Therapeutic Innovation & Regulatory Science, 2016
Stewart J, Breslin WJ, Beyer BK, Chadwick K, De Schaepdrijver L, ...
- HESI - Health and Environmental Sciences Institute
The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials.
British Journal of Pharmacology, 2017
Park EJ, Gintant GA, Bi D, Kozeli D, Pettit SD, Pierson JB, ...
- HESI - Health and Environmental Sciences Institute
The strengths and limitations of three nonclinical repolarization assays used to define the risk of clinical drug-induced delayed ventricular repolarization (a surrogate marker of the rare but potentially lethal arrhythmia Torsades de Pointes) were compared during a retrospective analysis of an anonymized database of 150 ...
Toxicological Sciences, 2020
Roberts R, Authier S, Mellon D, Morton M, Suzuki I, Tjalkens RB, ...
Seizure liability remains a significant cause of attrition in drug discovery and development, leading to loss of competitiveness, delays and increased costs. Current detection methods rely on observations made in in vivo studies intended to support clinical trials, such as tremors or other abnormal movements. These signs ...
Journal of Pharmacological and Toxicological Methods, 2017
E. Boulay, M.K. Pugsley, V. Jacquemet, A. Vinet, M.V. Accardi, ...
- HESI - Health and Environmental Sciences Institute
Heart rate correction methods are frequently used when analyzing data collected during the drug development process to better understand the QT interval. There is variability in this methodology and the optimal heart rate correction formula is often debated. This paper details a study that explored the ...
International Journal of Toxicology, 2011
Sarazan RD, Mittelstadt S, Guth B, Koerner J, Zhang J, Pettit S
- HESI - Health and Environmental Sciences Institute
There are several recent examples where clinically significant, safety-related, drug effects on hemodynamics or cardiac function were not apparent until large clinical trials were completed or the drugs entered the consumer market.
Advanced Drug Delivery Reviews, 2014
Forbes B, O'Lone R, Allen PP, Cahn A, Clarke C, Collinge M, ...
- HESI - Health and Environmental Sciences Institute
Alveolar macrophage (AM) responses are commonly induced in inhalation toxicology studies, typically being observed as an increase in number or a vacuolated ‘foamy’ morphology.
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