Study Medications Sample Clauses

Study Medications. Alendronate will be sourced locally. Calcium and vitamin D will be provided by the study centers, similar to their provision in Study BA058-05-003.
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Study Medications. All study medications are for investigational use only and are to be used only within the context of this study. The Sponsor will supply all study medications. BA058 80 µg, Placebo and Teriparatide BA058 80 µg, Placebo and teriparatide will be supplied by the Sponsor. Pen devices and needles for administration of study medications also will be supplied to the study sites. BA058 80 µg for Injection: Each multi-dose cartridge contains 2 mg/mL BA058 (free base) in 5 mg/mL tri-hydrate sodium acetate and 5 mg/mL of phenol (preservative) adjusted at pH 5.1 with acetic acid. BA058 80 µg is supplied as a liquid in a 1.5 mL Type 1 glass cartridge and is stored refrigerated at 5 ± 3ºC. The multi-dose cartridge is designed to deliver a dose of 80 µg of BA058 in 40 µL of fluid when inserted into the Pen Injector device. The pen is also capable of delivering a half dose of BA058, or 40 µg of BA058 in 20 µL of fluid, with appropriate manual adjustment. When in use, multi-dose cartridges of BA058 80 µg can be stored for up to 30 days at room temperature. When used with the supplied pen and needles, each cartridge may be used to deliver study medication at the required daily dose for 30 days. Patients will be provided with a sufficient number of cartridges to continue on treatment until the next scheduled return to the study site.

Related to Study Medications

  • Medications Psychotropic medications and medications associated with treating a diagnosed mental health condition.

  • Vaccinations (1) Employees shall be provided with free influenza vaccination once annually.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

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

  • Medication 1. Xxxxxxx’s physician shall prescribe and monitor adequate dosage levels for each Client.

  • Vaccination and Inoculation (a) The Employer agrees to take all reasonable precautions, including in-service seminars, to limit the spread of infectious diseases among employees.

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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