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.
Sample 1

Related to Dose Selection Rationale

  • Shift Selection Employee assignments within the Patrol Bureau will occur between approximately April 1-15 and shall be awarded based upon seniority. Approximately three (3) months before then the Department will publish a call for written requests on shift assignment. Employees will make their first three (3) choices known. Employees will learn of the assignment, including days off associated with their assignment, immediately after the bidding process is completed. Assignments will take effect on the schedule immediately following July 1st. Residence Hall assignments will be made prior to all others. No officer will be required to work a Residence Hall assignment in consecutive years. Assignment of the remaining officers will begin with selection(s) for day and night shifts. The bid for assignments will continue until all positions are filled. The following general rules apply to assignments: 1. During the term of this Agreement, no employee will be reassigned to a different shift other than the shift awarded by seniority except in situations where the University cannot continue to provide police services. In the event a shift reassignment must occur, it will be offered to volunteers based on seniority. If there are no volunteers it will be assigned to the least senior officer in the department. 2. Shift selection shall be an appropriate subject for the Joint Labor/Management Committee. 3. If a shift becomes available as a result of trainees being released for duty, and if there is at least four (4) months until the next shift change, the shift will be posted and awarded by seniority. The new trainee released for duty will take the senior officers shift. If no employee desires the shift, the trainee scheduled for assignment will be assigned that shift. The parties recognize that for the betterment of the Department it may be necessary to assign a trainee to a specific shift. 4. Voluntary shift trades will be allowed as long as overtime costs are not incurred. 5. Except in a bona fide emergency, no employee shall be assigned to work more than sixteen (16) hours in a twenty-four (24) hour period, provided however employees may volunteer to work up to eighteen (18) hours in a twenty-four (24) hour period.

  • 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 2. If a Panelist appointed under this Article resigns or becomes unable to act, a successor Panelist shall be appointed within 30 days in accordance with the selection procedure as prescribed for the appointment of the original Panelist and the successor shall have all the powers and duties of the original Panelist. The work of the Panel shall be suspended during the appointment of the successor Panelist.

  • Site Selection 5.1.1 If the parties have not designated the street address of the Franchised Location on Exhibit A on the Effective Date, Franchisee shall identify, submit and obtain Franchisor’s prior written approval of the Franchised Location meeting the requirements of this Agreement prior to entering a lease or sublease for the Franchised Location. Franchisee shall provide Franchisor all information required by Franchisor, as determined by Franchisor in Franchisor’s sole determination, necessary for Franchisor to evaluate the Franchised Location. Franchisor shall have ten (10) business days to review Franchisee’s written site proposal for the Franchised Location and notify Franchisee of its approval or disapproval in writing. Franchisor’s failure to respond within ten (10) business days shall signify Franchisor’s disapproval of the site. Franchisor shall not unreasonably withhold Franchisor’s approval of a proposed site for the Franchised Location. 5.1.2 Franchisee must have a site for the Franchised Location approved by Franchisor, receive the opening notice from Franchisor described in Section 5.4 below, and open Franchisee’s Franchised Business for business within six (6) months from the Effective Date, except as otherwise provided in Section 5.1.3 All matters related in any way to Franchisee’s site are Franchisee’s sole responsibility, regardless of any assistance Franchisor may choose to provide. Franchisee is responsible for obtaining any architectural and engineering services required for Franchisee’s facility and for ensuring its compliance with local law. Neither Franchisor, nor any other person or company associated with Franchisor shall have any liability for any site‐related matter. Xxxxxxxxxx agrees not to make any claims against Franchisor and/or any of Franchisor’s affiliates or associates with regard to such matters. 5.1.4 If Franchisor makes a loan to Franchisee for (i) Franchisee’s purchase of the franchise for the Franchised Business; (ii) the remodeling of the Franchised Location; (iii) the transfer of any interest in this franchise or this Agreement; or (iv) any other purpose; Franchisee shall open (or re‐open, as the case may be), the Franchised Business for business within sixty (60) days from the loan origination date.

  • Adverse Selection No selection procedures adverse to the Noteholders were utilized in selecting the Receivables from those receivables owned by the Seller which met the selection criteria set forth in this Agreement.

  • Distribution Compliance Period The Purchaser agrees not to resell, pledge or transfer any Purchased Shares within the United States or to any U.S. Person, as each of those terms is defined in Regulation S, during the 40 days following the Closing Date.

  • Desirable Selection Criteria Post registration qualification in the area of specialty or evidence of significant progression towards one.

  • 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.

  • 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.