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Guidance Documents/Guidance-Document/Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry

Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

August 9, 2018

April 16, 2020

Center for Drug Evaluation and Research

b9156407-8a16-47ed-a9dc-f5ba2ff61852

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