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Title 21 - Title 21

Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

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Details about Part 320

Description

DRUGS FOR HUMAN USE - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

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19 sections

§320.1 - Definitions.

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§320.21 - Requirements for submission of bioavailability and bioequivalence data.

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§320.22 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

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§320.23 - Basis for measuring in vivo bioavailability or demonstrating bioequivalence.

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§320.24 - Types of evidence to measure bioavailability or establish bioequivalence.

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§320.25 - Guidelines for the conduct of an in vivo bioavailability study.

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§320.26 - Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

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§320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

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§320.28 - Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

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§320.29 - Analytical methods for an in vivo bioavailability or bioequivalence study.

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§320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.

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§320.31 - Applicability of requirements regarding an “Investigational New Drug Application.”

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§320.32 - Procedures for establishing or amending a bioequivalence requirement.

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§320.33 - Criteria and evidence to assess actual or potential bioequivalence problems.

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§320.34 - Requirements for batch testing and certification by the Food and Drug Administration.

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§320.35 - Requirements for in vitro testing of each batch.

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§320.36 - Requirements for maintenance of records of bioequivalence testing.

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§320.38 - Retention of bioavailability samples.

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§320.63 - Retention of bioequivalence samples.

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