首页|Prediction of clinical risks by analysis of preclinical and clinical adverse events
Prediction of clinical risks by analysis of preclinical and clinical adverse events
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NSTL
Elsevier
This study examines the ability of nonclinical adverse event observations to predict human clinical adverse events observed in drug development programs. In addition it examines the relationship between nonclinical and clinical adverse event observations to drug withdrawal and proposes a model to predict drug withdrawal based on these observations. These analyses provide risk assessments useful for both planning patient safety programs, as well as a statistical framework for assessing the future success of drug programs based on nonclinical and clinical observations.
BayesianTranslational medicineAnimal-human concordanceAdverse eventsDrug riskLikelihood ratio
Clark, Matthew
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Elsevier Life Sci Solut, 1600 John F Kennedy Blvd,Suite 1800, Philadelphia, PA 19103 USA
NSTL
Elsevier
