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Besides the application of the standardised test methods, alternative test methods and endpoints for the assessment of ENMs are published.
By EUCAST and CLSI susceptibility testing, isavuconazole MICs for the Mucorales isolates were similar to those found for Aspergillus species, with the exception of Mucor circinelloides, which was notably less susceptible than the other species across all methods and endpoints (13, 29).
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EFSA [8] assessed the study [3] with regard to five criteria: study objectives, study design, feed and treatment formulation, statistical methods, and endpoint reporting.
Variations in antigen preparation and purity, assay methods, and endpoint determination between laboratories and the absence of a suitable standard reference serum compound this problem.
It is a well-known phenomenon that MICs rise with extended time of incubation and also that MIC endpoints may vary considerably across methods and endpoint criteria in general and also specifically for isavuconazole and Mucorales (32).
A VHX trial investigator was responsible for explaining the purpose of the trial and its methods, processes, and endpoints.
A variety of methods and measurement endpoints are currently available for evaluating respiratory function in animal models.
The objective of this review is to discuss the value and utility of the methods and measurement endpoints currently available for assessing respiratory function to help optimize the design of respiratory safety pharmacology studies.
Importantly, most trials have important methodological flaws and have used inconsistent methods and therapeutic endpoints [29].
Importantly, most trials have important methodological flaws and have used inconsistent methods and therapeutic endpoints [ 29].
A more sophisticated approach was taken by Sullender et al. [126], who used simulation (without accounting for uncertainty) from a model built to describe the PK of an oral aciclovir suspension to show that intravenous dosing would be required to achieve target IC50 values although full details on the in vitro methods and PD endpoints are lacking in these studies.
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