Sentences with phrase «investigational product»
An investigational product refers to a substance or device that is being studied and tested for its safety and effectiveness in medical research or clinical trials. It is not yet approved for general use and is undergoing investigation to evaluate its potential benefits and possible risks. Full definition
We also have a large - scale biologics manufacturing facility in Rensselaer, New York, where we produce commercial and investigational products for clinical trials, and a satellite office in Basking Ridge, New Jersey.
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Substantial enhancements to DuPont Nutrition & Health's (DuPont) probiotic production suite in Madison, Wisconsin, now enable greater efficiency with clinical investigational product and customer sample production.
Generated 48 country / 20 site - specific versions of informed consent forms; obtained 6 investigational product import licenses and 7 biological sample export licenses across 5 studies
• A Clinical Research Coordinator position with Care ID where I may use my skills in investigational products by ensuring protocol compliance at all times.
Liraglutide 3 mg is an investigational product and is not approved by the FDA.
We also have a large - scale biologics manufacturing facility in Rensselaer, New York, where we produce commercial and investigational products, and an office in Basking Ridge, New Jersey for some employees who work in our clinical development and biostatistics groups.
The purpose of this study is to assess whether the investigational product, AMG 232, can be given safely in combination with two different drugs to patients with metastatic melanoma: trametinib and dabrafenib or trametinib alone, and to know how AMG 232 is processed and excreted in men and women when combined with these drugs.
Permission to import and administer the investigational products in Mali was granted by the Republic of Mali Ministry of Health.
Ensured compliance by informing senior management of any process gaps with respect to FDA regulations, viz. changes in [company name] regulations and guidelines for marketed and investigational products, and recommended changes where applicable