Phase I Clinical Trials definition

Phase I Clinical Trials means initial studies of the administration of therapy utilizing the Product in humans, using a limited number of healthy volunteer subjects for the purpose of obtaining pharmacology data, safety and other information concerning the Product.

Phase I Clinical Trials means the initial trials in the Territory on a limited number of normal volunteers or patients that are designed to establish that a drug is safe for its intended use and to support its continued testing in Phase II Clinical Trials.

Phase I Clinical Trials means any human clinical trials, the principal purpose of which is a preliminary determination of safety of a Licensed Product for its intended use in healthy individuals or patients to support its continued testing in similar clinical trial prescribed by the relevant Regulatory Authorities.

Examples of Phase I Clinical Trials in a sentence

• The new guidelines Previous guidelines in this area have been replaced in order to reflect the agreed ABPI position: the 1988 Non-Patient Guidelines are now replaced by the compensation provisions set out in the Phase I Clinical Trials Compensation Guidelines; and the 1991 Clinical Trial Guidelines are now replaced by the compensation provisions set out in the Phases II, III and IV Clinical Trials Compensation Guidelines.

• Consequential changes to the relevant section on compensation in the ABPI’s Guidelines For Phase I Clinical Trials (2012 Edition) have also been made.

• Legedza, ATR, Ibrahim, JG, “Heterogeneity in Phase I Clinical Trials: Prior Elicitation and Computation Using the Continual Reassessment Method,” Statistics in Medicine, 2001; 20:867–882.

• Legedza, ATR, and Ibrahim, JG “Longitudinal Design for Phase I Clinical Trials Using the Continual Reassessment Method,” Controlled Clinical Trials, 2000; 21:574–588.

• Details of such procedures shall be agreed upon by the Parties prior to the initiation of Phase I Clinical Trials by or on behalf of MITSUBISHI.

More Definitions of Phase I Clinical Trials

Phase I Clinical Trials means investigational use of a Licensed Product for determining metabolic and pharmacologic actions in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, under 21 C.F.R. Part 312 or comparable laws, rules, or regulations of another Regulatory Authority.

Phase I Clinical Trials means small scale human clinical trials conducted in normal volunteers and designed to evaluate the safety of the Product.

Phase I Clinical Trials means first clinical trial where the Product is applied in healthy human volunteers to test safety of such Product.

Phase I Clinical Trials means clinical trials in healthy adults and/or in a small number of patients commencing upon the filing of a trial protocol with the appropriate regulatory body and designed to determine the metabolism and pharmacologic actions of a product in humans, the side effects associated with increasing doses and to gather evidence on effectiveness and meeting the requirements established by the FDA or by the equivalent Japanese agency for Phase I clinical trials. The completion of the Phase I Clinical Trials will be deemed to have occurred upon the first formal internal issuance of trial results as measured by trial objectives, or in any event no later than the commencement of the Phase II Clinical Trials.

Phase I Clinical Trials means the initial clinical trials conducted in humans to establish the safety profile of a Drug Product candidate and to collect initial data on its pharmacokinetics and pharmacological effects.

Phase I Clinical Trials means those clinical trials as defined in 21 C.F.R. 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the U.S.

Phase I Clinical Trials means the initial portion of the clinical development that provides for the continued trials of pharmaceutical product on sufficient numbers of patients to establish safety and tolerability.