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Τι (ποιος) είναι investigational new drug - ορισμός
Investigational New Drug
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at .
Experimental drug
MEDICINAL PRODUCT NOT YET APPROVED FOR ROUTINE USE
Experimental medicine; Experimental treatment; Investigational medication; Experimental medication
An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions.
Drug interaction
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CHANGE IN THE ACTION OR SIDE EFFECTS OF A DRUG CAUSED BY ANOTHER DRUG
Drug-drug interaction; Drug interactions; Herb-drug interactions; Drug-plant interactions; Pharmacokinetic interactions; Adverse interaction; Drug–drug interaction; Pharmacodynamic drug interaction; Pharmacodynamic drug interactions; Pharmacokinetic drug interaction; Pharmacokinetic drug interactions; Pharmacokinetic interaction; Pharmacodynamic interactions; Pharmacodynamic interaction
Drug interactions occur when a drug's mechanism of action is disturbed by the concomitant administration of substances such as foods, beverages, or other drugs. The cause is often the inhibition of the specific receptors available to the drug, forcing the drug molecules to bind to other non-intended targets which results in an array of side-effects.
Παραδείγματα από το σώμα κειμένου για investigational new drug
1. The company said it has filed a Pre–Investigational New Drug Application with the Paul Ehrlich Institute in Germany for its product PLX–PAD.
2. Food and Drug Administration recently approved the firm‘s investigational new drug application, enabling Can–Fite to move forward with phase I human clinical trials, which are being conducted in the U.S. by a clinical research organization.