Search results for "Confidence Interval"
showing 10 items of 1297 documents
Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles
2021
Abstract Background and objectives: The most widely used method to compare dissolution profiles is the similarity factor f 2 . When this method is not applicable, the confidence interval of f 2 using bootstrap methodology has been recommended instead. As neither details of the estimator nor the types of confidence intervals are described in the guidelines, the suitability of five estimators and fourteen types of confidence intervals were investigated in this study by simulation. Methods: One million individual dissolution profiles were simulated for the reference and test populations with predefined target population f 2 values, where random samples of different sizes were drawn without rep…
Comparison of free software platforms for the calculation of the 90% confidence interval of f2 similarity factor by bootstrap analysis
2020
Abstract Introduction The calculation of the 90% confidence interval of f2 based on the bootstrap methodology has been proposed and accepted by the main regulatory authorities when the dissolution data shows excessive variability. Different free software platforms allow the calculation of the 90% CI of f2 by means of bootstrapping. Their use in regulatory submissions is growing, but divergent results have been observed between the available software platforms. Therefore, the objective of this work is to analyze the characteristics of these software platforms and evaluate their results. Methods and materials Highly variable in vitro dissolution data from two products were selected. Three dif…
Adverse events as potential predictive factors of activity in patients with advanced hepatocellular carcinoma treated with lenvatinib
2021
Background and Aim: Lenvatinib is a standard of care option in first-line therapy of advanced hepatocellular carcinoma (HCC). In the present study, we aim to identify, in patients with HCC treated with lenvatinib, a possible association between occurrence and grading of adverse events (AEs) and outcome. Methods: We performed a retrospective analysis of 606 Japanese and Italian patients treated with lenvatinib in first-line setting and investigated the possible correlation between the onset of AEs, toxicity grade (G) and outcome measures such as overall survival (OS) and progression-free survival (PFS). Results: The appearance of arterial hypertension G ≥ 2 independently predicted prolonged …
Search for the decayB+→Ks0Ks0π+
2009
We search for charmless decays of charged B mesons to the three-body final state (KSKS0)-K-0 pi(+). Using a data sample of 423.7 fb(-1) collected at the Gamma(4S) resonance with the BABAR detector, corresponding to (465.1 +/- 5.1) x 10(6) (B) over bar B pairs, we find no significant signal and determine a 90% confidence level upper limit on the branching fraction of 5.1 x 10(-7).
ACTINIDE AND ULTRA-HEAVY ABUNDANCES IN THE LOCAL GALACTIC COSMIC RAYS: AN ANALYSIS OF THE RESULTS FROM THELDEFULTRA-HEAVY COSMIC-RAY EXPERIMENT
2012
The LDEF Ultra-Heavy Cosmic-Ray Experiment (UHCRE) detected Galactic cosmic rays (GCRs) of charge Z ≥ 70 in Earth orbit with an exposure factor of 170 m2 sr yr, much larger than any other experiment. The major results include the first statistically significant uniform sample of GCR actinides with 35 events passing quality cuts, evidence for the existence of transuranic nuclei in the GCR with one 96Cm candidate event, and a low 82Pb/78Pt ratio consistent with other experiments. The probability of the existence of a transuranic component is estimated as 96%, while the most likely 92U/90Th ratio is found to be 0.4 within a wide 70% confidence interval ranging from 0 to 0.96. Overall, the resu…
New information on β-delayed neutron emission from Be-12, Be-14
1999
17 pages, 3 tables, 5 figures, 1 appendix.-- PACS nrs.: 23.40.Hc; 27.20.+n.
Search for the Rare Decay B→πl+l−
2007
We have performed a search for the flavor-changing neutral-current decays B → π ℓ + ℓ − , where ℓ + ℓ − is either e + e − or μ + μ − , using a sample of 230 × 10 6 Υ ( 4 S ) → B ¯¯¯ B decays collected with the BABAR detector. We observe no evidence of a signal and measure the upper limit on the isospin-averaged branching fraction to be B ( B → π ℓ + ℓ − ) < 9.1 × 10 − 8 at 90% confidence level. We also search for the lepton-flavor-violating decays B → π e ± μ ∓ and measure an upper limit on the isospin-averaged branching fraction of B ( B → π e ± μ ∓ ) < 9.2 × 10 − 8 at 90% confidence level.
Search for γγ→ηb in e+e− collisions at LEP 2
2002
A search for the pseudoscalar meson eta_b is performed in two-photon interactions at LEP~2 with an integrated luminosity of 699 pb^-1 collected at e+e- centre-of-mass energies from 181 GeV to 209 GeV. One candidate event is found in the six-charged-particle final state and none in the four-charged-particle final state, in agreement with the total expected background of about one event. Upper limits of Gamma_gammagamma(eta_b) * BR(eta_b -> 4 charged particles) 6 charged particles) < 132 eV are obtained at 95% confidence level, which correspond to 95% confidence level upper limits of 9.0% and 25% on these branching ratios.
X-ray variability of NGC 2516 stars in the XMM-Newton observations
2006
We present the characteristics of the X-ray variability of stars in the cluster NGC2516 as derived from XMM-Newton/EPIC/pn data. The X-ray variations on short (hours), medium (months), and long (years) time scales have been explored. We detected 303 distinct X-ray sources by analysing six EPIC/pn observations; 194 of them are members of the cluster. Stars of all spectral types, from the early-types to the late-M dwarfs, were detected. The Kolmogorov-Smirnov test applied to the X-ray photon time series shows that, on short time scales, only a relatively small fraction (ranging from 6% to 31% for dG and dF, respectively) of the members of NGC2516 are variable with a confidence level $\geq$99%…
Statistical Analysis of a Method to Predict Drug–Polymer Miscibility
2015
In this study, a method proposed to predict drug-polymer miscibility from differential scanning calorimetry measurements was subjected to statistical analysis. The method is relatively fast and inexpensive and has gained popularity as a result of the increasing interest in the formulation of drugs as amorphous solid dispersions. However, it does not include a standard statistical assessment of the experimental uncertainty by means of a confidence interval. In addition, it applies a routine mathematical operation known as "transformation to linearity," which previously has been shown to be subject to a substantial bias. The statistical analysis performed in this present study revealed that t…