美国FDA 指导原则 CVM GFI 147(VICH GL31)在人类食品重复剂量(90天)毒性试验中评价兽药残留安全性的研究 英文原版.pdfVIP

147 Guidance for Industry Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing VICH GL31 Final Guidance (This version of the guidance replaces the version that was made available in November 12, 2003. This guidance document has been revised to correct the contact information in regard to this document.) The objective of this guidance is to establish recommendations for an internationally harmonized 90-day repeat-dose testing 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. 02D- 0368. 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 GL31 (SAFETY : REPEAT-DOSE (90-DAY) TOXICITY) October 2002 For implementation at Step 7 - Final