Phase IIb Clinical Trial definition

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.

Phase IIb Clinical Trial means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.

Phase IIb Clinical Trial means a Phase II Clinical Trial in any therapeutic Indication that is designed to determine the doses to be used in the Phase III Clinical Trials and to evaluate the efficacy/safety properties of the Compound.

Examples of Phase IIb Clinical Trial in a sentence

• For example, if a Phase IIb Clinical Trial is initiated without payment of the Successful Completion of Phase Clinical Study, then the Successful Completion of Phase Ib/IIa Clinical Study will be deemed to have occurred and will be paid in full upon payment of the milestone payable upon the submission of the first NDA filing.

• Upon completion of a Phase IIb Clinical Trial of the Product, such reports shall in any event be updated and promptly delivered to Lilly.

• Zealand Pharma shall promptly notify BI in the event that Zealand Pharma shall Initiate a Phase IIb Clinical Trial or commence the manufacture or sale of products in the same therapeutic class (ATC, third level) as the Products then under Development or being Commercialized under this Agreement, or being actively considered by the JRC for Development or Commercialization.

• Zealand Pharma shall promptly notify BI in the event that Zealand Pharma shall Initiate a Phase IIb Clinical Trial or commence the manufacture or sale of products in the same therapeutic class (ATC, third level) as the Products then under Development or being Commercialized under this Agreement, or being actively considered by the JRC for Development or Commercialization In such event, the provisions of Section 15.7.1 shall apply, mutatis mutandis.

• If the FDA determines at the end of Phase II debriefing meeting (which is expected to be held in May 2004) that more than one (1) Phase III Clinical Trial (in addition to the Phase II(b) Clinical Trial commencing in the first quarter of 2004, and any safety trial identified in Exhibit D) is required with respect to the Ragweed Product, Dynavax shall be solely responsible for all costs related to the second and any additional Phase III Clinical Trials.

More Definitions of Phase IIb Clinical Trial

Phase IIb Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b) and that is designed to support and immediately precede the initiation of a Phase III Clinical Trial without any further phase II trials by evaluating the dose-dependent effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study and to determine the common side effects and risks associated with the pharmaceutical product.

Phase IIb Clinical Trial means a controlled dose ranging Phase II Clinical Trial to evaluate further the efficacy and safety of a candidate drug in the target patient population and to define the optimal dosing regimen.

Phase IIb Clinical Trial means a human clinical trial in any country that is intended to preliminarily assess the effectiveness of a Collaboration Product for a particular indication, the clinical doses of such Collaboration Product for a Phase III Clinical Trial, and the safety profile of such Collaboration Product.

Phase IIb Clinical Trial means that portion of a clinical drug development program which provides a definitive, well controlled clinical trial of a Product in the relevant patient population for the purpose of determining its safety and efficacy in the proposed therapeutic indication, as more fully described in 21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent in any foreign country.

Phase IIb Clinical Trial means a controlled dose ranging clinical trial to evaluate further the efficacy and safety of a VEGF Product in the targeted patient population and to define the optimal dosing regimen.

Phase IIb Clinical Trial means that portion of the clinical development program which provides for the definitive, well controlled clinical trials of a Collaboration Product in patients for the purpose of determining the safe and effective dose range in the

Phase IIb Clinical Trial means a human clinical trial intended to identify the definite dose range for efficacy that would satisfy the requirements for a Phase 2 study as defined in 21 C.F.R. 312.21(b) (or any amended or successor regulation), or a Phase II study as defined in the ICH E8 Guideline (or any amended or successor regulations), or an equivalent study as defined in comparable regulations in any country or jurisdiction outside the U.S. (or any amended or successor regulations).