Results 221 to 230 of about 8,110,163 (275)
Some of the next articles are maybe not open access.
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 ...
openaire +1 more source
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 ...
openaire +1 more source
Safety Assessment Versus Efficacy Assessment
2007Many 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.
openaire +1 more source
Probabilistic Safety Assessment
2015Probabilistic 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
openaire +1 more source
Sensing advancement towards safety assessment of hydrogen fuel cell vehicles
, 2021S. Foorginezhad +5 more
semanticscholar +1 more source
Critical care management of chimeric antigen receptor T‐cell therapy recipients
Ca-A Cancer Journal for Clinicians, 2022Alexander Shimabukuro-Vornhagen +2 more
exaly
An overview of real‐world data sources for oncology and considerations for research
Ca-A Cancer Journal for Clinicians, 2022Lynne Penberthy +2 more
exaly
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.
openaire +1 more source
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.
openaire +1 more source
Application of new approach methodologies for nonclinical safety assessment of drug candidates
Nature reviews. Drug discoveryM. Beilmann +10 more
semanticscholar +1 more source
A New Safety Assessment Method Based on Belief Rule Base With Attribute Reliability
IEEE/CAA Journal of Automatica Sinica, 2020Zhichao Feng +5 more
semanticscholar +1 more source