United States Government Publishing Office publisher pbl distributor dst United States Health and Human Services Department Food and Drug Administration author aut Government Organization text government publication eng GOVPUB Executive Agency Publications executive 2023-06-06 Health and Human Services Department 2005-01-01 monographic harvested born digital 17 digital object pages HE 20.4702:B 52/2 https://www.govinfo.gov/app/details/GOVPUB-HE20_4000-PURL-LPS113768 P0b002ee1bea8e1d2 000878778 https://purl.fdlp.gov/GPO/LPS113768 (OCoLC)400009435 DGPO 2023-06-06 2025-07-01 GOVPUB-HE20_4000-PURL-LPS113768 machine generated eng fdlp HE20_4000 GOVPUB-HE20_4000-PURL-LPS113768 PURL-LPS113768 GOVPUB This content was harvested from online sources of the original hosting or authoring agency and may not reflect current policy. As Federal agencies add publications to their websites, or report new publications to GPO per statutory mandate (44 U.S.C. §§ 1710, 1902-1903), GPO ensures long-term preservation of and access to the content. 2005 PERM_INGEST_04282022 LPS113768 https://www.govinfo.gov/app/details/GOVPUB-HE20_4000-PURL-LPS113768 https://www.govinfo.gov/content/pkg/GOVPUB-HE20_4000-PURL-LPS113768/pdf/GOVPUB-HE20_4000-PURL-LPS113768.pdf Q5e Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process Biological products Biotechnological process monitoring Pharmaceutical biotechnology International Conference on Harmonisation. 0499-T (online) Center for Drug Evaluation and Research (U.S.) Center for Biologics Evaluation and Research (U.S.) mdu U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research Center for Biologics Evaluation and Research [2005] monographic

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1 online resource (14 pages) HE 20.4702:B 52/2 0499-T (online) text bibliography eng Title from title screen (viewed on June 16, 2009). "ICH". "June 2005". Includes bibliographical references (page 14). Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf ; current access is available via PURL. Biotechnological process monitoring Pharmaceutical biotechnology Biological products International Conference on Harmonisation. https://purl.fdlp.gov/GPO/LPS113768 https://catalog.gpo.gov/fdlpdir/locate.jsp?ItemNumber=0499-T&SYS=000878778 Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process