Thymira Validation definition

Thymira Validation means a Validation Study completed and ready for submission to New York State by JS Genetics, Inc. (or an equivalent New York State-certified organization), which has been reviewed and approved by PDI before submission, showing that the Thymira assay meets analytical and clinical validation requirements using standard and well-accepted NY CLIA approval guidelines and NY CLIA submission standards.

Examples of Thymira Validation in a sentence

  • Research Needs As part of the US Shorebird Conservation Plan, an associated technical report was developed that outlines priority areas of research in shorebird ecology and habitat management (Oring et al.

  • Except with respect to achieving IP Clearance, NY CLIA Approval and Thymira Validation, PDI shall have the right to take the lead in such efforts and Prolias agrees to support PDI in such efforts as may reasonably be requested by PDI, and not to pursue any such efforts unilaterally without prior consultation with and authorization by PDI as to any such efforts.

Related to Thymira Validation

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Step therapy means a protocol or

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Nonambulatory means a person who immediately and without the aid of another is not physically and mentally capable of traveling a normal path to safety, including the ascent and descent of stairs.

  • 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.

  • In Patient Care means treatment for which the insured person has to stay in a hospital for more than 24 hours for a covered event.

  • 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;

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Gene Therapy means a product or service for the treatment or prevention of a disease that utilizes ex vivo or in vivo delivery (via viral or nonviral gene transfer methods or systems) of Genetic Material, including any cell incorporating Genetic Material.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Antipsychotic medications means that class of drugs

  • Radiation therapist means a person, other than a Licensed Practitioner or Nuclear Medicine Technologist, who applies radiation to humans for therapeutic purposes under the supervision of a Licensed Practitioner;

  • Fabrication means making up data or results and recording or reporting them.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Nonprescription medication means a drug or medication authorized pursuant to federal or state law for general distribution and use without a prescription in the treatment of human disease, ailments, or injuries.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Nursing home-type patients means a patient who has been in hospital more than 35 days, no longer requires acute hospital care, cannot live independently at home or be looked after at home, and either cannot be placed in a nursing home or a nursing home place is not available.

  • Veterinarian means a veterinarian authorized by law to practice veterinary medicine in this State.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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.

  • 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.

  • Psychotropic medication means medication the prescribed intent of which is to affect or alter thought processes, mood, or behavior including but not limited to anti-psychotic, antidepressant, anxiolytic (anti-anxiety), and behavior medications. The classification of a medication depends upon its stated, intended effect when prescribed.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Moving beam radiation therapy means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external