Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.
Clinical Trials means trials that: 1) have been subjected to independent peer-review of the rationale and methodology; 2) are sponsored by an entity with a recognized program in clinical research that conducts its activities according to all appropriate federal and state regulations and generally accepted standard operating procedures governing the conduct of participating investigators; and 3) the results of which will be reported upon completion of the trial regardless of their positive or negative nature.
Clinical Trials means Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials or Phase IV Clinical Trials.
Examples of Clinical Trials in a sentence
Clinical Trials This plan covers clinical trials as required under R.I. General Law § 27-20-60.
In Clinical Trials: Persons with genotype 1a who did not have cirrhosis were treated with Viekira Pak® and ribavirin for 12 weeks and had a 96% response (cure) rate.
More Definitions of Clinical Trials
Clinical Trials means all Phase I/II Clinical Trials, Phase II Clinical Trials and Phase III Clinical Trials, or such analogous studies and trials of a medical device as are intended to establish scientifically valid evidence to be submitted in an application to a Regulatory Authority for the Product.
Clinical Trials means human studies designed to measure the safety and/or efficacy of the Product. Clinical Studies include Phase I Clinical Trials, Phase II Clinical Trials, and Phase III Clinical Trials.
Clinical Trials means Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Phase 4 Trials, and/or variations of such trials (for example, Phase 3/4).
Clinical Trials means a Phase II Clinical Trial or a Phase III Clinical Trial.
Clinical Trials means any and all human clinical trial of a compound, including without limitation Phase 1 Clinical Trials, Phase 2 Clinical Trials, Phase 3 Clinical Trials, Phase 4 Clinical Trials, bioequivalence trials, and/or variations of such trials (for example, phase 2/3 studies).
Clinical Trials means any administration of Licensed Products to humans for the purpose of demonstrating the safety or efficacy of the Licensed Product.
Clinical Trials means any investigation in human subjects intended to discover or verify the clinical, pharmacological , and/or other pharmacodynamic effects of Licensed Product, and/or to identify any adverse reactions to Licensed Product, and/or to study absorption, distribution, metabolism, and excretion of Licensed Drug Product with the object of ascertaining its safety and/or efficacy for purposes of obtaining regulatory approval to commercialize and market the Licensed Drug Product.