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Providing efficacy and some safety is established, it could be feasible to move to provisional approval pending collection of more safety and tolerability data.
The peptide molecular identification and solution concentrations are also confirmed during analytical validation; their safety is established through GLP (good laboratory practices) toxicological studies.
A moratorium on the use of etomidate in critically ill patients outside clinical trials may be prudent until its safety is established.
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Its safety was established in a thorough clinical development program.
Although fibrate monotherapy alone or in combination with non-statin low-density lipoprotein cholesterol-lowering agents can be effective in mixed hyperlipidemia when statins are not tolerated, the combination of statin + fibrate should be considered second-line therapy until the efficacy and safety are established.
Dose escalation occurred after safety was established for at least 14 days from the previous cohort.
Only through head-to-head controlled clinical trials can differences in efficacy and safety be established.
Antiviral activity and safety was established in a Phase IIa trial that randomized 47 antiretroviral-naïve adult males to rilpivirine monotherapy or placebo.
Conversely, snails consider the evangelist insistence on implementing innovative medical procedures before their efficacy and safety are established as morally unjustified precisely because even reasonable-seeming interventions can waste scarce resources, introduce ineffective, inefficient and potentially even harmful changes in care, and generate serious opportunity costs.
The modeling approaches for various loads and responses using SHM data are proposed and the framework of SHM-based structure safety evaluation is established.
This safety profile is established during pre-clinical development through in vitro assays and animal studies.
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CEO of Professional Science Editing for Scientists @ prosciediting.com