# SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/supac-ss-nonsterile-semisolid-dosage-forms-scale-up-and-post-approval-changes-chemistry-manufacturing-and-controls-in-vitro-release-testing-and-in-vivo-bioequivalence-documentation-guidance-for-industry/d127b90c-a5cb-4a59-8be5-7d05eabe3377

> FDA guidance document: SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation:  Guidance for Industry. Issue date: May 01, 1997. Get complete insights and analysis.

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## Details

- Title: SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation:  Guidance for Industry
- 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: 1997-05-01
- Last Changed: 2020-05-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1997-D-0380">FDA-1997-D-0380</a>

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