List of Code of Federal Regulations (CFR) related to BA/BE studies [With links]

About Code of Federal Regulations (CFR):

 

CFR is the codification of the general and permanent rules and regulations published in the federal register by excutive department and agencies of the federal government of USA.

 

CFR has total 50 titles:

 

Title 21 of CFR represents Foods and Drugs

Title 21 is again divided in to three Chapters:

 

Chapter I: Food and Drug Administration

Chapter II: Drug enforcement Administration

Chapter III: Office of National Drug Control policy

 

Below is the List of sections in the Code of Federal Regulations (CFR) related to bio-availability and bio-equivalence (BA/BE) studies

 

21CFR 320    BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

 

21CFR 320.1  

Definitions

 

This section covers Definitions of bioavailability, pharmaceutical equivalents, pharmaceutical alternatives, and bioequivalence

 

21CFR 320.21    

Requirements for submission of bioavailability and bioequivalence data

 

 

21CFR 320.22  

Criteria for waiver of evidence of in vivo bioavailability or bioequivalence

 

 

21CFR 320.23

Basis for measuring in vivo bioavailability or demonstrating bioequivalence

 

 

21CFR 320.24

Types of evidence to measure bioavailability or establish bioequivalence

 

 

21CFR 320.25

Guidelines for the conduct of an in vivo bioavailability study

 

 

21CFR 320.26

Guidelines on the design of a single dose in vivo bioavailability or bioequivalence study

 

 

21CFR 320.27

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

 

 

21CFR 320.28

Correlation of bioavailability with an acute pharmacological effect or clinical evidence

 

 

21CFR 320.29

Analytical methods for an in vivo bioavailability or bioequivalence study

 

 

21CFR 320.30

Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the FDA

 

21CFR 320.32

Procedures for establishing or amending a bioequivalence requirement

 

21CFR 320.33

Criteria and evidence to assess actual or potential bioequivalence problems

 

21CFR 320.36

Requirements for maintenance of records of bioequivalence testing

 

21CFR 320.38

Retention of bioavailability samples

 

21CFR 320.63

Retention of bioequivalence samples

 

 Also See:

 

21CFR PART 50                 

Protection of Human Subjects

This part 50 covers about informed consent process and requirements for human subjects also covers the additional safeguards for children in clinical investigation and IRB duties etc.

 

21 CFR Part 56 

Institutional Review Boards

 

21 CFR Part 11            

Electronic Records; Electronic Signatures

 

21CFR 314.94(a)(9)

Chemistry, manufacturing, and controls; covers the following:

 

(ii) Inactive ingredients characterization and identification

 

(iii) Inactive ingredient changes permitted in drug products intended for parenteral use

 

(iv) Inactive ingredient changes permitted in drug products intended for ophthalmic or otic use

 

(v) Inactive ingredient changes permitted in drug products intended for topical use

 

 

 

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