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 designed to evaluate the safety and efficacy of a Licensed Product in a target patient population with dosing duration, clinical endpoints, and sample size appropriate to enable the design of Phase III Clinical Trials.

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.

• Baseline Characteristics in the Phase III Double- blind Trials are Similar to the Phase IIb Clinical Trial • Phase III baseline curvature and Peyronie’s disease bother are comparable to the phase IIb baseline.

• 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.

More Definitions of Phase IIb Clinical Trial

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.

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 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 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 a clinical trial that is initiated after the release of data concerning a completed Phase I Clinical Trial and which has the primary objective to collect data on dosages and additional data on safety, and make an initial demonstration of clinical efficacy in a target population for a specific disease or condition under study. In a Phase IIb Clinical Trial, the trial results are to be assessed for statistically significant differences between groups for clinical endpoints considered as a basis for registration, which may include generally accepted surrogate pharmacodynamic endpoints. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Phase IIb Clinical Trial. “Phase II Clinical Trial” shall mean a human clinical trial for which the primary endpoints include a preliminary determination of efficacy and safety in patients being studied as required in 21 C.F.R. §312.21(b), or similar clinical study in a country other than the United States. “Phase IIa Clinical Trial” shall mean a Phase II Clinical Trial whose primary objective is to explore safety and tolerability, pharmacokinetic and pharmacodynamic effects in human patients in a study [*]. “Phase IIb Clinical Trial” shall mean a clinical trial that is initiated after the release of data concerning a completed Phase I Clinical Trial and which has the primary objective to collect data on dosages and additional data on safety, and make an initial demonstration of clinical efficacy in a target population for a specific disease or condition under study. In a Phase IIb Clinical Trial, the trial results are to be assessed for statistically significant differences between groups for clinical endpoints considered as a basis for registration, which may include generally accepted surrogate pharmacodynamic endpoints. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

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).