Initiation of Phase I Clinical Trial definition

Initiation of Phase I Clinical Trial means the first visit by the first human patient in a Phase I Clinical Trial during which dosing of Product or placebo occurs.
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Initiation of Phase I Clinical Trial means the date of First Dosing in a Phase I Clinical Trial.
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Initiation of Phase I Clinical Trial means first administration of Licensed Product to a patient enrolled in the first human clinical trial for such Licensed Product for a certain disease(s), as applicable, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. §312.21(a).
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Examples of Initiation of Phase I Clinical Trial in a sentence

  • Initiation of Phase I Clinical Trial or Phase I/II Clinical Trial Six months after Approval of the IND by the FDA, provided, however, that if the FDA recommends in writing that additional non-clinical studies be performed prior to the initiation of the Phase I Clinical Trial or Phase I/II Clinical Trial, such target date shall be extended by the amount of the time needed to complete such studies plus an additional two (2) months.

Related to Initiation of Phase I Clinical Trial

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following: