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Robust meta-analytic-predictive priors in clinical trials with historical control information.
TLDR
We address this challenge by deriving a Bayesian meta-analytic-predictive prior from historical data, which is then combined with new data. Expand
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Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts.
TLDR
In this paper we focus on the description of flexible test procedures allowing for adaptively selecting hypotheses at interim and thus allowing the combination of learning and confirming in a single seamless trial. Expand
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A faunistic approach to assess potential side-effects of genetically modified Bt-Corn on non-target arthropods under field conditions
A faunistic study investigating the potential side-effects of corn (Zea mays) genetically modified to express a truncated Cry1Ab protein derived from Bacillus thuringiensis subsp. kurstaki, onExpand
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Pharmacokinetics and Pharmacodynamics of the Novel Daily Rivastigmine Transdermal Patch Compared With Twice‐daily Capsules in Alzheimer's Disease Patients
A transdermal patch has been developed for the cholinesterase inhibitor rivastigmine. This study investigated the pharmacokinetics and pharmacodynamics of rivastigmine and NAP226–90, and comparedExpand
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Therapeutic drug monitoring for everolimus in kidney transplantation using 12‐month exposure, efficacy, and safety data
Abstract:  The aims of the current study were to determine whether therapeutic drug monitoring (TDM) might benefit kidney transplant recipients receiving everolimus, and to establish dosageExpand
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Everolimus Therapeutic Concentration Range Defined from a Prospective Trial with Reduced-Exposure Cyclosporine in De Novo Kidney Transplantation
Prospective therapeutic drug monitoring of everolimus was performed in a 1-year multicenter trial in 237 de novo kidney transplant patients. Trough blood levels, rejection episodes, and safetyExpand
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Pharmacokinetics and electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet) with concomitant administration of ketoconazole in healthy subjects.
AIMS To evaluate whether the potent CYP3A4 inhibitor ketoconazole has any influence on the pharmacokinetic and electrocardiographic parameters of the antimalarial co-artemetherExpand
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Population pharmacokinetics of imatinib mesylate in patients with chronic-phase chronic myeloid leukaemia: results of a phase III study.
AIMS This study was designed to investigate the biochemical and physiological covariates or comedications that affect the pharmacokinetics of imatinib mesylate in patients with chronic-phase chronicExpand
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Therapeutic Drug Monitoring for Everolimus in Heart Transplant Recipients Based on Exposure–Effect Modeling
Everolimus, a proliferation signal inhibitor, is an immunosuppressant that targets the primary causes of progressive allograft dysfunction, thus improving the long‐term outcome after heartExpand
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Blinded sample size reestimation with count data: methods and applications in multiple sclerosis.
Sample size estimation in clinical trials depends critically on nuisance parameters, such as variances or overall event rates, which have to be guessed or estimated from previous studies in theExpand
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