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§ 320.32: Procedures for establishing or amending a bioequivalence requirement. § 320.33: Criteria and evidence to assess actual or potential bioequivalence problems. § 320.34: Requirements for batch testing and certification…

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§ 320.32 - Procedures for establishing or amending a bioequivalence requirement. § 320.33 - Criteria and evidence to assess actual or potential bioequivalence problems. § 320.34 - Requirements for...

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part 320 -- bioavailability and bioequivalence requirements Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products Sec. 320. 21 Requirements for submission of bioavailability and bioequivalence data.

9. MÄRZ 2022

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21 cfr part 314 - applications for fda approval to market a new drug; 21 cfr part 315 - diagnostic radiopharmaceuticals; 21 cfr part 320 - bioavailability and bioequivalence requirements

14. JAN. 2021

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Applications for FDA Approval to Market a New Drug ( 21 CFR Part 314) Bioavailability and Bioequivalence Requirements ( 21 CFR Part 320) New Animal Drugs for Investigational Use ( 21 CFR Part…

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PART 320 -- BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS. Subpart A - General Provisions

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Title 21 —Food and Drugs; Chapter I —Food and Drug Administration, Department of Health and Human Services; Subchapter D —Drugs for Human Use; Part 320 —Bioavailability and Bioequivalence Requirements; Subpart…

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SECTION 320.21 320.21 Requirements for submission of bioavailability and bioequivalence data. 21:5.0.1.1.8.2.1.2: SECTION 320.22 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence. 21:5.0.1.1.8.2.1.3: SECTION 320.23 320.23…

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21 • Addresses the requirement at 21 CFR 320 .38(c) to retain reserve samples of sufficient 22 quantity to permit FDA to perform five times all the release tests required in…

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Title 21 —Food and Drugs; Chapter I —Food and Drug Administration, Department of Health and Human Services; Subchapter D —Drugs for Human Use; Part 320 —Bioavailability and Bioequivalence Requirements; Subpart…

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CFR - Code of Federal Regulations Title 21. The information on this page is current as of Mar 28, 2023. For the most up-to-date version of CFR Title 21, go…

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Title 21 —Food and Drugs; Chapter I —Food and Drug Administration, Department of Health and Human Services; Subchapter D —Drugs for Human Use; Part 320 —Bioavailability and Bioequivalence Requirements; Subpart…

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Title 21 —Food and Drugs; Chapter I —Food and Drug Administration, Department of Health and Human Services; Subchapter D —Drugs for Human Use; Part 320 —Bioavailability and Bioequivalence Requirements; Subpart…