21:5.0.1.1.8.1 | SUBPART A
| Subpart A - General Provisions | |
21:5.0.1.1.8.1.1.1 | SECTION 320.1
| 320.1 Definitions. | |
21:5.0.1.1.8.2 | SUBPART B
| Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | |
21:5.0.1.1.8.2.1.1 | 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 Basis for measuring in vivo bioavailability or demonstrating bioequivalence. | |
21:5.0.1.1.8.2.1.4 | SECTION 320.24
| 320.24 Types of evidence to measure bioavailability or establish bioequivalence. | |
21:5.0.1.1.8.2.1.5 | SECTION 320.25
| 320.25 Guidelines for the conduct of an in vivo bioavailability study. | |
21:5.0.1.1.8.2.1.6 | SECTION 320.26
| 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study. | |
21:5.0.1.1.8.2.1.7 | SECTION 320.27
| 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study. | |
21:5.0.1.1.8.2.1.8 | SECTION 320.28
| 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence. | |
21:5.0.1.1.8.2.1.9 | SECTION 320.29
| 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study. | |
21:5.0.1.1.8.2.1.10 | SECTION 320.30
| 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration. | |
21:5.0.1.1.8.2.1.11 | SECTION 320.31
| 320.31 Applicability of requirements regarding an “Investigational New Drug Application.” | |
21:5.0.1.1.8.2.1.12 | SECTION 320.32
| 320.32 Procedures for establishing or amending a bioequivalence requirement. | |
21:5.0.1.1.8.2.1.13 | SECTION 320.33
| 320.33 Criteria and evidence to assess actual or potential bioequivalence problems. | |
21:5.0.1.1.8.2.1.14 | SECTION 320.34
| 320.34 Requirements for batch testing and certification by the Food and Drug Administration. | |
21:5.0.1.1.8.2.1.15 | SECTION 320.35
| 320.35 Requirements for in vitro testing of each batch. | |
21:5.0.1.1.8.2.1.16 | SECTION 320.36
| 320.36 Requirements for maintenance of records of bioequivalence testing. | |
21:5.0.1.1.8.2.1.17 | SECTION 320.38
| 320.38 Retention of bioavailability samples. | |
21:5.0.1.1.8.2.1.18 | SECTION 320.63
| 320.63 Retention of bioequivalence samples. | |