Bioavailability and bioequivalence requirements
From Codex of clinical research
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Bioavailability/Bioequivalence (BA/BE) and nonclinical Good Laboratory Practice (GLP) requirements of US FDA
External links
- Bioavailability and Bioequivalence Requirements - CFR Part 320 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.38 Accessed Jun 2024
- M10 Bioanalytical Method Validation and Study Sample Analysis - Guidance document https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation-and-study-sample-analysis Accessed Jun 2024
- Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples - Draft Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/handling-and-retention-bioavailability-ba-and-bioequivalence-be-testing-samples Accessed Jun 2024
- Good Laboratory Practice for Nonclinical Laboratory Studies https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/good-laboratory-practice-nonclinical-laboratory-studies Accessed Jun 2024
- Office of Study Integrity and Surveillance - Virtual workshop Videos, 19-20 July 2022 https://www.fda.gov/drugs/news-events-human-drugs/office-study-integrity-and-surveillance-osis-workshop-2022-cder-inspections-good-laboratory-practice Accessed Jun 2024