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The primary aim of this study was to evaluate the ability of rodent-only toxicology studies to identify a safe phase I trial starting dose.
Given that the THA is safe, phase B studies must be conducted to evaluate the clinical performance of the THA regarding pain relief and functioning (clinical scores and patient-reported outcome measures (PROMS)) and to determine the rate of complications within a limited period that is feasible (e.g. severe adverse effects of the implant).
A recent review of the data on the first 25 compounds to be studied (Newell et al, 1999) confirmed that rodent-only toxicology provides a safe Phase I trial starting dose and predicts toxicity for the vast majority of the agents investigated.
Once the THP is considered safe, phase B studies must be conducted to evaluate the clinical performance of the THP regarding pain relief and functioning (clinical scores and patient-reported outcome measures (PROMS)) and to determine the rate of other complications (e.g. pseudotumors) (Pandit et al. 2008).
The aim of the study was to determine the maximum tolerated dose (MTD), the dose limiting toxicity (DLT), and the pharmacokinetic profile (Pk) of bendamustine (BM) on a day 1 and 2 every 3 weeks schedule and to recommend a safe phase II dose for further testing.
If the TKP is considered safe, phase B studies should be conducted to evaluate the clinical performance of the TKP regarding pain relief and functioning (clinical scores and patient-reported outcome measures (PROMS)) and to determine the rate of expected or unexpected complications.
Similar(53)
Hog1 uses several molecular strategies, alone or in combination, to arrest cells at safer phases in the cell cycle until an osmotic balance is re-established.
Thus demolition of buildings is now a well-planned part of civil engineering, with many aspects to ensure a safe demolition phase.
Nonhuman antibodies from, for instance, birds and primates, have been safely administered to people in the past, so human antibodies are expected to prove safe in phase 1 clinical trials, says reproductive physiologist Eddie Sullivan of SAB Biotherapeutics, who headed the project to develop the transchromosomal cows.
However, the validity of this model is undermined by the observation that a S. Typhi phoP mutant, which has no growth defect, is just as virulent as wild-type strains [92] in this model despite the fact that both S. Typhi and S. Typhimurium ΔphoPQ mutants have been shown to be safe in Phase I clinical trials [18], [93].
Ethyl pyruvate is a widely used as a food additive and was shown to be safe in phase I clinical trials.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com