Description of Study Drug Sample Clauses

Description of Study Drug. Bardoxolone methyl (RTA 402) drug product information is shown in Table 5. Information about the placebo is shown in Table 6. Description Bardoxolone methyl capsule (5 mg, 15 mg) Ingredients Bardoxolone methyl Methacrylic Acid – Ethyl Acrylate Copolymer Type A Silicified Microcrystalline Cellulose Hydroxypropyl Methylcellulose Lactose Monohydrate Sodium Lauryl Sulfate Colloidal Silicon Dioxide Magnesium Stearate Gelatin capsules Titanium Dioxide Route of Administration Oral Description Placebo for bardoxolone methyl capsule (size #4 and size #1) Ingredients Silicified Microcrystalline Cellulose Lactose monohydrate Magnesium Stearate Gelatin capsules Titanium Dioxide Route of Administration Oral
Sample 1
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Description of Study Drug. Bardoxolone methyl (RTA 402) drug product information is shown in Table 4. Information about the placebo is shown in Table 5. Table 4: Bardoxolone Methyl Drug Product Information Bardoxolone methyl capsule (2.5 mg, 5 mg) Description Oral Route of Administration Table 5: Placebo Information Description Placebo for bardoxolone methyl capsule (2.5 mg, 5 mg) Ingredients Silicified Microcrystalline Cellulose Lactose monohydrate Magnesium Stearate Gelatin capsules Titanium Dioxide (capsule pigment) Route of Administration Oral
Sample 1
Description of Study Drug. LJPC-501 drug product is a sterile, aqueous solution for dilution prior to infusion that is supplied in single-dose vials (Table 5). Vials contain 2.5 mg/mL angiotensin II and 25 mg/mL mannitol as an excipient in water for injection. LJPC-501 is diluted in normal saline for continuous IV infusion administration. The infusion rate of LJPC-501 may be adjusted to maintain adequate MAP. Table 5: Investigational Product Investigational Product Product Name: LJPC-501 (angiotensin II) Dosage Form: Injection Unit Dose: 2.5 mg/mL Route of Administration: IV infusion Physical Description: aqueous solution Manufacturer: Emergent BioSolutions, Inc. (EBSI)
Sample 1
Description of Study Drug. RBM-007 is a pegylated oligonucleotide-based aptamer. RBM-007 injectable solution is a formulation designed for intravitreal injection.
Sample 1
Description of Study Drug. The investigational products for this cohort are described in Table 7. Table 7: Investigational Product Investigational Product Product name: TSR-042 Bevacizumab (Avastin) Niraparib Dosage form: Solution for infusion Infusion Capsule Unit dose 500 mg, 50 mg/mL 15 mg/kg infusion 100 mg per capsule Route of administration Intravenous Intravenous Oral Physical description Solution for intravenous infusion in single-use vial Clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion Capsules in high-density polyethylene bottles Manufacturer WuXi AppTec Genentech, Inc. QSP (Xxxxxxx River Laboratories Contract Manufacturing)
Sample 1

Related to Description of Study Drug

  • 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.

  • How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. How to File an Expedited Appeal Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.

  • Clinical 1.1. Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • 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.

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

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Protocol The attached Protocol shall be an integral part of this Agreement.

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