FDA Guidance for Industry: SUPAC-IR Immediate Release Solid Oral Dosage Forms, Scale - Up and Post-approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, In Vivo Bioequivalence Documentation, Guidance November 1995

Titel:
FDA Guidance for Industry: SUPAC-IR Immediate Release Solid Oral Dosage Forms, Scale - Up and Post-approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, In Vivo Bioequivalence Documentation, Guidance November 1995
Herkunft/Verlag:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070636.pdf

Dokumentenart:
ICH Guidlines
Inhalt:
Diese FDA-Guideline bezieht sich auf Änderungen nach der Zulassung bei schnell freisetzenden, festen Darreichungsformen.

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