Pharmacokinetic Analyses Sample Clauses

Pharmacokinetic Analyses. PK parameters will not be calculated due to the sparse sampling scheme in this study. Summary statistics of the concentration at each time point (nominal time) will be presented. Graphical presentation of the data may also be completed using nominal time.
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Pharmacokinetic Analyses. Individual plasma concentration and time deviation data will be presented in a data listing. Plasma concentration data will be listed and summarized using the following descriptive statistics: number of subjects, arithmetic mean, standard deviation (SD), coefficient of variation (CV), geometric mean, geometric CV, median, minimum, and maximum. Individual and mean plasma concentration versus time profiles will be presented in figures on both linear and semilogarithmic scales. The PK parameters of TPOXX will be analyzed based on the actual sampling times. All parameters will be determined using noncompartmental methods using Phoenix® WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 or higher (SAS Institute Inc., Cary, North Carolina). The individual PK parameters and weight-normalized PK parameters will be presented in data listings and summarized using the following descriptive statistics: number of subjects, arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and geometric CV.
Pharmacokinetic Analyses. Plasma concentrations will be listed and summarized descriptively (number of subjects, arithmetic mean, SD, coefficient of variation (CV), geometric mean, geometric CV, median, minimum, and maximum). Plasma concentration versus time profiles for each subject will be presented graphically. The mean plasma concentration versus scheduled time profiles will be presented graphically. Pharmacokinetic parameters derived from plasma samples using noncompartmental methods with Phoenix® WinNonlin® (Certara USA Inc., Princeton, New Jersey) Version 8.0 or higher or SAS Version 9.3 or higher (SAS Institute Inc., Cary, North Carolina) will be summarized by treatment and ethnicity using descriptive statistics (number of subjects, mean, SD, CV, geometric mean, geometric mean CV, median, minimum, and maximum). The parameter Tmax will be summarized by treatment using the number of subjects, median, minimum, and maximum values.

Related to Pharmacokinetic Analyses

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Data Analysis In the meeting, the analysis that has led the College President to conclude that a reduction- in-force in the FSA at that College may be necessary will be shared. The analysis will include but is not limited to the following: ● Relationship of the FSA to the mission, vision, values, and strategic plan of the College and district ● External requirement for the services provided by the FSA such as accreditation or intergovernmental agreements ● Annual instructional load (as applicable) ● Percentage of annual instructional load taught by Residential Faculty (as applicable) ● Fall 45th-day FTSE inclusive of dual enrollment ● Number of Residential Faculty teaching/working in the FSA ● Number of Residential Faculty whose primary FSA is the FSA being analyzed ● Revenue trends over five years for the FSA including but not limited to tuition and fees ● Expenditure trends over five years for the FSA including but not limited to personnel and capital ● Account balances for any fees accounts within the FSA ● Cost/benefit analysis of reducing all non-Residential Faculty plus one Residential Faculty within the FSA ● An explanation of the problem that reducing the number of faculty in the FSA would solve ● The list of potential Residential Faculty that are at risk of layoff as determined by the Vice Chancellor of Human Resources ● Other relevant information, as requested

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Statistical Analysis 31 F-tests and t-tests will be used to analyze OV and Quality Acceptance data. The F-test is a 32 comparison of variances to determine if the OV and Quality Acceptance population variances 33 are equal. The t-test is a comparison of means to determine if the OV and Quality Acceptance 34 population means are equal. In addition to these two types of analyses, independent verification 35 and observation verification will also be used to validate the Quality Acceptance test results.

  • Trials The Ship shall run the following test and trials:

  • Tests 7.7.1 If the Contract Documents, laws, ordinances, rules, regulations or orders of any public authority having jurisdiction require any portion of the Work to be inspected, tested or approved, the Contractor shall give the Architect timely notice of its readiness so the Architect may observe such inspection, testing or approval. The Contractor shall bear all costs of such inspections, tests or approvals conducted by public authorities.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

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