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.
First Patient In means the first participant enrolled in a clinical study;
First Patient In means the dosing of the first patient enrolled in a clinical study.

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.

  • 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 24b-2 of the Securities Exchange Act of 1934, as amended.

  • MUDr. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇, Ph.D. Name / ▇▇▇▇▇: 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.

  • 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”).

  • ICON Involvement Begins 01 June 2007 First Patient In (FPI) * Last Patient In (LPI) * Treatment/Follow-up Ends: Last Patient Out (LPO) * Final Database Lock * Closeout Visits Completed * ICON Involvement Ends 31 March 2011 The timeline shown above is based on the assumption that some sites may have FPI August 21, 2007, with the majority of sites should have FPI occur by October 2007.

  • Kangzhe Budenofalk 2mg ▇▇▇▇ & Salofalk tablets vs Budenofalk placebo foam & Salofalk tablets 03.12.14 301.011.18 301.101.212 IMP = Investigational Medicinal Product FPI = First Patient In LPO = Last Patient Out CSR = Clinical Study Report *The date is estimated by current situation SAG-65/BIO I Clinical Pharmacokinetics study of Mesalazine gastro-resistant prolonged-release Granules.

  • The parties acknowledge and agree that termination is being affected prior to the Milestone payment due for First Patient In (FPI).

  • Timelines w Set-up Activities End October 2005 w Regulatory / EC Submissions End October 2005 w First Patient Included End January 2006 w Last Patient Included End January 2009 w Last Patient Last Visit End August 2009 w Study Close-out End October 2009 NB These timelines assume that Ethics Committee and Regulatory Authority approvals are granted, and that the study drug is available on-site before First Patient In. GENTIUM - VOD - Defibrotide Study - Proposal no.

  • 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).


More Definitions of First Patient In

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.

Related to First Patient In

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.