First Patient In definition

First Patient In or “FPI” means the date the first human subject or patient is qualified for acceptance into a human clinical trial that is sponsored by, or otherwise conducted by or on behalf of, Telix, an Affiliate thereof, or any Sublicensee or for which any of the foregoing enjoy any rights to any data or results.
Sample 1Sample 2Sample 3
First Patient In or “FPI” means, with respect to a Clinical Trial of Product, the date that the first subject is dosed in such Clinical Trial.
Sample 1

Examples of First Patient In in a sentence

  • CRO - Contract Research Organization FPI - First Patient In JDC - Joint Development Committee LPO - Last Patient Out MRD - Multiple Rising Dose OLE - Open label extension SRD - Single Rising Dose THE - Cortisol: tetrahydrocortisone THF - tetrahydrocortisol ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

  • Omnicare CR Activities to Commence June 2005 Drug Shipment to Site **** First Patient In **** Maximum Tolerable Dose — Data Available for Sponsor to discuss with the FDA **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

  • First Patient In (WBS 1.4.2.1) Last Patient In (WBS 1.4.2.2) Last Patient Out (WBS 1.4.2.5) - Study protocol for BARDA review/approval prior to submission to FDA (WBS 1.4.2.1).

  • The overall study isexpected to last around 14 months (from First Patient In until Last Patient Last Visit).Sponsor/StudyChairThis is a TRIO-sponsored study which will be chaired by Dr. Dennis Slamon (Professor of Medicine, Chief, Division of Hematology-Oncology, UCLA's Department of Medicine, CA,USA).

  • Tempest’s product development programs consist of the following: Definitions:HCC: hepatocellular carcinoma; RCC: renal cell carcinoma; CCA: cholangiocarcinoma; CRC: colorectal cancer; FPI: First Patient In; RP2D: Recommended Phase 2 Dose; DC: Development Candidate; ORR: Objective Response Rate.

  • The study is planned to start in February 2014 (i.e. First Patient In) and to stop in July 2014 (Last patient Out).

  • Prior to First Patient In occurring in the first Combined Therapy Trial using the Combination, the Parties shall execute a separate pharmacovigilance agreement that defines the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting for the Compounds and the Combination used in a Study (the “Pharmacovigilance Agreement”).

  • Therefore, recruitment of patients with a HER2-low/ HR+ tumor will be stopped if 360 patients with HR+ tumor have been recruited.The planned overall duration of patient recruitment (First Patient In (FPI) to Last Patient In (LPI)) is approximately 2.25 years.

  • Tempest’s product development programs consist of the following: Definitions:HCC: hepatocellular carcinoma; RCC: renal cell carcinoma; CCA: cholangiocarcinoma; CRC: colorectal cancer; FPI: First Patient In; RP2D: Recommended Phase 2 Dose; DC: Development Candidate; ORR: Objective Response Rate.

  • MUDr. Xxxxxxxx Xxxxxxxxxxxx, Ph.D. Name / Xxxxx: Date / Datum: TIMELINES ČASOVÉ HARMONOGRAMY First Site Activated (Projected): 12Dec19 Last Site Activated (Projected): 10Dec2021 FPFV (Screened) (Actual): 18Dec2019 First Patient In (Actual): 20Dec2019 Last Patient In (Projected):03Jun2022 Last Patient Last Visit incl.

Related to First Patient In

  • Stage-Four Advanced, Metastatic Cancer means a cancer that has spread from the primary or original site of the cancer to nearby tissues, lymph nodes, or other areas or parts of the body.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Day Patient means an Insured Person receiving Medical Services or treatments given in a medical clinic, day case procedure centre or Hospital where the Insured Person is not in Confinement.

  • 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.

  • 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.

  • 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 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.

  • Collaborating physician means the physician who,

  • 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.

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

  • 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.

  • Assisted outpatient treatment or "AOT" means the categories of outpatient services ordered by the court under section 468 or 469a. Assisted outpatient treatment may include a case management plan and case management services to provide care coordination under the supervision of a psychiatrist and developed in accordance with person-centered planning under section 712. Assisted outpatient treatment may also include 1 or more of the following categories of services: medication; periodic blood tests or urinalysis to determine compliance with prescribed medications; individual or group therapy; day or partial day programming activities; vocational, educational, or self-help training or activities; assertive community treatment team services; alcohol or substance use disorder treatment and counseling and periodic tests for the presence of alcohol or illegal drugs for an individual with a history of alcohol abuse or substance use disorder; supervision of living arrangements; and any other services within a local or unified services plan developed under this act that are prescribed to treat the individual's mental illness and to assist the individual in living and functioning in the community or to attempt to prevent a relapse or deterioration that may reasonably be predicted to result in suicide, the need for hospitalization, or serious violent behavior. The medical review and direction included in an assisted outpatient treatment plan shall be provided under the supervision of a psychiatrist.

  • Trafficking means offering, attempting to engage, or

  • Participating Clinical Laboratory means a Clinical Laboratory which 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.

  • 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.

  • 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.

  • Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act.

  • 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).

  • 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.

  • 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.

  • Therapeutic interchange means an authorized exchange of therapeutic alternate drug products in accordance with a previously established and approved written protocol.

  • Outpatient treatment means mental health or substance abuse treatment services rendered to a

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist 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.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Clinical Trial means any human clinical trial of a Product.

  • Designated reception site means the designated place for the reception, staging, integration, and onward movement of contractors deploying during a contingency. The designated reception site includes assigned joint reception centers and other Service or private reception sites.