Phase I Clinical Trials definition

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 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 human clinical trials conducted to establish an initial safety profile and pharmacodynamics of Product in the particular indication tested.

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

• 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.

• Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials.

More Definitions of Phase I Clinical Trials

Phase I Clinical Trials means human clinical trials ------------- conducted in subjects to establish the safety profile of a Product.

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.

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 clinical studies in human beings performed in any country that are intended to initially evaluate the safety and/or pharmacological effect of a product in subjects or that would otherwise satisfy requirements of 21 CFR 312.21(a), or its foreign equivalent.