The workshop determined that in keeping with the FDA guidance a comprehensive battery of tests for alternative etiologies of liver injury should be performed (see Table 3).
The mode of data collection (e.g., paper, electronic, internet, interactive voice response system, or interviewer-administered) must demonstrate measurement properties in keeping with the PRO guidance principles.
Venous thromboembolism prophylaxis changed during the study period from mechanical and aspirin to extended tinzaparin, in keeping with the evolving NICE guidance.
With 7034 patients enrolled and treated, the trial is in keeping with the 2008 FDA guidance on evaluating the CV risk of new therapies to treat T2DM [ 9] but may also provide insights beyond CV safety, including impact on microvascular, in particular renal outcomes, as detailed above.
Then, within a hundred and fifty days, the heads of agencies will explain what they are doing in keeping with that guidance.
In keeping with the general principles that are outlined in the guidance, should clinically serious hepatotoxicity turn out later to be causally linked to the study drug, banked DNA samples can be retrieved and analyzed to identify predictive biomarkers of increased susceptibility to DILI.
This guidance is in keeping with the Indian Constitution, which provides for equality for all (article 14) and prohibits discrimination on the grounds of religion, race, caste, sex or place of birth (article 15).
In keeping with the neuronal maturation defect, we find PTBP2 target exons in many transcripts affecting neurite outgrowth, axon guidance, synaptic assembly, and synaptic function.
