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.

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 dose ranging study conducted in patients with the target disease.

Examples of Phase IIb Study in a sentence

• Peyronie’s Phase IIb Study Design Arm Study Drug Plaque Modeling Targeted Number of Patients A XIAFLEX yes 45 B Placebo yes 15 C XIAFLEX no 45 D Placebo no 15 120 • Patients will be randomized in a 3:1 ratio of XIAFLEX to placebo and a 1:1 ratio to receive penile plaque modeling or no modeling.

• Peyronie’s Phase IIb Study Top-line Data Expected in 4Q09 • Study designed to assess the safety and efficacy with XIAFLEX.

• Automobile Liability Insurance covering all owned, non-owned and hired vehicles used in connection with the work, in an amount not less than $5,000,000 combined single limit per occurrence for bodily injury and property damage.

• A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects.

• The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis.

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 human clinical trial of a product, the principal purpose of which is to find the optimally safe and effective 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.

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 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;

Phase IIb Study. Phase II(b) Study shall mean a study of an siRNA or Product to evaluate further any preliminary efficacy observed for, and the safety of, the siRNA or Product in the target patient population and/or to provide data that may be useful in the design of subsequent studies of the siRNA or Product such as Phase III Studies or Pivotal Studies.