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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
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 A--GENERAL PROVISIONS
Subpart B--PROCEDURES FOR DETERMINING THE BIOAVAILABILITY OR BIOEQUIVALENCE OF DRUG PRODUCTS
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| Requirements for submission of bioavailability and bioequivalence data. |
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| Criteria for waiver of evidence of in vivo bioavailability or bioequivalence. |
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| Basis for measuring in vivo bioavailability or demonstrating bioequivalence. |
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| Types of evidence to measure bioavailability or establish bioequivalence. |
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| Guidelines for the conduct of an in vivo bioavailability study. |
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| Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study. |
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| Guidelines on the design of a multiple-dose in vivo bioavailability study. |
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| Correlation of bioavailability with an acute pharmacological effect or clinical evidence. |
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| Analytical methods for an in vivo bioavailability or bioequivalence study. |
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| Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration. |
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| Applicability of requirements regarding an ''Investigational New Drug Application.'' |
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| Procedures for establishing or amending a bioequivalence requirement. |
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| Criteria and evidence to assess actual or potential bioequivalence problems. |
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| Requirements for batch testing and certification by the Food and Drug Administration. |
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| Requirements for in vitro testing of each batch. |
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| Requirements for maintenance of records of bioequivalence testing. |
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| Retention of bioavailability samples. |
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| Retention of bioequivalence samples. |
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