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FDA Guidance for Industry: Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs

Origin/Publisher:

FDA

Content:
This guidance is developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/or abbreviated new drug applications (ANDAs), as appropriate, for immediate-release (IR) tablets and capsules that contain highly soluble drug substances.

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