Results 11 to 20 of about 9,364 (186)
Bioequivalence studies in Morocco
The Pan African Medical Journal, 2020 The development of the generic drug represents one of the strongest axes of the regulation of drug expenditure. In addition to saving the cost of the medical treatment that it allows, it has other interests.
Sanaa Zaoui, Wafaa Fadili
doaj +4 more sources
Drugs in R&D, 2023 Background and Objectives Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development.
Dejan Krajcar +4 more
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Application in silico Modeling Simulation in Bioequivalence Studies: A Review
Journal of Food and Pharmaceutical Sciences, 2023 Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies ...
Sekar Ayu Pawestri
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Data in Brief, 2016 The efavirenz pharmacokinetic raw data presented in this article was obtained in an average bioequivalence study between a local brand and Stocrin (Merck Sharp & Dohme, purchased from Australia, batch H009175, expiration date November 2013).
Manuel Ibarra +4 more
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New Bioequivalence Studies : Individual Bioequivalence and Population Bioequivalence
YAKUGAKU ZASSHI, 2000 The bioequivalence study which is currently conducted in different countries is the so-called average bioequivalence approach; this approach has been indicated to be insufficient for assessing switchability between two formulations (i.e., from the reference formulation to the test formulation).
NAKAI, Kiyohito +2 more
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Indicators of Evidence for Bioequivalence [PDF]
Entropy, 2016 Some equivalence tests are based on two one-sided tests, where in many applications the test statistics are approximately normal. We define and find evidence for equivalence in Z-tests and then one- and two-sample binomial tests as well as for t-tests. Multivariate equivalence tests are typically based on statistics with non-central chi-squared or non ...
Stephan Morgenthaler, Robert G. Staudte
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Relevant Issues of Planning Bioequivalence Studies of Drugs with a Narrow Therapeutic Range
Регуляторные исследования и экспертиза лекарственных средств, 2020 In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivalence or therapeutic equivalence studies. In most cases, comparative pharmacokinetic studies and demonstration of bioequivalence between the test and the ...
D. P. Romodanovsky
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CPT: Pharmacometrics & Systems Pharmacology, 2022 Among the current approaches for the analysis of bioequivalence, the average bioequivalence (ABE) is limited only to the mean bioavailability, whereas the population bioequivalence (PBE) criterion aggregates both mean and variance in a general comparison
Sara Soufsaf, Fahima Nekka, Jun Li
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Регуляторные исследования и экспертиза лекарственных средств, 2018 The article analyses regulatory documents and requirements for statistical principles of planning and evaluation of results of bioequivalence studies. It describes current statistical approaches to bioequivalence evaluation and relevant recommendations ...
D. P. Romodanovsky +3 more
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Journal of Pharmacy & Pharmaceutical Sciences, 2017 The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January ...
Paramjeet Kaur +2 more
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