Comparator Drug definition

Comparator Drug means a placebo or comparator drug.
Comparator Drug means [*], or any other pharmaceutical product used as a comparator drug as the Parties may mutually agree after the Effective Date, for use in the Clinical Studies conducted for the Development of the Product in the Development Indication in accordance with the Development Plan.
Comparator Drug means any investigational or marketed product or placebo which is used as a reference in a clinical trial.

Examples of Comparator Drug in a sentence

  • Any other use of Sponsor Drug or Comparator Drug constitutes a material breach of this Agreement.

  • Institution and Principal Investigator will use Sponsor Drug or Comparator Drug only as specified in the Protocol.

  • Institution will return and/or destroy any unused Sponsor Drug or Comparator Drug, as applicable, at Sponsor’s expense.

  • Institution and Principal Investigator will adhere to Applicable Law requiring careful custody and dispensing of Sponsor Drug or Comparator Drug, as well as appropriate documentation of such activities.

  • Institution and Principal Investigator will not charge a Trial Subject or third-party payer for Sponsor Drug or Comparator Drug or for any services reimbursed by Sponsor or its designee under this Agreement.

  • Neither the Institution nor the Principal Investigator will directly or indirectly seek or receive compensation from Trial Subjects or third-party payers for any material, treatment or service that is required by the Protocol and provided or paid by Sponsor or its designee, including, but not limited to, Sponsor Drug, Comparator Drug, Trial Subject screening, infusions, physician and nurse services, diagnostic tests, and Sponsor Drug and/or Comparator Drug administration.

  • Institution and Principal Investigator will maintain appropriate control of supplies of Sponsor Drug or Comparator Drug and will not administer or dispense it to anyone who is not a Trial Subject, or provide access to it to anyone except Research Staff.

  • If required by the Protocol, and unless otherwise agreed in writing, Sponsor shall also provide the Comparator Drug.

  • Institution will use Sponsor Drug or Comparator Drug only as specified in the Protocol.

  • Institution and Principal Investigator will maintain appropriate control of supplies of Sponsor Drug or Comparator Drug and will not administer or dispense it to anyone who is not a Trial Subject, or provide access to it to anyone except subinvestigators or Trial research staff.


