Dissolution Technologies · 2012 · 13 citations · 9 references
PharmacyPharmaceuticsPharmacologyBioavailabilityBioequivalenceDissolution TestingBioequivalence AssessmentBioequivalence Study DesignDissolution Profile ComparisonDissolution Testing For BioequivalenceGeneric Drug EvaluationDrug Product ComparisonFormulation Equivalence AssessmentGeneric Drug Equivalence AssessmentGeneric Product EquivalenceGenerics Equivalence TestingIn Vivo StudiesReference FormulationsTherapeutic Equivalence Evaluation
This study used biowaiver conditions to assess bioequivalence of some generic products used in Nigeria. None of the generic samples tested met biowaiver conditions; therefore, in vivo bioequivalence studies are required to ascertain therapeutic equivalence. To take advantage of the cost savings of using in vitro dissolution as a surrogate for bioequivalence studies, manufacturers of generic products need to consider factors that affect solubility and permeability of their products when formulating them.
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