01611oam 2200433 a 450 991070218700332120120912150042.0(CKB)5470000002424265(OCoLC)400009435(EXLCZ)99547000000242426520090615d2005 ua 0engurbn|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] Q5E comparability of biotechnological/biological products subject to changes in their manufacturing processRockville, MD :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]1 online resource (14 pages)Title from title screen (viewed on June 16, 2009)."ICH"."June 2005".Includes bibliographical references (page 14).Guidance for industry Biotechnological process monitoringPharmaceutical biotechnologyBiological productsBiotechnological process monitoring.Pharmaceutical biotechnology.Biological products.Center for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOGPOBOOK9910702187003321Guidance for industry3434577UNINA