Phase I Study Initiation means the first human clinical trial conducted on normal volunteers and designed to evaluate safety of a product; provided, however, with respect to oncology, "Phase I Study Initiation" means the first human clinical trial conducted on patients with cancer who have no therapeutic options other than experimental therapy or normal volunteers.
Phase I Study Initiation means the dosing of the first subject in a clinical trial, whether conducted in subjects in the United States or outside the United States, that falls within the definition of a “Phase 1” study in Section 312.21(a) of Title 21 of the U.S. Code of Federal Regulations, as amended from time to time, or the equivalent in any foreign country, and is designed to determine the metabolism and pharmacologic actions of the subject drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on safety and effectiveness, as well as to obtain sufficient information about the drug’s pharmacokinetics and pharmacological effects to permit the design of well-controlled, scientifically valid, Phase II studies.
Phase I Study Initiation means the first dose administered to the first patient in the first human clinical trial conducted, whether in the United States or outside the United States, in accordance with Title 21, Section 312.21(a) of the U.S. Code of Federal Regulations (as amended or replaced) or equivalent statute in the country in which the trial is being conducted.
More Definitions of Phase I Study Initiation
Phase I Study Initiation means the first human clinical trial conducted on normal volunteers and designed to evaluate safety of a product; provided, however, with respect to oncology, “Phase I Study Initiation” means the first human clinical trial conducted on patients with cancer who have no therapeutic options other than experimental therapy or normal volunteers.
Phase I Study Initiation means the first human clinical trial conducted on normal volunteers and designed to evaluate safety of a product.