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 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.
Examples of Clinical Study in a sentence
In addition, with respect to Products, AstraZeneca will provide Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports.
In addition, with respect to Products, AstraZeneca will provide Isis with copies of Annual safety updates filed with each IND and the safety sections of any final Clinical Study reports within 30 days following the date such information is filed or is available to AstraZeneca, as applicable.
More Definitions of Clinical Study
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.
Clinical Study means a 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 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 any and all tests and studies in human subjects that are required by Applicable Law, or otherwise requested or recommended by the Regulatory Authorities, to obtain, maintain or expand Regulatory Approvals for a Collaboration Product for an Indication, including Post-Approval Commitments, safety / efficacy studies, and pharmacoeconomic studies or Marketing Studies.
Clinical Study means a human clinical trial for the Licensed Asset or a Product and any other tests and studies for the Licensed Asset or a Product in human subjects.