Proof of Concept Study means a Phase 2 Clinical Trial that is appropriately designed (i) to demonstrate efficacy in the disease to be studied through relevant primary and/or secondary efficacy endpoints as described in the Proof of Concept Development Plan and (ii) to allow dose selection and support generation of efficacy data that would allow movement of the product into a Phase 3 Clinical Trial that would support the regulatory strategy of seeking Regulatory Approval in both the AVEO Territory and the EU. For purpose of clarity, a clinical study meeting the requirements of this definition will be considered a Proof of Concept Study when completed whether or not the endpoints of the study are actually met.
Proof of Concept Study means a human clinical trial for a particular Phase I Ready Compound that meets the requirements of 21 C.F.R. Section 312.21(b) and is intended to explore [ * ].
Proof of Concept Study. Proof of Concept Study means a Phase II Clinical Trial, the design of which is intended to demonstrate achievement of a primary efficacy endpoint as established by the Parties and approved by the JSC in a clinical trial filed with, and permitted to proceed by, the applicable Regulatory Authority.
Examples of Proof of Concept Study in a sentence
Implantable, Programmable, and Wireless Device for Electrical Stimulation of the Dorsal Root Ganglion in Freely-Moving Rats: A Proof of Concept Study.
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet].
Mattsson, Pooling and Analysis of Published in Vitro Data: A Proof of Concept Study for the Grouping of Nanoparticles, Int.
Sleep EEG Derived From Behind-the-Ear Electrodes (cEEGrid) Compared to Standard Polysomnography: A Proof of Concept Study.
Supporting Parents Who Have Youth with Emotional Disturbances Through a Parent-to-Parent Support Program: A Proof of Concept Study Using Random Assignment.
More Definitions of Proof of Concept Study
Proof of Concept Study or “POC Study” means a human clinical trial of a Compound or Product conducted by Ultragenyx or any Affiliate to demonstrate preliminary clinical safety and efficacy with a small number of strictly selected patients.
Proof of Concept Study means an open label, repeat dose, dose escalation clinical study of a Product in adult humans with short bowel syndrome.
Proof of Concept Study means, with respect to each Development Product or Substitute Product (if applicable), a Phase I study rolling over into a Phase II study which includes a safety evaluation component (Phase I) designed to determine a safe and practical dose for further evaluation of the Development Product or Substitute Product (if applicable), and an efficacy evaluation component (Phase II) in which patients are evaluated for evidence of clinical activity of the Development Product or Substitute Product (if applicable) administered at a safe and practical dose. This Phase I study rolling over into a Phase II study shall include sufficient eligible patients as outlined in an IND submitted to Regulatory Authorities in writing. This Phase I study rolling over into a Phase II study will be conducted in approximately twenty-five (25) to thirty (30) evaluable patients.
Proof of Concept Study is defined in Section 6.1.
Proof of Concept Study means [* * *].
Proof of Concept Study means a Phase I /IIa Clinical Study.
Proof of Concept Study has the meaning set forth in Section 5.1.2.