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A multiple-dose safety and bioequivalence study of a narrow therapeutic index drug: A case for carbamazepine by YACOBI, A; ZLOTNICK, S; COLAIZZI, J; MOROS, D; MASSON, E; ABOLFATHI, Z; LEBEL, M; MEHTA, R; GOLANDER, Y; LEVITT, B is a Medicine article available to read on EtoBox.

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The term narrow therapeutic ratio is defined in the US Code of Federal Regulations at 21 CFR 320.33(c) as follows 1 : (1) there is less than a 2-fold difference in median lethal dose (LD 50 ) and median effective dose (ED 50 ) values, or (2) there is less than a 2-fold differ-ence in the minimum toxic concentrations and minimum effective concentrations in the blood, and (3) safe and effective use of the drug products requires careful titration and patient monitoring. However, no list of these drugs is included in this regulation, and the US Food and Drug Administration (FDA) has not yet shown any indication of requiring separate bioequivalence requirements for the so-called narrow therapeutic index drugs. 1 \* In a review article, "Bioequivalence and Narrow Therapeutic Index Drugs," Benet and Goyan 2 contend that these drugs are actually the least likely to pose problems in ensuring therapeutic equivalence. A multiple-dose safety and bioequivalence study of a narrow therapeutic index drug: A case for carbamazepine Background and objectives: Carbamazepine is among those drugs that have been considered to have a narrow therapeutic plasma concentration range, that is, a narrow therape

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Author

YACOBI, A; ZLOTNICK, S; COLAIZZI, J; MOROS, D; MASSON, E; ABOLFATHI, Z; LEBEL, M; MEHTA, R; GOLANDER, Y; LEVITT, B

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

1999

Language

EN

Field

Medicine (Health Sciences)