Phase IIb Study definition

Phase IIb Study means a controlled dose ranging clinical trial to evaluate further the efficacy and safety of a candidate drug in the targeted patient population and to define the optimal dosing regimen.

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Phase IIb Study means the definitive study or studies in patients with the disease or condition designed to evaluate clinical efficacy and safety for such Alliance Product for one or more indications, and/or to obtain the dosage regimen required for subsequent Phase III Studies.

Phase IIb Study means a human clinical trial of a product containing the Compound, the principal purpose of which is to find the dose range in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise.

Examples of Phase IIb Study in a sentence

For the avoidance of doubt and without prejudice to other activities, the following activities will be deemed in the best interest of the Product: (i) an expanded clinical program scope; (ii) additional safety studies, including drug-drug interaction studies and special population studies; (iii) reformulation efforts; or (iv) business development efforts following initiation of a Phase II(b) Study.
For example, if LICENSEE, its Affiliates or sublicensees discontinues Development Work on the Product containing the MT-210 Compound after the Onset of a Phase II(b) Study, LICENSEE will not have to make a milestone payment on the Product containing such back-up Compound that it develops to replace the Product containing MT-210 Compound unless and until there is an Onset of a Phase III Study utilizing the Product containing such back-up Compound.
Promptly following the completion of the analysis of the secondary end point of the [Ongoing Phase IIb Study], Licensor shall provide to Licensee a complete data package therefor, and such other information as Licensee may reasonably request in connection with its evaluation of such data.
Notwithstanding the foregoing, a clinical trial for a Product shall be deemed successfully completed no later than the dosing of the first patient in any later clinical trial for such Product (e.g., Pivotal Study or later trial with respect to a Phase IIb Study) and a Pivotal Study for a Product shall be deemed successfully completed upon the filing of an NDA with respect to such Product.
As consideration for granting access to certain know-how and information, including the Interim Phase IIb Study Report relating to Lupuzor, for granting the Option and for the other representations, warranties and covenants set forth herein, Cephalon shall pay to ImmuPharma an amount of fifteen million US Dollars (US$15,000,000) (the “Know-How Access and Option Payment”).

More Definitions of Phase IIb Study

Phase IIb Study means the current clinical trial FHRT 11 using a Product conducted in Australia under a US IND application number (**).

Phase IIb Study means a further Phase II Study for a Licensed Product for the same Indication that is intended to identify the definite dose range for efficacy at the primary endpoint for that Indication.

Phase IIb Study means a dose ranging study conducted in patients with the target disease.

Phase IIb Study. Phase III Study", and Biologics or Product License Application (also referred to as a PLA) shall mean these terms as described in the laws and regulations of the U.S. Food and Drug Administration of the Department of Health and Human Services.

Phase IIb Study means an efficacy and safety study of a Collaboration Product or Licensed Product to evaluate further any preliminary efficacy observed for, and the safety of, the Collaboration Product or Licensed Product in the target patient population and/or to provide data that may be useful in the design of subsequent studies of the Collaboration Product or Licensed Product such as Phase III Studies or Pivotal Trials, including, but not limited to dose level, dose ratio, and dose regimen.

Phase IIb Study. . Phase IIB Study means a controlled dose ranging clinical trial to evaluate further the efficacy and safety of a Joint DDC in the target patient population and to define the optimal dosing regimen.

Phase IIb Study means a study in patients designed to compare the safety and efficacy of a range of dosing regimens of the Product, and which is not a Phase III Study;