Results 21 to 30 of about 26,646 (226)
Clinical Pharmacology & Therapeutics: Past, Present, and Future. [PDF]
, 2017 Clinical Pharmacology & Therapeutics (CPT), the definitive and timely source for advances in human therapeutics, transcends the drug discovery, development, regulation, and utilization continuum to catalyze, evolve, and disseminate discipline ...
Terzic, Andre, Waldman, Scott A.
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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
doaj +1 more source
Therapeutic Drug Monitoring and Methods of Quantitation for Carbamazepine [PDF]
, 2017 Carbamazepine is an early anticonvulsant still used today in the treatment of several forms of epilepsy. An active metabolite in the human body contributes to its pharmacological effect.
Ana Vlasceanu +7 more
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Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease [PDF]
, 2013 The aim of the study was to characterize pharmacokinetics of tiotropium solution 5 µg compared to powder 18 µg and assess dose-dependency of tiotropium solution pharmacodynamics in comparison to placebo.
Cornelissen, PJG +7 more
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Качественная клиническая практика, 2020 Predicting the results of bioequivalence studies is an urgent and important task in developing protocols for clinical studies of bioequivalence. Objective: to develop an algorithm for predicting bioequivalence results based on factors with a sufficient ...
Dmitry P Romodanovsky +1 more
doaj +1 more source
Low-level seaweed supplementation improves iodine status in iodine-insufficient women [PDF]
, 2014 Iodine insufficiency is now a prominent issue in the UK and other European countries due to low intakes of dairy products and seafood (especially where iodine fortification is not in place).
Combet, Emilie +4 more
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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 +1 more source
Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry [PDF]
, 2010 Patent holders frequently attempt to mitigate the loss of monopoly power by authorizing generic entry prior to patent expiry (early entry). Competition in off-patent pharmaceutical markets may be adversely affected if early entry substantially impairs ...
Appelt, Silvia
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Frontiers in PharmacologyPhenytoin is a first-line antiepileptic drug with narrow therapeutic range and follows non-linear pharmacokinetics. Pharmacokinetics of phenytoin have been studied in plasma matrix before, however, there were several disadvantages.
Yahdiana Harahap +3 more
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Optimal testing of equivalence hypotheses
, 2005 In this paper we consider the construction of optimal tests of equivalence hypotheses. Specifically, assume X_1,..., X_n are i.i.d. with distribution P_{\theta}, with \theta \in R^k. Let g(\theta) be some real-valued parameter of interest.
Romano, Joseph P.
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