Pharmacokinetic Analysis Clause Samples
Pharmacokinetic Analysis. Whenever possible, the following PK parameters will be calculated for each subject, based on the plasma concentrations of LOXO-305: Cmax maximum observed plasma concentration tmax time to maximum observed plasma concentration AUC0-t AUC from hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing and decreasing concentrations AUC0-inf AUC from hour 0 extrapolated to infinity, calculated using the formula: Ct AUC0-inf = AUC0-t + λz where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant %AUCextrap percentage extrapolation for AUC0-inf λZ apparent terminal elimination rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus-time profile during the terminal phase t1/2 apparent plasma terminal elimination half-life (whenever possible), where t1/2 = natural log (2)/λZ CL/F apparent systemic clearance Vz/F apparent volume of distribution during the terminal phase MRT mean residence time fu unbound fraction, calculated as unbound concentration divided by total concentration The fu value determined for each subject will be used to calculate the following unbound LOXO-305 PK parameters for each individual subject: Cmax,u Unbound Cmax, calculated as Cmax*fu AUC0-t,u Unbound AUC0-t, calculated as AUC0-t*fu AUC0-inf,u Unbound AUC0-inf, calculated as AUC0-inf*fu CL/F,u Unbound CL/F, calculated as Dose/AUC0-inf,u Vz/F,u Unbound Vz/F, calculated as CL/F,u/λZ Pharmacokinetic calculations will be performed using commercial software such as Phoenix™ WinNonlin® Version 8.1 or higher (Certara USA Inc.). Other parameters may be added as appropriate. Final PK parameters reported will be detailed in the Statistical Analysis Plan (SAP). Pharmacokinetic analysis will use actual times as recorded on the eCRF. All statistical analyses will be performed using SAS® Version 9.4 or greater. More details on the analyses will be included in the SAP.
Pharmacokinetic Analysis. (a) The Parties hereby agree that Novartis shall, at no cost to QED, conduct certain pharmacokinetic analyses and related activities for the clinical study entitled: [***] pursuant to the Statement of Work attached hereto as Schedule 1. The Parties hereby agree that all results of all such activities performed by Novartis pursuant to this Statement of Work, including all reports, records, results, data and other information generated in the conduct of such activities, shall be considered “Novartis Know-How,” notwithstanding anything to the contrary in the definition of “Novartis Know-How” and licensed to QED pursuant to Section 2.1 of the License Agreement. Novartis will conduct such activities in accordance with all Applicable Laws and all applicable industry standards and practices. QED acknowledges that reports, records, results, data and other information generated in the conduct of such activities shall be provided “as is” and without implied warranties of merchantability or fitness for a particular purpose, and any use made by QED of such reports, records, results, data and other information is at its own risk.
Pharmacokinetic Analysis. Pharmacokinetic analysis will be done using a validated computer program. The PK characteristics of ALXN2050 from patients, including, but not limited to, the standard PK parameters outlined in the table below, will be derived from the individual plasma concentration time data on study day(s) with intensive PK sampling. Descriptive statistics (number of patients, mean/geometric mean, SD, median, minimum, and maximum) will be used to summarize the calculated PK parameters. AUC0-12 Area under the curve Cmax Maximum plasma concentration tmax Time after administration of a drug when the maximum plasma concentration is reached C(0) Trough concentration at start of steady-state dose interval C(12) Trough concentration at end of steady-state dose interval