Study Drug Preparation Sample Clauses

Study Drug Preparation. The Pharmacy Manual contains specific instructions for the preparation of each dose of the niraparib capsules and TSR-042 infusion solutions. Refer to local prescribing information for instructions for the preparation of bevacizumab.
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Study Drug Preparation. A pharmacist or designee will remove the appropriate number of vials of LJPC-501 from the refrigerator and prepare the LJPC-501 under aseptic conditions. The amount of LJPC-501 to be administered will be determined based on the Screening body weight (measurement method by local SOC). Contents of single-dose vials of LJPC-501 will be added to normal saline (0.9% sodium chloride solution). Polyvinyl chloride (PVC) or non-PVC bags are acceptable. The solution should be clear and colorless with no visible particles. Please refer to the Pharmacy Manual for detailed instructions. Discard prepared diluted solution of LJPC-501 after 24 hours at room temperature or under refrigeration.
Study Drug Preparation. Once an investigational drug vial number has been assigned to the subject, the vial of investigational drug with the assigned vial number will be removed from the freezer. The contents should be thawed by rotating the vials between the palms of the hands, or by setting the vial at room temperature. Care should be taken to protect the product from light. Investigational drug should be used for intravitreal injection in the study subject within 1 hour after removing the vial from the freezer. Each vial contains enough RBM-007 to inject one subject. Each vial will be used one time only.
Study Drug Preparation. ‌ Activated applicators are stable for 4 hours at room temperature (59ºF to 77ºF or 15ºC to 25ºC).

Related to Study Drug Preparation

  • Joint Preparation The preparation of this Agreement has been a joint effort of the parties and the resulting documents shall not, solely as a matter of judicial construction, be construed more severely against one of the parties than the other.

  • 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.

  • Surface Preparation Clean the surface to be treated of all dust, dirt, clay, grass, sod and any other deleterious matter before application of the asphalt surface treatment.

  • Site Preparation Contractor shall not begin a project for which the site has not been prepared, unless Contractor does the preparation work at no cost, or until Region 4 ESC includes the cost of site preparation in a purchase order. Site preparation includes, but is not limited to: moving furniture, installing wiring for networks or power, and similar pre-installation requirements.

  • Proposal Preparation The contractor shall assume all costs associated with preparation of proposals for task order awards under the proposal process as an indirect charge (B&P costs). The Government will not reimburse awardees for proposals as a direct charge.

  • 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.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Planning and Preparation 1. Uses established local and the Core Curriculum Standards and Cumulative Progress Indicators as well as established local and state curriculum objectives in planning lessons.

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • Prescription Drug Program 1. It is agreed that the State shall continue the Prescription Drug Benefit Program during the period of this Agreement. The program shall be funded and administered by the State. It shall provide benefits to all eligible unit employees and their eligible dependents. Each prescription required by competent medical authority for Federal legend drugs shall be paid for by the State from funds provided for the Program subject to a deductible provision which shall not exceed $5.00 per prescription or renewal of such prescription and further subject to specific procedural and administrative rules and regulations which are part of the Program.

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