# SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/supac-ir-immediate-release-solid-oral-dosage-forms-scale-up-and-post-approval-changes-chemistry-manufacturing-and-controls-in-vitro-dissolution-testing-and-in-vivo-bioequivalence-documentation/d92f2615-a9dd-43a1-bed0-97946ea41dbf

> FDA guidance document: SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Issue date: November 01, 1995. Get complete insights and analysis.

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## Details

- Title: SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 1995-11-01
- Last Changed: 2020-05-05

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