Exploratory IND or Exploratory CTA Study definition
Exploratory IND or Exploratory CTA Study means a single exploratory first in human clinical study that (i) is completed primarily to obtain pharmacokinetic or pharmacodynamic information as is described in “Guidance for Industry, Investigators and Reviewers - Exploratory IND Studies,” dated January 2006, published by the FDA’s Center for Drug Evaluation and Research, and (ii) is not associated with a clinical development plan, and (iii) the sponsor of which specifically states in the IND that the IND is intended to be withdrawn after completion of the outlined study and the sponsor withdraws the IND following such study, and (iv) involves a limited number of subjects with a limited range of doses for a limited period of time, where such doses are intended to be sub-pharmacologic and for which there is no reasonable expectation that the dose could produce a toxic effect. In the event that FDA withdraws the guidance without replacing it with provisions that are in all material respects identical to the guidance, no Clinical Trial thereafter shall qualify as an “Exploratory IND or Exploratory CTA Study” hereunder.
Exploratory IND or Exploratory CTA Study means a single exploratory first in human clinical study that (i) is completed primarily to obtain pharmacokinetic or pharmacodynamic information as is described in “Guidance for Industry, Investigators and Reviewers—Exploratory IND Studies,” dated January 2006, published by the FDA’s Center for Drug Evaluation and Research, and (ii) is not associated with a clinical development plan, and (iii) the sponsor of which specifically states in the IND that the IND is intended to be withdrawn after completion of the outlined study and the sponsor withdraws the IND following such study, and (iv) involves a
Exploratory IND or Exploratory CTA Study means a single exploratory first in human Clinical Trial that (i) is completed primarily to obtain pharmacokinetic or pharmacodynamic information as is described in “Guidance for Industry, Investigators and Reviewers - Exploratory IND Studies,” dated January 2006, published by the FDA’s Center for Drug Evaluation and Research; (ii) is not associated with a clinical Research Plan; (iii) the sponsor of which specifically states in the IND that the IND is intended to be withdrawn after completion of the outlined study and the sponsor withdraws the IND following such study; and (iv) involves a limited number of subjects with a limited range of doses for a limited period of time, where such doses are intended to be sub-pharmacologic and for which there is no reasonable expectation that the dose could produce a toxic effect. In the event that FDA withdraws the guidance without replacing it with provisions that are in all material respects identical to the guidance, no Clinical Trial thereafter shall qualify as an “Exploratory IND or Exploratory CTA Study” hereunder.
More Definitions of Exploratory IND or Exploratory CTA Study
Exploratory IND or Exploratory CTA Study means a single exploratory first in human clinical study that (i) is completed primarily to obtain pharmacokinetic or pharmacodynamic information as is described in “Guidance for Industry, Investigators and Reviewers—Exploratory IND Studies,” dated January 2006, published by the FDA’s Center for Drug Evaluation and Research, and (ii) is not associated with a clinical development plan, and
Exploratory IND or Exploratory CTA Study means [*] In the event that FDA withdraws the Guidance without replacing it with provisions that are in all material respects the same as the Guidance, no clinical trial thereafter shall qualify as an “Exploratory IND or Exploratory CTA Study” hereunder. [*]
Exploratory IND or Exploratory CTA Study means [*] In the event that FDA withdraws the Guidance without replacing it with provisions that are in all material respects the same as the Guidance, no clinical trial thereafter shall qualify as an “Exploratory IND or Exploratory CTA Study” hereunder.