WebFDA issues guidance regarding bioavailability, bioequivalence sample retention; ... bioequivalence sample retention. ... The guidance was intended to address the agency’s requirements under 21 CFR 320.38(c) to retain reserve samples of enough quantity to allow the FDA to perform at least five times the release tests in an application or ... Web320.38 Retention of bioavailability samples. 320.63 Retention of bioequivalence samples. AUTHORITY: 21 U.S.C. 321, 351, 352, 355, 371. Subpart A—General Provisions §320.1 Definitions. (a) Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at
CFR - Code of Federal Regulations Title 21 - Food and …
Web(a) The applicant of an application or supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioavailability testing was performed under contract, the contract research organization shall retain an appropriately … WebParenteral Drug Association - FDA releases guidance on bioavailability and bioequivalence study samples My News Top News Potency Assay Considerations for Monoclonal Antibodies and FDA.gov News about … market is down synonym
21 CFR § 320.38 Retention of bioavailability samples - eCFR
WebThe applicant or contract research organization shall retain the reserve samples in accordance with, and for the period specified in, § 320.38 and shall release the reserve samples to FDA upon request in accordance with § 320.38 . [ 58 FR 25928, Apr. 28, 1993, as amended at 64 FR 402, Jan. 5, 1999] WebJan 17, 2024 · The retention time is as follows: (1) For an active ingredient in a drug product other than those described in paragraphs (a) (2) and (3) of this section, the reserve sample shall be retained... WebApr 12, 2024 · Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38 (c) Guidance for Industry August 2024 … market is changing