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Proof of Pharmacology, Safety, and Pharmacokinetics of the Novel TRPA1 Antagonist BI 1839100: A Randomized, Placebo-Controlled, Parallel Group, First-In-Human Study in Healthy Male Participants. [PDF]
van Ruissen MCE+6 more
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Dose-response relationship and incidence of adverse drug reactions with isradipine in patients with essential hypertension [PDF]
Based on pooled data from three randomized placebo-controlled dose-finding studies in a total of 489 patients, the dose-response relationship for efficacy and adverse events was estimated, using the Michaelis-Menten equation: Effect = maximal effect multiplied by dose/constant plus dose. Three conclusions were derived from the pooled data: (1) A marked
K. Simonsen, Carl-David Sundstedt
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An Alternate Method for Estimating the Dose-Response Relationships of Neuromuscular Blocking Drugs
Anesthesia & Analgesia, 2000Slopes of the dose-response relationships for all available neuromuscular blocking drugs appear to be essentially parallel and to approximate a log-dose/logit value of 4.75. We tested the possibility of estimating both 50% effective dose (ED(50)) and 95% effective dose (ED(95)) values from a single dose-response data point when that slope is postulated.
George G. Neuman+2 more
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The multiple propensity score for analysis of dose–response relationships in drug safety studies
Pharmacoepidemiology and Drug Safety, 2001AbstractIn order to detect adverse drug reactions, large observational drug safety studies are necessary as randomized clinical trials rarely have enough power. However, in order to obtain reliable results the issue of confounding, especially confounding by indication, should be addressed.
Wang, Jixian+3 more
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Dose‐response relationship characterization in current anti‐hypertensive drug development
Clinical Pharmacology & Therapeutics, 2003Clinical Pharmacology & Therapeutics (2003) 73, P68–P68; doi:
R. J. Lipicky, Jogarao V. S. Gobburu
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Journal of Biopharmaceutical Statistics, 2015
Clinical trials often involve comparing 2-4 doses or regimens of an experimental therapy with a control treatment. These studies might occur early in a drug development process, where the aim might be to demonstrate a basic level of proof (the so-called proof of concept (PoC) studies), at a later stage, to help establish a dose or doses that should be ...
Amy Racine, David Ohlssen
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Clinical trials often involve comparing 2-4 doses or regimens of an experimental therapy with a control treatment. These studies might occur early in a drug development process, where the aim might be to demonstrate a basic level of proof (the so-called proof of concept (PoC) studies), at a later stage, to help establish a dose or doses that should be ...
Amy Racine, David Ohlssen
openaire +3 more sources