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 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.
Study Medications. The Step 1 initial treatment regimens in A5208/OCTANE will consist of TDF and FTC, combined with either LPV/RTV or NVP. The TDF/FTC backbone was chosen for several reasons: 1) Combinations of TDF, FTC, and an NNRTI or PI are extremely potent and have been associated with substantial virologic response rates in several studies in treatment-naïve patient populations. 2) TDF and FTC can be taken QD, which is likely to enhance adherence. 3) TDF should be well-tolerated; it is less likely to be associated with anemia than ZDV-based regimens and less likely to be associated with facial wasting and/or lipid metabolism dysregulation than d4T-based regimens. Although ZDV- and d4T-based regimens are currently more widely available in settings in which this study will be undertaken, it is anticipated that TDF will be readily available in the near future and experience with it in settings where ZDV- and d4T-associated resistance mutations are being selected will be critical. Gilead announced in April 2003 the Gilead Access Program, which will provide access to TDF at no profit in every country in Africa and in 15 additional countries in other parts of the world classified as "least developed" by the United Nations (UN). It will be important to gain clinical experience with TDF as this drug becomes more available in the developing world. WHO guidelines acknowledge that PIs are an accepted standard of care as part of first-line ART regimens, and that “advantages of PI-based regimens …are proven clinical efficacy and well described toxicities” [WHO, 2003]. Disadvantages include cost, heat instability (with certain PIs), and drug interactions with medications such as rifampin, which is used in tuberculosis (TB) treatment regimens. If, however, a PI-based regimen is shown to be of significantly superior efficacy than an NNRTI-based regimen, particularly among women who previously took SD NVP, then PIs may replace NNRTIs in first-line regimens for at least a subset of persons requiring ART in developing nations. Since late 2002, as significant strides have been made in price reductions for several PIs, these agents are becoming more readily available. LPV/RTV has recently been chosen by the government national ART programs of both Botswana and South Africa to become the PI of choice on their formularies. With increasing documentation of NNRTI resistance in the HIV-infected population in the United States [Little, 2002], which is likely to follow elsewhere with increasing us...

Related to Study Medications

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

  • Vaccinations Contractor understands, acknowledges, and agrees that, pursuant to Article II of the General Appropriations Act, none of the General Revenue Funds appropriated to the Department of State Health Services (DSHS) may be used for the purpose of promoting or advertising COVID-19 vaccinations in the 2024-25 biennium. It is also the intent of the legislature that to the extent allowed by federal law, any federal funds allocated to DSHS shall be expended for activities other than promoting or advertising COVID-19 vaccinations. Contractor represents and warrants that it is not ineligible, nor will it be ineligible during the term of this Contract, to receive appropriated funding pursuant to Article II.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Medication 1. Xxxxxxx’s physician shall prescribe and monitor adequate dosage levels for each Client. 2. Xxxxxxx’s physician shall not impose and/or limit dosage capitations for any prescribed medication for the treatment of opioid use disorder.

  • Vaccination and Inoculation ‌ (a) The Employer agrees to take all reasonable precautions to limit the spread of infectious diseases among employees, including in-service seminars for employees. Where the Employer or Occupational Health and Safety Committee identifies high risk areas which expose employees to infectious or communicable diseases for which there are protective immunizations available, such immunizations shall be provided at no cost to the employee. The Committee may consult with the Medical Health Officer. Where the Medical Health Officer identifies such a risk, the immunization shall also be provided at no cost. The Employer shall provide Hepatitis B vaccine, free of charge, to those employees who may be exposed to bodily fluids or other sources of infection. (b) An employee may be required by the Employer, at the request of and at the expense of the Employer, to take a medical examination by a physician of the employee's choice. Employees may be required to take skin tests, x-ray examination, vaccination, and other immunization (with the exception of a rubella vaccination when the employee is of the opinion that a pregnancy is possible), unless the employee's physician has advised in writing that such a procedure may have an adverse effect on the employee's health.

  • 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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