Phase IIb Clinical Study definition

Phase IIb Clinical Study means that portion of a PHASE II CLINICAL STUDY involving controlled dose ranging to evaluate the efficacy and safety of an investigational new drug in the target patient population and to define the optimal dosing regimen.

Phase IIb Clinical Study means a Phase II Clinical Study of the SST Product initiated after completion of the End of Phase IIA FDA Meeting and in which the SST Product is used by study subjects outside the clinical setting (e.g., at home).

Phase IIb Clinical Study means Trubion's TRU-015 Protocol 15002.

Examples of Phase IIb Clinical Study in a sentence

• Reimbursement of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies.

• With respect to any Product that is subject to Joint Development pursuant to Section 5.4(c) above, the JDC for such Product Candidate shall discuss and determine whether the Product Candidate is ready for Phase IIb Clinical Studies, and if not, what additional Development activities are required prior to the conduct of a Phase IIb Clinical Study.

• If such Senior Officers cannot resolve such matter within a [***]-day period, then the Phase IIb Clinical Study for such Product Candidate [***].

• Subject to Section 5.5(a), which sets forth the decision making process as to the commencement of a particular jointly conducted Phase IIb Clinical Study, the Parties shall not commence any Phase IIb Clinical Study for a Development Candidate unless and until such Development Candidate is first designated as a Product Candidate pursuant to this Section 4.2(e)(ii) for a particular Indication.

• Where the Pre-Phase III Election Notice under Section 5.6(c)(iv) is received prior to the first data analysis (including any interim analysis as part of the statistical plan) of the Phase IIb Clinical Study, payment of the Pre-Phase III Opt-In Payment shall render such Product Candidate a Product Candidate Developed under a Joint Phase IIb Plan for all purposes, including joint decision making as to the readiness for Phase III Development and the Phase III Plan under Sections 5.5(c) and 5.5(d).

More Definitions of Phase IIb Clinical Study

Phase IIb Clinical Study means a clinical study, other than the Phase IIa Study and other than any Phase III Clinical Study, that is intended to test the effectiveness of a Licensed Product for a specific indication in patients with the disease or condition under study and to establish the dosing regimen for use in a Phase III Clinical Study of such Licensed Product for a specific indication. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

Phase IIb Clinical Study means a Phase II Clinical Study that is intended to establish the dosing regimen for use in a Phase III Clinical Study of a Licensed Product for a specific indication.

Phase IIb Clinical Study means Phase II Clinical Study to study efficacy.

Phase IIb Clinical Study 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 Study means a phase IIb Clinical Study [ * ].

Phase IIb Clinical Study means a human clinical trial in any country that is conducted in accordance with GCPs and is intended to evaluate the effectiveness of a product in dose escalation for a particular indication or indications in patients with the disease or indication under study for purposes of identifying the appropriate dose for a Phase III Clinical Study, or that would otherwise satisfy the requirements of 21 CFR §312.21(b) or any successor regulation thereto or foreign equivalents.

Phase IIb Clinical Study. . Phase IIB Clinical Study means a human clinical study designed to evaluate further any preliminary efficacy observed for, and the safety of, a Licensed Product in the target population or to provide data that may be useful in the design of subsequent studies of the Licensed Product such as Phase III Clinical Studies.