Relevant Issues of Planning Bioequivalence Studies of Drugs with a Narrow Therapeutic Range
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چکیده
منابع مشابه
Bioequivalence and interchangeability of narrow therapeutic range drugs. Canadian Society for Pharmaceutical Sciences discussion.
A Canadian Society for Pharmaceutical Sciences (CSPS) discussion group was held on August 23, 1997 in Edmonton, Alberta to discuss issues surrounding the bioequivalence of narrow therapeutic range (NTR) drugs. Participants in the discussion presented on topics related to sources of variability attributed to subject, target patient response and manufacturing as well as regulatory issues. This do...
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The US Food and Drug Administration (FDA) has recently suggested that the bioequivalence (BE) for products of drugs with narrow therapeutic indices (NTI) be assessed by the approach of reference-scaled average BE (SABE). Subsequently, in December, 2012, the FDA issued draft guidances for the comparison of products of warfarin sodium and of tacrolimus. The guidances expect that 4-period studies ...
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PURPOSE The purpose of this computer simulation was to determine the likelihood of two bioequivalent (vs. reference) generic warfarin formulations (with varying bioavailability) passing current bioequivalence criteria against each other at varying bioavailability. Methods. A bioequivalence simulation program generated 100 warfarin bioequivalence (BE) studies with 24 patients/study. The referenc...
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Correspondence: E. Derom, Dept of Respiratory Diseases, University Hospital, De Pintelaan 185, B-9000 Gent, Belgium. It is generally accepted that inhalation therapy is the most effective way to treat patients with asthma or chronic obstructive pulmonary disease (COPD). Indeed, inhalation of relatively small doses of drug not only results in high, local concentrations in the airways the site of...
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The basic components of pharmacokinetics are absorption, distribution, metabolism, and excretion. During pregnancy there may be changes in one or many of these components. Early drug studies did not include a representative proportion of women, however, researchers as well as regulators agree that studies on the sex differences in the disposition of drugs are important, but at what stage in the...
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ژورنال
عنوان ژورنال: The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products
سال: 2020
ISSN: 2619-1172,1991-2919
DOI: 10.30895/1991-2919-2020-10-3-201-210