CLINICAL APPLICATIONS definition

CLINICAL APPLICATIONS means all human and veterinary diagnostic, therapeutic and prophylactic applications (including vaccines and ex vivo expansion of cells that are then used in vivo) in the FIELD.
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CLINICAL APPLICATIONS means the analysis of a patient sample for purposes of reporting of a patient result.
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Examples of CLINICAL APPLICATIONS in a sentence

  • This pulsing is repeated till such time as the temperature in the target at the end of last pulse exceeds its threshold limit.[7] CLINICAL APPLICATIONS The present clinical applications in skin conditions and cosmetology which most concern a plastic surgeon canPatil and Dhami be grossly divided into following five categories:1.

  • THE SOFTWARE LICENSED AND CLOUD SERVICES PROVIDED HEREUNDER ARE NOT DESIGNED OR INTENDED FOR CLINICAL APPLICATIONS OR USE IN ANY APPLICATION IN WHICH THE FAILURE OF THE SOFTWARE OR CLOUD SERVICES COULD LEAD TO PERSONAL INJURY OR DEATH.

  • PRINCIPAL INVESTIGATOR AND LICENSEE ACKNOWLEDGE THAT THE DNA SEQUENCES HAVE BEEN DESIGNED FOR RESEARCH PURPOSES ONLY AND HAVE NOT BEEN REVIEWED OR APPROVED BY THE FOOD AND DRUG ADMINISTRATION OR BY ANY OTHER AGENCY, AND FURTHER ACKNOWLEDGE THAT CLINICAL APPLICATIONS ARE NEITHER RECOMMENDED NOR ADVISED.

  • The first report is due March 1, 2009, and subsequent reports shall be made every twelve (12) months thereafter until such time as the LICENSED INVENTION has been brought to the point of PRACTICAL APPLICATION in CLINICAL APPLICATIONS.

  • EMERGENCY RESUSCITATION KIT CLINICAL APPLICATIONS An emergency resuscitation kit is design to use in the hospitals for all emergency situations where respiratory support is needed.The purpose of the kit is to provide basic standard set of equipments.

  • Each team member was asked to rate the appropriateness of each treatment option (surgery, radiotherapy, chemo- therapy, combination therapy, or supportive care only) on a standard scale of 1 to 9 as used in other studies.11 Nine respiratory physicians, 3 oncologists, and 3 CLINICAL APPLICATIONS 603 thoracic surgeons participated in the study, with each specialty represented at each meeting.Because of time pressures, only 1 case could be stud- ied at each meeting.

  • PG&E ET buys natural gas from producers, marketers, and other parties.

  • III.A.3. FUTURE POTENTIAL CLINICAL APPLICATIONS Other indications for the system are currently being investigated.

  • An owner or operator or any other person authorized to perform post-closure care may request reimbursement for post-closure care expenditures by submitting itemized bills to the director.

  • Adrian Raine, Antisocial Behavior and Social Psychophysiology, in SOCIAL PSYCHOPHYSIOLOGY AND EMOTION: THEORY AND CLINICAL APPLICATIONS 231 (Hugh L.

Related to CLINICAL APPLICATIONS

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • 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.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • 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;

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

  • 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 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.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • 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.

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • 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 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.

  • 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 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.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • 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.