drexplorer: A tool to explore dose–response relationships and drug–drug interactions [PDF]
AbstractMotivation: Nonlinear dose–response models are primary tools for estimating the potency [e.g. half-maximum inhibitory concentration (IC) known as IC50] of anti-cancer drugs. We present drexplorer software, which enables biologists to evaluate replicate reproducibility, detect outlier data points, fit different models, select the best model ...
Pan, Tong +8 more
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Drug therapy: dose‐response relationship of oral mesalazine in inflammatory bowel disease [PDF]
Mesalazine is widely used in the treatment of inflammatory bowel disease. Little is known about the doseresponse relationship and about possible dose related side effects. In ulcerative colitis higher dosages of mesalazine (3 g) are more effective in maintaining a remission than lower dosages (1.5 g).
C. J. J. Mulder, S. J. Van Den Hazel
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Model Selection versus Model Averaging in Dose Finding Studies [PDF]
Phase II dose finding studies in clinical drug development are typically conducted to adequately characterize the dose response relationship of a new drug.
Bornkamp, Björn +3 more
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Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma : results from two phase 3, randomised, double-blind, placebo-controlled trials [PDF]
BACKGROUND: Reslizumab 3 mg/kg administered intravenously is approved for the treatment of severe eosinophilic asthma. We assessed the safety and efficacy of subcutaneous reslizumab 110 mg in two trials in patients with uncontrolled severe asthma and ...
Adir, Yochai +13 more
core +1 more source
Dose-response relationship in phase I clinical trials: A European Drug Development Network (EDDN) collaboration study. [PDF]
Abstract Introduction: Because a dose–response relationship is characteristic of conventional chemotherapy, this concept is widely used for the development of novel cytotoxic (CTX) drugs. However, the need to reach the MTD to obtain optimal benefit with molecularly targeted agents (MTA) is controversial.
Garcia VM +19 more
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Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity [PDF]
BACKGROUND: It is important to quantify the dose response for a drug in phase 2a clinical trials so the optimal doses can then be selected for subsequent late phase trials.
AE Raftery +17 more
core +2 more sources
The dose-response relationship for memory impairment by anticholinergic drugs
Twelve stabilized chronic schizophrenic outpatients receiving maintenance treatment with fluphenazine decanoate plus anticholinergic antiparkinsonian drugs underwent two challenge sessions receiving, in random sequence and double-blind, injections of either benztropine or glycopyrrolate (a peripherally active anticholinergic agent that penetrates the ...
J P, McEvoy, S, Freter
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Understanding and applying pharmacometric modelling and simulation in clinical practice and research [PDF]
Understanding the dose-concentration-effect relationship is a fundamental component of clinical pharmacology. Interpreting data arising from observations of this relationship requires the use of mathematical models; i.e.
Standing, JF
core +1 more source
Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. [PDF]
In part A of this study, patients were randomised to cohorts receiving darbepoetin alfa at doses of 0.5 to 8.0 m.c.g x kg(-1) x wk(-1) or to a control group receiving epoetin alfa at an initial dose of 150 U x kg(-1) three times weekly.
Armstrong, S +10 more
core +2 more sources
Pharmacokinetic-Pharmacodynamic and Dose-Response Relationships of Antituberculosis Drugs: Recommendations and Standards for Industry and Academia [PDF]
Antimicrobial pharmacokinetic-pharmacodynamic (PK/PD) science is vital to early antibiotic drug development to enable more efficient dose-effect study designs, identification of doses that may suppress drug resistance and choice of susceptibility breakpoints.
Gumbo, Tawanda +2 more
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