Statistical study definition

Statistical study means any project consisting of or based on assembling, classifying, and/or tabulating numerical data to present significant information about a given subject.
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Statistical study. The results section is assumed to be based on the 209 tables specified in Appendices 1 and 2 (153 tables identical to Action II ISS tables, and 77 additional tables). It is assumed that methods and results sections covering plasma pimagedine data and Quality of Life will be written by their corresponding vendors or will be written by, (including relationship of plasma pimagedine to efficacy or safety) Alteon. It is assumed that these sections will be supplied to Quintiles as drop-in sections and that these will use section numbering as specified by Quintiles. Further, it is assumed that text covering results for Quality of life and plasma pimagedine data for the ISE (and for the ISS if appropriate) will be supplied as a drop-in section. Quintiles has assumed that an integrated set of comments is received from Alteon within * days of shipment of each batch of ISS or ISE tables. Further, Quintiles has assumed that draft tables will be revised to produce final tables as indicated by the integrated comments from Alteon, within at most * weeks of receipt of comments, except for the last batch of ISE tables where revised tables will be shipped within * of receiving comments. This timeline assumes that as a result of Alteon's comments on each batch of ISS or ISE tables, no new tables are required, no additions to tables are required, no changes are made to any definitions, and no additional exploratory analyses are needed. Quintiles has assumed that Alteon is able to obtain FDA agreement to the ISS ARO, the ISE ARO, and the data analysis rules for the ISS and ISE by *. Quintiles also assumes that no additional analyses are required as a result of the Pre-NDA meeting scheduled for *. If such additional analyses are required then these will be billed on a fee-for-service basis and this is likely to impact on the NDA timeline. Quintiles has assumed that all data on patients who are lost to follow-up (including any additional data collected as a result of active searching for these lost to follow-up patients) is received at Quintiles by * for Action I patients and by * for Action II patients. Quintiles has assumed that the last DCF for any data retrieved for lost to follow-up patients is resolved by * for Action I patients and by * for Action II patients. Any delays in receipt of this information may lead to delays in all subsequent dates on the timeline. This budget estimate does not include costs for Quintiles to scan CRFs. Any support provided by Quintiles in conn...
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Statistical study means any project consisting of or based on assembling, classifying, and/or tabulating numeri- cal data to present significant information about a given sub- ject.
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Examples of Statistical study in a sentence

  • Statistical study of typical examples and bubble bursting robustness‌ γWe consider the three cases highlighted in figure 1: Bo = 0.01 and La = 2000, 10000, 100000, and for each case we run, respectively, 118, 115 and 119 simulations with a different random noise in the initial conditions.

  • Statistical study of clathrate–hydrate nucleation in a water/hydrochlorofluorocarbon system: search for the nature of the ‘‘memory effect’’.

  • Statistical study for sonographic differential diagnosis of tumorous lesions in the parotid gland.

  • Statistical study of the soft X-ray events is the primary focus of this study.

  • Pros and cons: Due to the limited number of services listed on the FACTS system, case records would be the only source of service information on a majority of support services including parent education, respite services and mental health care.

  • Statistical study of variation in systemic and articular indexes.

  • Statistical study of the incidence of agenesis in a sample of 1529 subjects].

  • Knopoff, Statistical study of the oc- currence of shallow earthquakes, Geophys.

  • Statistical study of the relation job and disorders shows no correlation.QUALITY IMPROVEMENT IN SECURE FORENSIC SETTINGSS Holder, S Tucker, G MurphyRoyal College of Psychiatrists, London, UK Objectives (119): The Quality Network for Forensic Mental Health Services (QNFMHS) aims to facilitate quality improvement and change in forensic mental health settings through a supportive network and peer-review process.The network adopts a multi-disciplinary approach to quality improvement.

  • Statistical study of the influence of talker’s gender on the results of objective algorithms is also an interesting topic.

Related to Statistical study

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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 III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

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

  • 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 Trial means any human clinical trial of a Product.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Endpoint means any Federal Reserve Bank, financial institution, local clearing house, courier or other entity or location for the delivery of cash letters or other presentment of Imaged Items or Substitute Checks.

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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;

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Research Results means any technical result acquired based on the Collaborative Research, including, but not limited to, any invention, idea, design, copyrightable work and know-how which relates to the purpose of the Collaborative Research.

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

  • Unproven/ Experimental treatment means the treatment including drug experimental therapy which is not based on established medical practice in India.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • 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 III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • hit means the existence of a match or matches established by the Central System by comparison between biometric […] data recorded in the computerised central database and those transmitted by a Member State with regard to a person, without prejudice to the requirement that Member States shall immediately check the results of the comparison pursuant to Article 26(4);

  • 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.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.