Code of Federal Regulations · Subpart
Subpart B — Procedures For Determining The Bioavailability Or Bioequivalence Of Drug Products
21 C.F.R. pt. 320, subpt. B
- § 320.21 Requirements For Submission Of Bioavailability And Bioequivalence Data
- § 320.22 Criteria For Waiver Of Evidence Of In Vivo Bioavailability Or Bioequivalence
- § 320.23 Basis For Measuring In Vivo Bioavailability Or Demonstrating Bioequivalence
- § 320.24 Types Of Evidence To Measure Bioavailability Or Establish Bioequivalence
- § 320.25 Guidelines For The Conduct Of An In Vivo Bioavailability Study
- § 320.26 Guidelines On The Design Of A Single-dose In Vivo Bioavailability Or Bioequivalence Study
- § 320.27 Guidelines On The Design Of A Multiple-dose In Vivo Bioavailability Study
- § 320.28 Correlation Of Bioavailability With An Acute Pharmacological Effect Or Clinical Evidence
- § 320.29 Analytical Methods For An In Vivo Bioavailability Or Bioequivalence Study
- § 320.30 Inquiries Regarding Bioavailability And Bioequivalence Requirements And Review Of Protocols By The Food And Drug Administration
- § 320.31 Applicability Of Requirements Regarding An “investigational New Drug Application.”
- § 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 By The Food And Drug Administration
- § 320.35 Requirements For In Vitro Testing Of Each Batch
- § 320.36 Requirements For Maintenance Of Records Of Bioequivalence Testing
- § 320.38 Retention Of Bioavailability Samples
- § 320.63 Retention Of Bioequivalence Samples