美国FDA 指导原则 CVM GFI 160(VICH GL37)在人类食品重复剂量(慢性)毒性试验中评价兽药残留安全性的研究 英文原版.pdfVIP

Contains Non-Binding Recommendations 160 Guidance for Industry Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing VICH GL-37 FINAL GUIDANCE (This version of the guidance replaces the version that was made available in February 4, 2005. This guidance document has been revised to correct the contact information in regard to this document.) 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. 2003D-0466. 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. Additional copies of this guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at /AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm . U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine July 27, 2006 VICH GL37 (SAFETY) May 2004