Dose Selection Rationale Sample Clauses

Dose Selection Rationale. The dose of eteplirsen used in this study is 30 mg/kg. This dose was chosen based on results from the Phase 2, double-blind, placebo-controlled, multiple-dose study, Study 4658-us-201, and its open-label extension, Study 4658-us-202. As described in Section 5.3, these studies assessed the efficacy, safety, tolerability, and PK of 2 eteplirsen doses (50 and 30 mg/kg) administered as IV infusions in twelve 7- to 13-year-old pediatric patients diagnosed with DMD with out of frame mutations amenable to treatment by skipping exon 51. Once weekly treatment with 30 mg/kg eteplirsen for 24 weeks significantly increased the mean percentage of dystrophin-positive muscle fibers as percent (%) of normal in DMD patients compared to placebo. At Week 48, increases in the percent of dystrophin-positive fibers were similar for patients who had received weekly 30 and 50 mg/kg eteplirsen without interruption from Week 1 (52% and 42% of normal, respectively or 47% for the combined groups). These data suggest that the effect of eteplirsen on the production of novel dystrophin is not significantly different between the two doses tested in this study. Therefore, the lower dose was selected as the more conservative choice, because patients presumably would receive this drug as a life-long treatment.
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Related to Dose Selection Rationale

  • Shift Selection In multiple shift operations, employees within each classification shall have a right to select their work shift on the basis of their seniority within a bureau or division thereof and competing only with employees covered under this agreement on the following basis:

  • Single Source Selection Services for tasks in circumstances which meet the requirements of paragraph 3.10 of the Consultant Guidelines for Single Source Selection, may, with the Association's prior agreement, be procured in accordance with the provisions of paragraphs 3.9 through 3.13 of the Consultant Guidelines.

  • Panel Selection 1. The Parties shall apply the following procedures in selecting a Panel: (a) the Panel shall comprise 3 members; (b) within 15 days following the date of the establishment of the Panel, each Party shall nominate a Panelist; (c) the Parties shall endeavor

  • Quality-based Selection Services for assignments which the Bank agrees meet the requirements set forth in paragraph 3.2 of the Consultant Guidelines may be procured under contracts awarded on the basis of Quality-based Selection in accordance with the provisions of paragraphs 3.1 through 3.4 of the Consultant Guidelines.

  • Desirable Selection Criteria 1. Possession of, or significant progression toward the attainment of a post graduate qualification in area of specialty.

  • Least-cost Selection Services for assignments which the Association agrees meet the requirements of paragraph 3.6 of the Consultant Guidelines may be procured under contracts awarded on the basis of Least-cost Selection in accordance with the provisions of paragraphs 3.1 and 3.6 of the Consultant Guidelines.

  • EPP transform-command RTT Refers to the RTT of the sequence of packets that includes the sending of a transform command plus the reception of the EPP response for only one EPP transform command. It does not include packets needed for the start or close of either the EPP or the TCP session. EPP transform commands are those described in section 2.9.3 of EPP RFC 5730. If the RTT is 5 times or more the corresponding SLR, the RTT will be considered undefined.

  • Measuring EPP parameters Every 5 minutes, EPP probes will select one “IP address” of the EPP servers of the TLD being monitored and make an “EPP test”; every time they should alternate between the 3 different types of commands and between the commands inside each category. If an “EPP test” result is undefined/unanswered, the EPP service will be considered as unavailable from that probe until it is time to make a new test.

  • Measuring DNS parameters Every minute, every DNS probe will make an UDP or TCP “DNS test” to each of the public-­‐DNS registered “IP addresses” of the name servers of the domain name being monitored. If a “DNS test” result is undefined/unanswered, the tested IP will be considered unavailable from that probe until it is time to make a new test.

  • Selection Criteria Each Contract is secured by a new or used Motorcycle. No Contract has a Contract Rate less than 1.00%. Each Contract amortizes the amount financed over an original term no greater than 84 months (excluding periods of deferral of first payment). Each Contract has a Principal Balance of at least $500.00 as of the Cutoff Date.

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