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We performed a multi-centre phase I study to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the orally available small molecule mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor, WX-554, and to determine the optimal biological dose for subsequent trials.
Compliance with the above procedures was checked via written logs of nutritional intake, and participants were asked to replicate nutritional practices for subsequent trials (adherence = 100%).
Among the concentrations of AS investigated (0, 50, 100, 200, and 400 μM), 200 μM was selected for subsequent trials because this concentration yielded the most transformants.
Phase I clinical trials are conducted to find recommended doses, where toxicity of the agent is typically assessed to determine what dose is appropriate for subsequent trials.
Additionally, participants were asked to replicate their diet during the first experimental visit for subsequent trials to ensure a similar metabolic state.
The data will go to the Food and Drug Administration and pharmaceutical companies; they, in turn, will use their own platforms for subsequent trials.
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We suggest that our methodology provides guidance for the analytical design of subsequent trials and that GHD severity GHRd3 stratification should be considered in future pharmacogenomic studies.
The trial established the "Nuremberg principles" – the foundation for all subsequent trials for crimes against the peace, war crimes, and crimes against humanity.
The new item on one trial became an old item for all subsequent trials.
The same definition was used for all subsequent trials after PROWESS.
The position on the cycle ergometer was determined prior to the habituation session, recorded and maintained for all subsequent trials.
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