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Therapeutic equivalence investigations: statistical considerations

Statistics in Medicine, 1998
Therapeutic 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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Methodological standards for assessing therapeutic equivalence

Journal of Clinical Epidemiology, 1991
This paper reviews issues related to defining and demonstrating therapeutic equivalence. A set of guidelines are proposed to critically review clinical trials to determine whether there is sufficient evidence to conclude that an experimental therapy is therapeutically equivalent to a standard one. These guidelines include criteria for assessing whether
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Therapeutic Equivalence and Bioequivalence

Journal of the Korean Medical Association, 1999
Sang Goo Shin, Dong-Ryul Sohn
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Therapeutic equivalents in clinical practice.

International journal of fertility and women's medicine, 2001
With increasing debate over the rising expenses of health care, a variety of cost-saving measures has been attempted over the years. Use of primary care physicians as "gate keepers," reduction in the length of hospital stays, and pushing women toward vaginal birth after Cesarean section have all been utilized despite on going issues with patient ...
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TNT equivalency method in confined space based on steel plate deformation

International Journal of Impact Engineering, 2023
Xiangshao Kong, Hu Zhou, Zihan Zhu
exaly  

Therapeutic equivalence of mesalamine products.

Reviews in gastroenterological disorders, 2004
No bioequivalence studies have been conducted for mesalamine because of differences in formulation. Based on U.S. Food and Drug Administration definitions for bioequivalence, none of these drugs can be classified as bioequivalent or therapeutically equivalent.
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Therapeutic Equivalence of Lansoprzole and Esomeprazole

Clinical Drug Investigation, 2002
Colin Howden   +2 more
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