Statistical Methodology Sample Clauses
The Statistical Methodology clause defines the specific statistical techniques and procedures that will be used to collect, analyze, and interpret data within the context of an agreement or project. It typically outlines the types of statistical tests, sampling methods, and data analysis protocols to be followed, ensuring that all parties use consistent and scientifically valid approaches. By clearly specifying these methods, the clause helps prevent disputes over data interpretation and ensures that results are reliable and reproducible.
Statistical Methodology. 4.1 For all submeasurements with benchmark standards (“benchmark submeasurements”), as designated in the PIDs, the determination of CenturyLink QC’s conformance with Plan and PID standards will involve comparing performance levels reported for submeasurements against benchmarks established in the PIDs on a “stare- and-compare” basis (i.e., with no additional statistical methodology applied).
4.2 For all submeasurements with parity standards (“parity submeasurements”), as designated in the PIDs, the determination of CenturyLink QC’s conformance with Plan and PID standards will involve comparing statistical z-scores associated with performance levels reported for submeasurements against statistical critical values as defined in Section 5.0. The calculation of z-scores will be based on a statistical test, called the “modified z- test,” as defined in Section 4.4 below, to determine whether a parity condition exists between the results for CenturyLink QC and for CLEC.
4.3 For the purpose of this Section, the CenturyLink QC results will be the CenturyLink QC monthly retail results as specified in the PIDs.
4.4 The modified z-test shall be applicable if the CLEC sample size is greater than 30 for a given submeasurement. The formula for determining parity using the z-test is: z = DIFF / σDIFF Where: DIFF = MCenturyLink QC – MCLEC MCenturyLink QC = CenturyLink QC average or proportion MCLEC = CLEC average or proportion σDIFF = square root [σ2 CenturyLink QC (1/ n CLEC + 1/ n CenturyLink QC)] σ2CenturyLink QC = Calculated variance for CenturyLink QC nCenturyLink QC = number of observations or samples used in CenturyLink QC submeasurement nCLEC = number of observations or samples used in CLEC submeasurement In calculating the difference between CenturyLink QC and CLEC performance, the above formula applies when a larger CenturyLink QC value indicates a better level of performance. In cases where a smaller CenturyLink QC value indicates a higher level of performance, the order is reversed, i.e., MCLEC - MCenturyLink QC .
4.5 For parity submeasurements for which the number of data points is less than or equal to 30, CenturyLink QC will apply a permutation test to determine statistical significance. For such parity submeasurements reported as percentages, where the number of data points is less than or equal to 30, CenturyLink QC will apply an exact proportions test (a form of permutation testing that applies to metrics reported as percentages). The permutation test for...
Statistical Methodology. The primary analysis planned for this study is to evaluate the PK of LOXO-305 after a single dose in subjects with mild, moderate, or severe hepatic impairment, compared to subjects with normal hepatic function. To evaluate the effect of hepatic function group on the PK of a single dose of LOXO-305, paired t-tests will be performed for each hepatic impairment group (by CP classification) versus the normal group with respect to 1-to-1 matching. In addition, an analysis of covariance (ANCOVA) will be performed on the natural log (ln)- transformed AUC0-t, AUC0-inf, and Cmax. The ANCOVA model will contain a categorical factor of population for subjects with varied-degree hepatic impairment (severe, moderate, and mild by CP classification) and healthy matched-control subjects, a categorical covariate (sex), and continuous covariates (age and BMI). Ratios of least squares means and 90% confidence intervals (CIs) will be calculated using the exponentiation of the difference between hepatic function cohort least squares means from the ANCOVA analyses on the ln-transformed AUC0-t, AUC0-inf, and Cmax. In addition, an ANCOVA will be performed on the natural log (ln)-transformed unbound AUC0-t, unbound AUC0-inf, and unbound Cmax. The specific procedures will be documented in the SAP. Similar ANCOVA analysis will be applied for evaluating the effect of hepatic function group by NCI-ODWG classification.
Statistical Methodology. 4.1 For all submeasurements with benchmark standards (“benchmark submeasurements”), as designated in the PIDs, the determination of CenturyLink QC’s conformance with Plan and PID standards will involve comparing performance levels reported for submeasurements against benchmarks established in the PIDs on a “stare-and-compare” basis (i.e., with no additional statistical methodology applied). For all submeasurements with parity standards (“parity submeasurements”), as designated in the PIDs, the determination of CenturyLink QC’s conformance with Plan and PID standards will involve comparing statistical z-scores associated with performance levels reported for submeasurements against statistical critical values as defined in Section 5.0. The calculation of z-scores will be based on a statistical test, called the “modified z-test,” as defined in Section 4.4 below, to determine whether a parity condition exists between the results for CenturyLink QC and for CLEC.
Statistical Methodology. The primary analysis planned for this study is to evaluate the PK of LOXO-305 after a single dose in subjects with renal impairment compared to subjects with normal renal function. Paired t-tests will be performed to assess the differences in PK parameters (AUC0-t, AUC0-inf, and Cmax) between each renal impairment group versus the corresponding matched-control healthy group with respect to 1 to 1 matching. The analysis will be based on the natural log (ln)-transformed PK parameters. Geometric mean ratios and their corresponding 90% confidence intervals (CIs) will be calculated using the exponentiation of the mean difference and the CIs obtained for the difference in mean between each renal impairment group and the matching healthy control group. In addition, an analysis of covariance (ANCOVA) will be performed on the ln-transformed AUC0-t, AUC0-inf, and Cmax. The ANCOVA model will contain a categorical factor of population for subjects with varied-degree renal impairment (severe, moderate, and mild) and matched-control healthy subjects, a categorical covariate (sex), and continuous covariates (age and BMI). Ratios of least squares means and 90% CIs will be calculated using the exponentiation of the difference between renal function cohort least squares means from the ANCOVA analyses on the ln-transformed AUC0-t, AUC0-inf, and Cmax. In addition, an ANCOVA will be performed on the ln-transformed AUC0-t,u, AUC0-inf,u, and Cmax,u. The relationship between LOXO-305 PK parameters (ie, Cmax and AUC) and measures of renal function (such as eGFR and creatinine clearance) may be explored using a linear regression approach or other methods. The effect of covariates such as age, BMI, and sex may be investigated. The specific procedures will be documented in the SAP.