Selection of Dose Sample Clauses

Selection of Dose. The dose of alendronate (70 mg per week, oral) selected for this study is based upon the recommended daily dose in the product’s prescribing information. All enrolled subjects will also continue to receive calcium (500-1000 mg) and vitamin D (400-800 IU) supplementation.
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Selection of Dose. The BA058 dose to be studied in this Phase 3 trial has been previously studied in the Phase 1 and Phase 2 clinical trials. The dose chosen for this study is based on the safety and pharmacodynamic information derived in study BA058-05-002 according Attachment 2, Attachment E-20 to predetermined criteria provided in the protocol. The 80 µg dose was the maximum efficacy dose in the BA058 Phase 2 clinical program, was well tolerated (refer to Section 0) and demonstrated a significant increase in mean lumbar spine and mean femoral neck BMD when compared to Placebo. This beneficial effect was achieved safely and with substantially less hypercalcemia than teriparatide. Doses of up to 120 µg have been studied in the Phase 1 program and 100 µg has been determined to be the maximum tolerated dose, due to patients experiencing an increase in nausea and one discontinuation due to vomiting at the 120 µg dose. BA058 80 µg per day will be dosed by SC self-administered injection. In addition, a matching Placebo comparator will be employed in one treatment arm and teriparatide will be employed as a reference drug and comparator for secondary efficacy and safety outcomes. All enrolled patients will also receive Calcium (500-1000 mg) and Vitamin D (400-800 IU) supplementation, or a dose to be determined by the Investigator and agreed by the Sponsor Medical Monitor, according to the patient’s need, from the Pretreatment Period until the end of the Treatment Period; it will be recommended to patients that they continue these supplements through the Follow-up Period. The treatment regimens are summarized in the table in Section 0. Attachment 2, Attachment E-21 STUDY OBJECTIVES The primary objective of this study is to determine the safety and efficacy of BA058 80 µg when compared to Placebo for prevention of vertebral fracture in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis. The secondary objectives of this study are to determine the safety and efficacy of BA058 80 µg when compared to Placebo for prevention of non-vertebral fractures and for additional secondary efficacy outcomes (bone mineral density of spine, hip and femoral neck) and safety (hypercalcemia) when compared to teriparatide (Xxx Xxxxx and Co.) in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis. The specific objectives of this study are to: · Determine the comparative efficacy of 18 months of treatment with BA058 80 µ...
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Related to Selection of Dose

  • ELECTION OF DOMICILE The parties agree to elect domicile in the judicial district of Beijing, China, and chose it as the appropriate district to hear any claim arising from the interpretation, application, performance, the entry into force, validity and effect of this contract.

  • Certification of Documents The required copy of the Agreement and Declaration of Trust of Fund and copies of all amendments thereto will be certified by the appropriate official of The Commonwealth of Massachusetts; and if such Agreement and Declaration of Trust and amendments are required by law to be also filed with a county, city or other officer or official body, a certificate of such filing will appear on the certified copy submitted to Service Company. A copy of the order or consent of each governmental or regulatory authority required by law for the issuance of Fund shares will be certified by the Secretary or Clerk of such governmental or regulatory authority, under proper seal of such authority. The copy of the Bylaws and copies of all amendments thereto and copies of resolutions of the Board of Trustees of Fund will be certified by the Secretary or an Assistant Secretary of Fund.

  • Selection of Mediator The complaining party shall submit a Request for Mediation to the AAA. The AAA will appoint a qualified mediator to serve on the case. The preferred mediator shall have specialized knowledge of securities law, unless the Dispute pertains to financial accounting issues, in which case the arbitrator shall be a CPA, or if no such person is available, shall be generally familiar with the subject matter involved in the Dispute. If the parties are unable to agree on the mediator within thirty (30) days of the Request for Mediation, the AAA case manager will make an appointment. If the initial mediation(s) does not completely resolve the Dispute, any party may request a different mediator for subsequent mediation(s) by serving notice of the request to the other party(ies) for approval, and subject to qualification per the requirements stated above.

  • Selection Procedures In selecting the Loan Assets to be Pledged pursuant to this Agreement, no selection procedures were employed which are intended to be adverse to the interests of the Lenders.

  • Selection Process The Mortgage Loans were selected from among the outstanding one- to four-family mortgage loans in the Seller's portfolio at the related Closing Date as to which the representations and warranties set forth in Subsection 9.02 could be made and such selection was not made in a manner so as to affect adversely the interests of the Purchaser;

  • Retention of Documents The Registrar shall retain copies of all letters, notices and other written communications received pursuant to this Article II. The Company shall have the right to inspect and make copies of all such letters, notices or other written communications at any reasonable time upon the giving of reasonable written notice to the Registrar.

  • Protection of Documents All documents, records and files, in any media of whatever kind and description, relating to the business, present or otherwise, of the Company or any of its Affiliates, and any copies, in whole or in part, thereof (the “Documents”), whether or not prepared by you shall be the sole and exclusive property of the Company. You agree to safeguard all Documents and to surrender to the Company, at the time your employment terminates or at such earlier time or times as the Committee or its designee may specify, all Documents then in your possession or control.

  • Selection of Underwriter In the case of any registration effected pursuant to this Agreement, the Company shall have the right to designate the managing underwriter in any underwritten offering, subject to the approval of the holders of a majority of the Registrable Shares requested to be included in such offering, which approval shall not be unreasonably withheld.

  • Determination of LIBOR ARTICLE V

  • Administrative Procedures Administrative procedures with respect to the sale of Notes shall be agreed upon from time to time by the Agents and the Company (the "Procedures"). The Agents and the Company agree to perform the respective duties and obligations specifically provided to be performed by them in the Procedures.

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