PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS Sample Clauses

PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS. Blood samples for PK analysis of TPOXX will be collected from all subjects Day 1 before study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
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PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS. Single Dose (Part 1):

Related to PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS

  • Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 230 to be assigned to the study: n = 120 to be analysed: n = 120 Duration of intervention per patient of the intervention group: minimum 21 days/3 weeks until patient’s weight >2000g, averaged 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months following enterostomy closure (12- month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 months of overall study duration).

  • 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. 7.7.2 If the Architect determines that any Work requires special inspection, testing, or approval which Subparagraph 7.7.1 does not include, he or she will, upon written authorization from the State, instruct the Contractor to order such special inspection, testing or approval, and the Contractor shall give notice as provided in Subparagraph 7.7.1. If such special inspection or testing reveals a failure of the Work to comply with the requirements of the Contract Documents, the Contractor shall bear all costs thereof, including compensation for the Architect's additional services made necessary by such failure; otherwise the State shall bear such costs, and an appropriate Change Order shall be issued. 7.7.3 Required certificates of inspection, testing or approval shall be secured by the Contractor and promptly delivered by him to the Architect. 7.7.4 If the Architect is to observe inspections, tests or approvals required by the Contract Documents, he will do so promptly.

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