Information om | Engelska ordet BIOEQUIVALENCE

Exempel på hur man kan använda BIOEQUIVALENCE i en mening

• In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study to volunteer subjects, generally healthy individuals but occasionally in patients.
• Gilberto De Nucci founded the Cartesius Analytical Unit, a very important enterprise on the quality approval of new drugs as "generics" throughout bioequivalence essays.
• In cases of topically active drugs, the bioequivalence of a drug can be demonstrated by comparing drugs dissolution or transdermal drug absorption is compared with the innovator drug.
• Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure–response (pharmacokinetics/pharmacodynamics studies).
• For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug.

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