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Exact(4)
In the most sensitive study published to date, Nieto et al. utilized the highest sensitivity flow cytometry approaches available with the use of 8-color staining panels and the analysis of 5 million B cells per subject and identified an MBL prevalence of 14% among 608 healthy adults aged more than 40 years [ 3].
In case of drugs with non-saturated hepatic first-pass effect (and no gut-wall metabolism) the parent drug is usually the most sensitive analyte and the single dose design is usually the most sensitive study design to detect the worsening of the biopharmaceutic quality of the test formulation.
Furthermore, the most sensitive study from a large collection of studies will likely be more "conservative" than the most sensitive study from a smaller number of studies.
Results from DNT studies have also been used in calculating a chronic RfD for lifetime exposure to a toxicant when it has been shown to be the most sensitive study in the toxicology database.
Similar(56)
Importantly, the uncertainty associated with the identification of the critical studies and endpoints is difficult to quantify, and the usual (deterministic) approach of focusing on the most sensitive studies and endpoints is hard to avoid.
The choice of the 0.6 mg m−2 starting dose was based on in vivo toxicity studies (1 out of the 10 of the MTD from the most sensitive toxicity study).
Along chemistry community, Nuclear Magnetic Resonance NMRR) is one of the most widely used spectroscopic techniques, and the most sensitive to study organic compounds molecular structure [4 6].
To further explore the potential of using radioactive probes for OI, phantom imaging study was performed to determine the spatial resolutions of the three most sensitive radionuclides studied (18F, 131I and 90Y).
The objective of this work is to use a computer simulation approach to define the most sensitive analyte and study design of the in vivo bioequivalence study for all types of Biopharmaceutics Classification System (BCS) drugs undergoing first-pass hepatic metabolism under non-linear conditions.
Parent drug in single dose is the most sensitive analyte and study design for bioequivalence trials in almost all the studied scenarios.
In this analysis, the Jaimet and Thode (1955) 10-week, multiple dose human study of thyroid effects (decreased iodine uptake) in children was determined to be the most robust and sensitive study for identifying a potential point of departure dose (POD).
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