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Translation of research findings back to clinical care is facilitated through the development of clinical decision support dosing platforms that can be integrated within the electronic medical record, allowing real-time precision dosing at the point of care.
In either case, considerations of size, maturation, organ function, and disease state must be incorporated within the testing scenario to support dosing targets across regulatory‐defined age strata.
It is clear that resources to support dosing guidance are viewed as valuable.
The experimental effort needed to support dosing recommendations in children should be relative to the uncertainty that exists about likely drug effects in this population at the time a PIP is designed.
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A half-life of 14 days supports dosing every 28 days in future long-term trials.
Industry, regulators, and academia were aligned in that M&S is an important tool to support dose-regimen selection for a target population as well as to dosing recommendations for an untested population/clinical condition (see Table 2 in ref. ).
An acidic pH of 3.72 and 5.48, an initial chromium concentration of 10 and 16.91 mg/L and a support dose of 6.95 and 8.20 g/L were optimal for Cr VI) and total Cr removal, respectively.
Moreover, it could support dose selection of MCHR1 antagonists in drug development [7].
The ESR wishes to promote establishment of dose repositories to support dose management and clinical audit to document improvement.
A MCHR1-positron emission tomography (PET) ligand could support dose selection of MCHR1 antagonists [7] and, therefore, would be a valuable tool for drug development.
Our limited data do not support dose-dependent effects of lidocaine within the limited range used in our study, which is in line with previous studies [36].
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