First Human Dose definition

First Human Dose means the first instance in which a dose of a Licensed Product is administered to a human being in a clinical trial.
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First Human Dose means the first dose administered to a human subject according to a clinical plan consistent with the dosing company's regular practice for clinical trials designed to support regulatory approval in any country.
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Examples of First Human Dose in a sentence

  • Celine Pitou Modelling of PK/Efficacy/Toxicity in rats to help design a First Human Dose for a cell cycle inhibitor X 096.

  • The First Human Dose and PK trial (NN7008-3522) comparing N8 and Advate® has been completed.

  • The First Human Dose (FHD) trial (ZP4207-14013) was finalized in April 2015.

  • Inactivation of enveloped viruses like HIV, HBV and HCV is ensured by detergent treatment (included in the initial purification step) and removal of prions and non-enveloped viruses like Parvovirus B19 is ensured by a 20-nm filtration step prior to the size exclusion step.12, 13 The First Human Dose and PK trial (NN7008-3522) results from 23 patients showed mean PK profiles of turoctocog alfa comparable to Advate® within the defined limits of comparability.

  • The obligation to provide such reports shall begin upon the First Human Dose for such product and shall continue until (i) the first sale of such product, or (ii) development of such product is terminated.

  • First Human Dose (FHD) Study of the oral transforming growth factor-beta (TGF-β) receptor I kinase inhibitor LY2157299 in patients with treatment-refractory malignant glioma.

Related to First Human Dose

  • continuing professional development means the continuing professional development contemplated in section 32;

  • Allied Health Professional means a person registered as an allied health professional with the Health Professions Council;

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

  • Human being means a person who has been born and is alive.

  • Seattle Human Resources Director means the director of the Seattle Department of Human Resources or his or her designated management representative.

  • Health and Human Services or “HHS” includes HHSC and DSHS.

  • Local Health Board (“Bwrdd Iechyd Lleol”) means a Local Health Board established under section 11 of the National Health Service (Wales) Act 2006 (c.42);

  • Non-Executive Director Means any director who is not an Executive Director.

  • College board means the state board for community and

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

  • Licensed mental health professional or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.

  • Non-Executive Directors means the Directors who are not in whole time employment of the Company.

  • Mental health professional means a psychiatrist,

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

  • Designated mental health professional means a mental health

  • Municipal Finance Management Act means the Local Government: Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • Health professional means any of the following:

  • Participating Clinical Professional Counselor means a Clinical Professional Counselor who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Qualified mental health professional means a licensed medical practitioner or any other person meeting the qualifications specified in OAR 309-019-0125.

  • Human use means the internal or external administration of radiation or radioactive material to human beings.

  • Health and Human Services Commission or “HHSC” means the administrative agency established under Chapter 531, Texas Government Code, or its designee.

  • Radiologic technologist means an individual, other than a licensed doctor of medicine, osteopathy,

  • Health Board means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978;

  • Campus police officer means a school security officer designated by the board of education of any school district pursuant to K.S.A. 72-6146, and amendments thereto.

  • Competent and reliable scientific evidence means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

  • Rural health clinic means a rural health clinic as defined under section 1861 of part C of title XVIII of the social security act, chapter 531, 49 Stat. 620, 42 U.S.C. 1395x, and certified to participate in medicaid and medicare.