FDA Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
Titel:
FDA Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
Internet:
Herkunft/Verlag:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073476.pdf
Dokumentenart:
FDA Guidance for Industry
Inhalt:
Diese Guideline bietet eine Anleitung zur Einschätzung der Vergleichbarkeit biotechnologisch gefertigter Produkte vor und nach Änderungen im Herstellungsprozess.