Results 241 to 250 of about 2,032,347 (297)
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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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On Therapeutic Equivalency and the Antisubstitution Laws
JAMA: The Journal of the American Medical Association, 1973The comparative bioavailability of a drug in similarly formulated preparations is becoming a subject of considerable interest and importance to the physician. Drugs usually are not administered as pure compounds but are combined with materials such as binders, excipients, lubricants, preservatives, or other substances generally considered to be ...
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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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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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Methodological standards for assessing therapeutic equivalence
Journal of Clinical Epidemiology, 1991This 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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[The concept of therapeutic equivalence].
Medizinische Klinik (Munich, Germany : 1983), 1997Usually, it is the purpose of a clinical trial to demonstrate the superiority of a (new) treatment in comparison to another treatment with regard to a well-defined criterion of efficacy. However, other aspects rather than improved efficacy might be regarded as advantages of a new therapy, i.e.
S, Lange, J, Windeler
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Therapeutic reliability of variously manufactured drugs: Generic-therapeutic equivalence
The Journal of Pediatrics, 1970U N T I L recently we were in blissful ignorancC if we believed that all dosage forms of a particular drug could be expected to deliver the active ingredient to patients in an equivalent fashion. If this were so; we could ignore dosage form and use tablets, capsules, syrups, or elixirs interchangeably.
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Clinical and statistical issues in therapeutic equivalence trials
European Journal of Clinical Pharmacology, 1993Absolute proof of efficacy can only be given by placebo controlled trials. It is, however, important to classify a drug within the spectrum of existing therapeutic alternatives and, where effective treatment is available, it may be imperative due to ethical considerations to demonstrate that one drug is as effective as another. The issue of therapeutic
E, Garbe, J, Röhmel, U, Gundert-Remy
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Therapeutic equivalence of antipsychotics and antidepressants – A systematic review
Pharmacological Reports, 2016The number of newly approved generic psychotropic drugs increases every year and, in many countries, their sales exceed the sales of brand-name counterparts. In order for any generic drug to receive an approval of regulatory authorities, its bioequivalence with the corresponding reference product must be demonstrated.
Cessak, Grzegorz +6 more
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Therapeutic Equivalency of Low-Molecular-Weight Heparins
Annals of Pharmacotherapy, 2002OBJECTIVE: 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 ...
Gary M, McCart, Steven R, Kayser
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