Transcription of Guidance for Industry - Trends
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Guidance for Industry - Trends
Guidance for IndustryImmediate Release Solid OralDosage FormsScale-Up and PostapprovalChanges: Chemistry,Manufacturing, and Controls, InVitro Dissolution Testing, andIn Vivo BioequivalenceDocumentationCenter for Drug Evaluation and Research (CDER)November 1995 CMC 5 TABLE OF OF OF AND COMPOSITION .. IN BATCH SIZE (SCALE-UP/SCALE-DOWN).. VITRO VIVO BIOEQUIVALENCE A: NARROW THERAPEUTIC RANGE DRUGS .. A-1 This Guidance has been prepared by the Immediate Release Scale-up and Post1 Approval Change (SUPAC) Expert Working Group of the Chemistry ManufacturingControls Coordinating Committee (CMC CC) of the Center for Drug Evaluation andResearch at the Food and Drug Administration. This Guidance is an informalcommunication under 21 CFR (b)(9) that reflects the best judgment of CDER employees at this time.
Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence
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