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Assessment and Safety

2015
More and more young people practice climbing at a higher and higher level. Trying to reach excellence implies a rise in the number of training sessions and in the duration of these sessions, which consequently leads to an increase in injuries. Most of the common pathologies are found with high-level climbing.
Sébastien Gnecchi, François Moutet
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Assessment of Safety

2020
In most clinical trials in phase II and III, the primary endpoint measures efficacy and therefore sample size calculation is based on this outcome. However, there are also situations were the primary objective concerns safety. Furthermore, even if sample size calculation is based on an efficacy endpoint, one is commonly interested which extent of ...
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Safety Assessment Versus Efficacy Assessment

2007
Many statistical methods have been developed that focus primarily on efficacy. Safety evaluation frequently involves many additional considerations. Randomized controlled trials, especially later phase 3 trials, are infrequently designed based on safety outcomes.
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Probabilistic Safety Assessment

2015
Probabilistic safety/risk assessment provides a quantitative framework to estimate risk and identify risk contributors. This chapter introduces the concept of risk and gives an overview of probabilistic safety assessment steps. Special emphasis is given to event tree analysis, importance measures, common cause failure analysis, and human reliability ...
Ajit Kumar Verma   +2 more
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Safety Assessments

2021
Eric J. Shappee, Graham Feasey
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Using human genetics to improve safety assessment of therapeutics

Nature Reviews Drug Discovery, 2022
Keren J Carss   +2 more
exaly  

An overview of real‐world data sources for oncology and considerations for research

Ca-A Cancer Journal for Clinicians, 2022
Lynne Penberthy   +2 more
exaly  

Nonclinical Safety Assessment

2013
Description: Bringing a new drug to market is a costly time–consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach.
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Safety Assessments

2019
Michael I. Ojovan   +2 more
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