用于检测治疗性蛋白制品的免疫原性的检测法开发和验证英文版.pdf

Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions regarding this draft document, contact (CDER) Susan Kirshner at 301-827-1731; (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010; or (CDRH) Office of Communication and Education, 800-638-2041 or 301-796-7100. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) April 2016 Pharmaceutical Quality/CMC Revision 1 I :\\16645dftR1.doc 4/20/16 Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Dr