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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 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 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.
Grzegorz, Cessak +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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A note on statistical methods for assessing therapeutic equivalence
Controlled Clinical Trials, 2002The two one-sided tests procedure and the confidence interval approach are two commonly used statistical approaches for testing therapeutic equivalence or assessing bioequivalence. However, some confusion arises. For example, what is the difference between the two approaches, given the fact that in some cases the two approaches produce the same test ...
Shein-Chung, Chow, Jun, Shao
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[Bioequivalence and therapeutic equivalence in psychiatry].
L'Encephale, 2004Many psychotropics on the market are generic forms and essentially similar products. Bioequivalence is the method used in order to demonstrate the therapeutic equi-valence between the reference drug and the new product. The principles, methods and limits of these studies are presented and illustrated by some examples for CNS drugs.
C, Couprie, , Lacarelle, , Blin
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Relexicalization and Instantial Equivalence in Conjoint Therapeutic Discourse
Textus, 1996Analysis using corpus linguistics techniques of repetition, relexicalisation and the phenomenon of instantial equivalence in an audio-recorded corpus of marital therapy encounters involving an interracial couple (Playback corpus, D. Fanshel)
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Biologic Availability and Therapeutic Equivalence
The Journal of Clinical Pharmacology, 1976J D, Arnold, J, Sicé
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