Dosed definition

Dosed means a patient enrolled and randomized in the 301 Clinical Trial has been administered the Product or a placebo, in any case, in accordance with the protocol for the 301 Clinical Trial; provided, that no patient shall be counted more than once for purposes of determining whether the Patient Dosage Threshold has been satisfied; provided, further, that if a patient is Dosed and subsequently ceases to participate in the 301 Clinical Trial, that patient shall continue to be counted as Dosed for purposes of determining whether the Patient Dosage Threshold has been satisfied.
Dosed has the meaning set forth in Section 8.
Dosed means a patient enrolled and randomized in a Phase 1 Clinical Trial or Phase 2 Clinical Trial, as applicable has been administered a Product or a placebo, in any case in accordance with the protocol for such Phase 1 Clinical Trial or Phase 2 Clinical Trial, as applicable.

Examples of Dosed in a sentence

  • PK analysis set Dosed patients for whom concentration time data/PK profile data for AZD5363 or paclitaxel has been obtained.

  • Schedule 8.5 Form of Joint Press Release Forest Laboratories and Adamas Pharmaceuticals Enter into Licensing Agreement for the Development and Commercialization of a Fixed Dosed Combination of Namenda XR® and Donepezil for Alzheimer’s Disease NEW YORK & EMERYVILLE, CA — Forest Laboratories, Inc.

  • Dosed means that the clinical trial subject has received their first dose of Investigational Drug.

  • As part of the “Vancomycin Dosed per Collaborative Practice Protocol” order in the EMR system, the practitioner will select an initial weight-based loading dose of 25 mg/kg (based on total body weight).

  • Company’s Commercially Reasonable Efforts shall include achieving the following objectives within the time periods designated below following the Effective Date: Phase II Studies, First Patient Dosed Dec.


More Definitions of Dosed

Dosed is defined in Section 5.2(b).
Dosed means, with respect to the above milestone events, administration of the first dose of ISIS-TTRRx or placebo to the applicable patient in the Phase 2 PoC Trial in accordance with the TTR Registration-Directed Program Documents. Notwithstanding Section 5.8.2 of the Agreement, Isis will send GSK a written notice promptly following the date when the “Initiation of the Phase 2 PoC Trial” Milestone Event in TABLE X is achieved, and the $7,500,000 milestone payment will be due within [***] Business Days of GSK’s receipt of the invoice.
Dosed with a Licensed Product means the first administration to a patient in a given clinical trial of (A) such Licensed Product; (B) another active pharmaceutical ingredient for the treatment of the same indication as such Licensed Product; or (C) a placebo for such Licensed Product.

Related to Dosed

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.