Objectives: To summarise all adverse events (AE), vital signs, electrocardiograms (ECG), and lab measurements for healthy subjects receiving placebo in…
Read morePoster: Drug/Disease modeling - Safety
Development of a Mechanism Based Platform to Predict Cardiac Contractility and Hemodynamics in Conscious Dogs
Objectives: Cardiovascular safety is one of the most frequent causes of safety related attrition both pre-clinically and clinically. Much progress has…
Read moreIntegrated Data Mining and Systems Pharmacology to Explore the Comparative Safety of Brand-Name and Generic Drugs
Objectives: Antiepileptic drugs (AEDs) have recently been at the epicenter of the controversy over generic-brand drug substitution due to purported lack…
Read moreFacilitate treatment adjustment after accidental overdosing: pharmacometric modelling to support clinical practice
Objectives: Accidental once or repeated overdosing is a frequent and potentially fatal clinical situation affecting paediatric and adult patients [1],[2]….
Read moreTime-to-event (TTE) modelling in drug safety evaluation: a case study
Objectives: The no-observed-adverse-effect level (NOAEL) of a drug defined from animal studies is crucial for inferring a maximal safe dose in…
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