Pharmacokinetic (PK) Analyses Sample Clauses

Pharmacokinetic (PK) Analyses. The PK parameters of OPT-302 will be estimated using standard non-compartmental methods and summarized by cohort and dose level using means, standard deviations, medians, minimum and maximums. Individual serum / time profiles will be summarized by dose level. OPT-302 concentrations at each time point along with PK parameter values may be listed for each subject. Summary statistics will be computed for each sampling time and parameter as appropriate. Additional analyses of OPT-302 concentration-time data using compartmental methods may be performed.
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Related to Pharmacokinetic (PK) Analyses

  • 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.

  • 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.

  • 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 Full-Time Student Equivalent (FFTE) 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

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

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • 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.

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

  • Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.

  • Screening 3.13.1 Refuse containers located outside the building shall be fully screened from adjacent properties and from streets by means of opaque fencing or masonry walls with suitable landscaping.

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