| investigational new drug |
a drug allowed by the US Food and Drug Administration (FDA) to be used in clinical trials, but not approved for sale to the general public.
출처: www.luhs.org/health/topics/glossary/i.htm
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|---|---|
| investigational new drug |
The pre-approval status of an experimental drug or biologic (eg vaccine) after the US Food and Drug Administration (FDA) agrees that it can be tested in people (generally done in order to collect sufficiently data for licensure.) "IND" often refers to the application to obtain this pre-approval status.
출처: www.sabin.org/vaccine_science_GlossaryH_K.htm
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| investigational new drug |
Following clearance of an Investigational (preclinical) New Drug submission (IND), manufacturers may be authorized to supply a new drug to a qualified investigator(s) specifically for the purpose of conducting clinical evaluations to obtain data about the safety and efficacy of that drug. Information required for a preclinical new drug submission is outlined in section C.08.005 of the Food and Drug Regulations.
출처: www.hc-sc.gc.ca/vetdrugs-medsvet/glossary_of_terms...
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| investigational new drug |
The status of an experimental drug after the Food and Drug Administration agrees that it can be tested in people.
출처: www.aidsinfobbs.org/letters/i.html
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| investigational new drug |
An experimental drug tested in a clinical trial.
출처: www.mayoclinic.com/invoke.cfm
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