Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.
Phase I Trial means a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(a) (as amended or any replacement thereof), including an equivalent clinical trial conducted in a country other than the United States.
Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.
Examples of Phase I Trial in a sentence
Results of a Phase I Trial of Concurrent Chemotherapy and Escalating Doses of Radiation for Unresectable Non-Small Cell Lung Cancer.
A Phase I Trial of the Novel Proteasome Inhibitor PS341 in Advanced Solid Tumor Malignancies.
Subsequently, the Bankruptcy Court adjourned the Phase I Trial to a date to be determined.
Ct. Los Angeles County, March 24, 2005, Case No. BS 080548), Statement of Decision from Phase I Trial on Petitions for Writ of Mandate, pp.
Phase I Trial of the Proteasome Inhibitor PS-341 in Patients with Refractory Hematologic Malignancies.
More Definitions of Phase I Trial
Phase I Trial means, with respect to the United States, any human clinical trial, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as required under 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, an equivalent clinical study.
Phase I Trial means a human clinical trial (whether a phase la or a phase lb trial) in any country of the type described in 21 C.F.R. §312.21(a), or an equivalent clinical study required by a Regulatory Authority outside of the United States.
Phase I Trial means any human clinical trial of a CAR Product that satisfies the requirements of 21 C.F.R. 312.21(a), or other comparable regulation imposed by the FDA, the EMA or their foreign counterparts for an equivalent clinical trial in the applicable country where such clinical trial takes place.
Phase I Trial means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;
Phase I Trial means, as to a specific pharmaceutical product, a controlled and lawful study in humans of the safety of a pharmaceutical product that is prospectively designed to generate sufficient data (if successful) to commence a Phase II Trial (or foreign equivalent) of such product, as further defined in United States Federal Regulation 21 C.F.R. §312.21 or the corresponding regulation in jurisdictions other than the United States.
Phase I Trial means a clinical trial of a Product with the endpoint of determining initial tolerance, safety, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.
Phase I Trial means the first phase of a clinical study involving the initial introduction of an investigational new drug into humans (generally, but not always, in the range of 20 to 30 subjects). Phase I studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness that provides data capable of meeting statutory standards for marketing approval. During Phase I, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase II Trials. For example, “Phase I Trial” includes a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(a) in the United States, or an equivalent or counterpart of the foregoing in any other country or jurisdiction. For clarity, “Phase I Trial” includes both Phase Ia and Phase Ib trials.