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Therapeutic Equivalency of Low-Molecular-Weight Heparins
OBJECTIVE: To review the recent literature on the approved uses of enoxaparin, dalteparin, ardeparin, and tinzaparin and the evidence for therapeutic equivalence. DATA SOURCES: A MEDLINE search (1993–January 2001) was conducted to identify English-language literature available on enoxaparin, dalteparin, ardeparin, and tinzaparin.
Gary M, McCart, Steven R, Kayser
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Understanding Therapeutic Equivalence in Epilepsy
CNS Spectrums, 2010ABSTRACTThe issues surrounding generic drug substitution in patients with epilepsy are complex.The substitution of one formulation of an antiepileptic drug (AED) for another is controversial. Well-reasoned and defensible cases can be made both for and against such substitution.
Raman, Sankar, Tracy A, Glauser
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The therapeutic equivalence of complex drugs
Regulatory Toxicology and Pharmacology, 2011When the patent of a small molecule drug expires generics may be introduced. They are considered therapeutically equivalent once pharmaceutical equivalence (i.e. identical active substances) and bioequivalence (i.e. comparable pharmacokinetics) have been established in a cross-over volunteer study.
Schellekens, Huub +5 more
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Therapeutic equivalency of two lidocaine preparations
American Journal of Health-System Pharmacy, 1976Twenty-five volunteers were studied as to the onset and duration of action of two commercial brands of lidocaine. One and two percent concentrations of the preparations were tested intradermally using a double-blind, cross-over protocol. Both needle-drop and electrical stimulation techniques were employed as the source of pain stimulus. Five additional
J E, Stambaugh +2 more
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GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE
JAMA: The Journal of the American Medical Association, 1968In recent years, there has developed the belief that nonproprietary or generic drugs are much cheaper than, and as effective as, trade-named items. This belief has led to a widespread demand that prescribing and use of generic drugs be encouraged. Studies conducted by impartial groups such as the Medical Letter on Drugs and Therapeutics have applied ...
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Therapeutic equivalence: fallacies and falsification
Statistics in Medicine, 2003AbstractThe number of studies designed specifically to demonstrate therapeutic equivalence or alternatively non‐inferiority of pharmaceutical treatments has increased dramatically in recent years, during which time awareness of the methodological issues has increased. Regulatory authorities have been quick to recognize the need for specific support and
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Therapeutic equivalence investigations: statistical considerations
Statistics in Medicine, 1998Therapeutic equivalence studies still present problems to regulatory reviewers from many perspectives. This paper is intended to discuss some of these concerns from the statistical viewpoint. There are, however, also some newer approaches which may be particularly useful for the investigation of therapeutic equivalence.
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Therapeutic equivalency of procainamide—A correction
Blair P. Grubb
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