-Binding Recommendations VICH GL32 (SAFETY : DEVELOPMENTAL TOXICITY) October 2002 For implementation at Step 7 - Final STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN