Pharmacoeconomic Studies definition

Pharmacoeconomic Studies means clinical studies designed with the primary intention of developing pharmacoeconomic data.
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Examples of Pharmacoeconomic Studies in a sentence

  • Summary Quality Scores for Pharmacoeconomic Studies: Balancing Validity with Need.

  • Investigating the Evidence.” Center for Pharmacoeconomic Studies: The University of Texas at Austin.

  • We also acknowledge Michael Smith, M.S., R.Ph., Research Assistant for the Center for Pharmacoeconomic Studies, for assistance in data analyses, and Curtis Burch, R.Ph., Program Director, Texas Medicaid Vendor Drug Program, Texas Department of Health, for data coordination support.

  • Johnson School of Public Affairs Michael Johnsrud, Ph.D., R.Ph.The Center for Pharmacoeconomic Studies, The University of Texas at Austin ▪ Literature Review and Analysis on Cancer Prevention and Cost-EffectivenessLauren Rivera Jahnke, M.P.Aff.

  • Desai PR, Chandwani HS, Rascati KL: Assessing the Quality of Pharmacoeconomic Studies in India.

  • This perspective was substantially set for NICE in the two years prior to its establishment (1997–1998) in a Department of Health Expert Workshop on DH Guidelines for Pharmacoeconomic Studies, comprised of officials and academic health economists, chaired by me.This represents a significant departure from the ‘societal perspective’ com- monly advocated in the cost-effectiveness literature (e.g. Gold et al., 1996).

  • Claims made as a result of a pharmacoeconomic study or model should be consistent with the PAAB’s Guidance Document for the Use of Pharmacoeconomic Studies in Advertising.and designed to promote credibility and trust.

  • Table 4: Results of CATIE and CNOMSS Pharmacoeconomic Studies in 2005 C$*Type of CostAE=adverse event; AAP=atypical antipsychotic; CATIE=clinical-effectiveness trials of intervention effectiveness; CNOMSS=Canadian National Outcomes Measurements Study in Schizophrenia; d=day; EPS=extra-pyramidal symptoms; mg=milligram; NA=not available.

  • Prior to joining Avalere, Michael spent over a decade conducting research at The Center for Pharmacoeconomic Studies at the University of Texas at Austin, College of Pharmacy, where he currently serves on the Dean’s Advisory Council.

  • National Pharmaceutical Pricing Authority (NPPA) – National Pharma Pricing Policy:  Prioritization and Identification of drugs/products in India, which are pharmaco-economically more important and beneficial. Creation of database by sponsoring/conduction PE studies- Pharmacoeconomic Studies and Health Technology Evaluation.

Related to Pharmacoeconomic Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Research means a methodical investigation into a subject.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.