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[Me too's and generics].

E Gysling

    Praxis
    |June 4, 1999
    PubMed
    Summary

    Generic drugs offer cost savings but must be bioequivalent to original medications. Not all generics are interchangeable, and branded generics are recommended for patient safety.

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    Area of Science:

    • Pharmacoeconomics
    • Pharmaceutical Sciences
    • Clinical Pharmacology

    Context:

    • Generic medications are widely used to reduce healthcare costs.
    • Regulatory standards require generics to demonstrate bioequivalence to reference listed drugs.
    • Inter-individual variability exists between different generic formulations of the same active substance.

    Purpose:

    • To evaluate the clinical implications of generic drug substitution.
    • To assess the bioequivalence criteria for generic medications.
    • To provide guidance on the appropriate use of generics in pharmacotherapy.

    Summary:

    • Generics contain the same active substance as branded drugs and aim to lower pharmacotherapy costs.
    • Bioequivalence is established if the mean area under the curve (AUC) does not deviate by more than 20% from the original drug.
    • Crucially, one generic may not be bioequivalent to another generic of the same drug.

    Impact:

    • Prescribing branded generics is advised from a medical standpoint.
    • Close collaboration among healthcare providers can minimize conflicts related to generic use.
    • Avoid generic drugs when a superior non-generic alternative exists.

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