BPS 2110 Lecture Notes - Lecture 6: Teva Pharmaceutical Industries, Gabapentin, Ibuprofen
7 Nov 2017
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The use of generic medicines: a focus on mental. Total prescriptions in canada 2009: 46% brand, 54% generic. Approval process for generic drugs (us fda standards) Contain the same active ingredients as the reference drug, although inactive ingredients may vary. Be identical to the reference drug in strength, dosage form, and route of administration. Meet the same batch requirements for identity, strength, purity, and quality. Be manufactured under the same strict fda standards of current manufacturing. Bioequivalence: in most countries (us and europe) two products are bioequivalent if. The 90% con dence interval (ci) of the relative mean auc of the test to reference product should be within the 80 - 125% range. The 90% ci of the relative mean of cmax of the test to reference product should be within the 80 - Manufactures of innovator drug must not show a greater than 5% variation. The 80 - 125% tmax should be present as well but is not required.
