Abstract
Pharmaceutical equivalence is an important issue in the regulatory approval of generic and similar drug products, particularly for those that will not be tested for bioequivalence. However, there is no scientific approach that provides us an objective measure of quality and similarity of the results obtained for testing (generic or similar) and branding drug products simultaneously. This paper describes a new multivariate similarity factor for the assessment of in vitro therapeutic equivalence between two medicines by using pharmaceutical equivalence study. We performed pharmaceutical equivalence studies for acyclovir cream, metronidazole injection, meropenem for injection and atropine sulfate injection. All tests and assays results were standardized using an appropriate desirability function. Multivariate similarity factors for pharmaceutical studies were calculated based on individual acceptance factors and similarity deviations for brand, generic, and similar drugs. We found a perfect correlation among multivariate similarity factor and regulatory requirements. The multivariate similarity factor is a useful tool for in vitro therapeutic equivalence assessment, and may be used for regulatory approval of generic and similar drugs. Key words: Therapeutic equivalency, in vitro, multivariate analysis.
Highlights
Drug access provision is a worldwide concern, and generic drug products play an important role in this issue
Due to the biopharmaceutical classification of active pharmaceutical ingredients, some oral drug products are exempted from bioequivalence (Brasil, 2007a;b)
We described a new multivariate similarity factor to assess in vitro therapeutic equivalence based on pharmaceutical equivalence studies
Summary
Drug access provision is a worldwide concern, and generic drug products play an important role in this issue. Generic drug products increase market competition, provide a more effective price control, promote national industrial development and allow physicians and patients to choose among different manufacturers (Dias and Romano-Lieber, 2006; Rumel et al, 2006). In Brazil, the generic drug products are part of the drug national policy, which obligates the government to provide drugs for Brazilian citizens (Rumel et al, 2006; Brasil, 1999). Similar drug products (non-generic copies of reference drug products) are important for Brazilian‟s drug national policy (Brasil, 2007b).
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