Results 191 to 200 of about 5,193 (248)

The therapeutic equivalence of complex drugs

Regulatory Toxicology and Pharmacology, 2011
When 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, Klinger, Ety, Mühlebach, Stefan, Brin, Jean-Francois, Storm, Gert, Crommelin, Daan J. A.   +5 more
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Therapeutic equivalency of procainamide—A correction

American Journal of Cardiology, 1991
exaly   +2 more sources

On the Definition of Therapeutic Equivalence

Drug Information Journal, 2000
What do we mean by therapeutic equivalence and how do we prove that two drugs are therapeutically equivalent? We suggest that therapeutic equivalence should be defined and demonstrated using predefined limits on the dose scale rather than on the effect scale.
Anders Källén, Per Larsson
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Therapeutic equivalence: fallacies and falsification

Statistics in Medicine, 2003
AbstractThe 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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GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE

JAMA: The Journal of the American Medical Association, 1968
In 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, 1973
The 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, 1976
Twenty-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, I W, Wainer, D M, Hemphill   +2 more
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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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[The concept of therapeutic equivalence].

Medizinische Klinik (Munich, Germany : 1983), 1997
Usually, 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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