More Definitions of Comparator Drug

Comparator Drug means a placebo or comparator drug. Výklad pojmov Ak sa výraz kedykoľvek v tejto Zmluve napíše veľkým písmenom, má taký význam, ako sa uvádza nižšie. Množné xxxxx každého pojmu má zodpovedajúci význam. 1.1 „Platné právne predpisy“ znamenajú Smernicu o klinických skúšaniach 2001/20/EK, Nariadenie o klinických skúšaniach (EÚ) 536/2014 – v rozsahu, ktorý je uplatniteľný pre toto Skúšanie, Smernicu GCP 2005/28/EC, Všeobecné nariadenie o ochrane údajov (EÚ) 679/2016 a všetky následné verzie vyššie uvedených dokumentov, ako aj všetky uplatniteľné národné zákony, v ktorých sa uvádzajú ustanovenia vyššie uvedeného, GCPMP/ICH/135/95 Usmernenie o Správnej klinickej praxi, v znení neskorších predpisov, Helsinskú deklaráciu z roku 1964 v jej najnovšom znení a všetky ďalšie platné európske a národné zákony, pravidlá a nariadenia, vrátane, okrem iného povinných lokálnych zákonov, ktoré majú inak prednosť pri realizácii Skúšania podľa tejto Zmluvy, ako aj súvisiace Protikorupčné zákony (ako sa definujú nižšie). Aby sa predišlo pochybnostiam, Zmluvné strany potvrdzujú, že Platné zákony ďalej zahŕňajú zákony, ktorými xx xxxxx realizácia klinických skúšaní na Slovensku, predovšetkým zákon č. 362/2011 Zb. O liekoch a zdravotníckych pomôckach, v znení neskorších predpisov, a zákon č. 576/2004 Zb. O zdravotnej starostlivosti a službách súvisiacich s poskytovaním zdravotnej starostlivosti, v znení neskorších predpisov a platné zákony, ktorými xx xxxxx ochrana údajov na Slovensku, predovšetkým zákon č. 18/2018 Zb. O ochrane osobných údajov, v znení neskorších predpisov). 1.2 „Biologické vzorky“ znamenajú biologické vzorky (napr. krv, moč, tkanivo, sliny, atď.) získané od Subjektov Skúšania. 1.3 „Referenčný liek“ znamená placebo alebo
Comparator Drug means a placebo or comparator drug. 1.3. „Srovnávací léčivo” znamená placebo nebo srovnávací léčivý přípravek.
Comparator Drug. Comparator Drug means unexpired comparator drugs used for Global Development Plan activities after the Effective Date.
Comparator Drug means a placebo or comparator drug. 1.4 “CRF” shall mean a Case Report Form, which is a paper or electronic questionnaire used to collect all data generated in the course of the Trial for each Trial Subject. 1.5 “CRO” shall mean a Clinical Research Organization that is or will be engaged by Sponsor. Currently it is PSI CRO AG, Xxxxxxxxxxxxx 000x, 0000 Xxx, Xxxxxxxxxxx and its affiliates as described in the preamble. 1.6 “Effective Date” shall mean the last date of signature of the Agreement by the Parties. 1.7 “Equipment” shall have the meaning set forth in Section 23. 1.8 “Force Majeure” shall have the meaning set forth in Section 31. najnovšom znení a všetky ďalšie platné európske a národné zákony, pravidlá a nariadenia, vrátane, okrem iného povinných lokálnych zákonov, ktoré majú inak prednosť pri realizácii Skúšania podľa tejto Zmluvy, ako aj súvisiace Protikorupčné zákony (ako sa definujú nižšie). Aby sa predišlo pochybnostiam, Zmluvné strany potvrdzujú, že Platné zákony ďalej zahŕňajú zákony, ktorými xx xxxxx realizácia klinických skúšaní na Slovensku, predovšetkým zákon č. 362/2011 Zb. O liekoch a zdravotníckych pomôckach, v znení neskorších predpisov, a zákon č. 576/2004 Zb. O zdravotnej starostlivosti a službách súvisiacich s poskytovaním zdravotnej starostlivosti, v znení neskorších predpisov a platné zákony, ktorými xx xxxxx ochrana údajov na Slovensku, predovšetkým zákon č. 18/2018 Zb. O ochrane osobných údajov, v znení neskorších predpisov). 1.2 „Biologické vzorky“ znamenajú biologické vzorky (napr. krv, moč, tkanivo, sliny, atď.) získané od Subjektov Skúšania. 1.3 „Referenčný liek“ znamená placebo alebo porovnávací liek. 1.4 „CRF“ znamená Záznamový formulár, čo je dotazník v papierovej alebo elektronickej forme, ktorý sa používa na zhromaždenie údajov zistených v priebehu Skúšania o každom Subjekte Skúšania. 1.5 „CRO“ znamená Klinickú výskumnú organizáciu, ktorú si najal alebo si najme Zadávateľ. Aktuálne je to XXX XXX XX, Xxxxxxxxxxxxx 000x, 0000 Xxx, Švajčiarsko a jej pobočky, ako sa to uvádza v preambule. 1.6 „Dátum účinnosti” znamená dátum získania posledného podpisu tejto Zmluvy Zmluvnými stranami. 1.7 "Vybavenie” má význam, aký sa uvádza v Článku 23.

Related to Comparator Drug

  • Comparator Group is defined as the following nine U.S. based carriers including, AirTran Airways, Inc., Alaska Air Group, Inc., AMR Corporation, Continental Airlines, Inc., Delta Air Lines Inc., JetBlue Airways Corporation, Southwest Airlines Co., US Airways Group, Inc. and UAL Corporation.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Single tomogram system means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Therapeutically equivalent drug products means drug products that contain the same active

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Loop Concentrator/Multiplexer or "LCM" is the Network Element that does one or more of the following: aggregates lower bit rate or bandwidth signals to higher bit rate or bandwidth signals (multiplexing); disaggregates higher bit rate or bandwidth signals to lower bit rate or bandwidth signals (demultiplexing); aggregates a specified number of signals or channels to fewer channels (concentrating); performs signal conversion, including encoding of signals (e.g., analog to digital and digital to analog signal conversion); or in some instances performs electrical to optical (E/O) conversion. LCM includes DLC, and D4 channel banks and may be located in Remote Terminals or Central Offices.

  • Multiple tomogram system means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.

  • Disinfection profile means a summary of Giardia lamblia inactivation through the treatment plant.

  • Quantitative fit test or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Motor-driven cycle means every motorcycle that has a gasoline engine that (i) displaces less than

  • 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.

  • Drug addiction means a disease characterized by a

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Riprap means small, broken stones or boulders placed compactly or irregularly on dykes or similar embankments for protection of earth surfaces against wave action or current;

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.

  • Category 4 Data is data that is confidential and requires special handling due to statutes or regulations that require especially strict protection of the data and from which especially serious consequences may arise in the event of any compromise of such data. Data classified as Category 4 includes but is not limited to data protected by: the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), 45 CFR Parts 160 and 164; the Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. §1232g; 34 CFR Part 99; Internal Revenue Service Publication 1075 (xxxxx://xxx.xxx.xxx/pub/irs-pdf/p1075.pdf); Substance Abuse and Mental Health Services Administration regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2; and/or Criminal Justice Information Services, 28 CFR Part 20.