Results 261 to 270 of about 3,107,552 (340)
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AAPS PharmSciTech, 2019
Brazil has established a framework for provision of generic pharmaceuticals including for orally inhaled and nasal drug products (OINDP) to its populace.
Marcia Cavallin Silva +5 more
semanticscholar +1 more source
Brazil has established a framework for provision of generic pharmaceuticals including for orally inhaled and nasal drug products (OINDP) to its populace.
Marcia Cavallin Silva +5 more
semanticscholar +1 more source
Journal of Pharmacy and Science, 2018
The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing and one-size-fits-all regulatory criteria, this new ...
Rodrigo Cristofoletti +5 more
semanticscholar +1 more source
The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing and one-size-fits-all regulatory criteria, this new ...
Rodrigo Cristofoletti +5 more
semanticscholar +1 more source
Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran.
Canadian Journal of Cardiology, 2018Dabigatran is widely used for stroke prevention in atrial fibrillation. Dabigatran is no longer patent-protected in Canada and 2 generic formulations were recently approved by Health Canada.
J. Weitz +4 more
semanticscholar +1 more source
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 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 identify English-language literature available on enoxaparin, dalteparin, ardeparin, and tinzaparin.
Gary M, McCart, Steven R, Kayser
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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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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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