Clinical Study definition
Clinical Study means a clinical study (including a Post-Marketing Study or Phase IV Clinical Study) in humans the purpose of which is to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product, as applicable.
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Clinical Study or “Clinical Studies” means a Phase ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.
Examples of Clinical Study in a sentence
As soon as reasonably practicable after the Effective Date but at least six (6) months prior to the First Commercial Sale or the initiation of any Clinical Study relating to the Product by ▇▇.
More Definitions of Clinical Study
Clinical Study means a Phase I Study, Phase II Study (including a Phase II(a) and Phase II(b) Study), Phase III Study or Post-Approval Studies, as applicable.
Clinical Study means a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.
Clinical Study means any human clinical trial of a Product Candidate.
Clinical Study means a study in which human subjects or patients are dosed with a drug, whether approved or investigational.
Clinical Study means any investigation in relation to humans intended:
Clinical Study means the investigation as defined in the cadre above, (also) to be conducted at the Study Site in accordance with the Protocol;
Clinical Study means, with respect to a Product, a clinical study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of a marketing application for such Product.