Antibiotic batch certification and bioequivalence.

K A DeSante; A R DiSanto; D J Chodos; R G Stoll

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PubMed · 1173399

Antibiotic batch certification and bioequivalence.

K A DeSante·A R DiSanto·D J Chodos·R G Stoll

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Abstract

All antibiotics marketed in the United States must undergo batch certification by the Food and Drug Administration. It is often assumed that the different brands of a particular antibiotic that pass in vitro batch certification tests have equal in vivo bioavailability. The fallacy of this assumption is clearly supported for commercially available lots of tetracycline hydrochloride that had passed batch certification tests yet had different serial serum concentrations.

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Administration, Oral Adult Anti-Bacterial Agents Biological Availability Biopharmaceutics Drug Stability Female Humans Legislation, Drug Male Tetracycline Therapeutic Equivalency United States United States Food and Drug Administration Journal Article

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K A DeSante, A R DiSanto, D J Chodos, R G Stoll. 1975-06-30. Antibiotic batch certification and bioequivalence.. https://pubmed.ncbi.nlm.nih.gov/1173399/

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