FDADrugDevFC Flashcards
What is CDER?
The Center for Drug Evaliation and Research is the part of FDA that oversees the drug approval process.
How does the drug approval process begin?
Pre-clinical (animal) research which is followed by an IND application.
What is an IND application?
It is an Investigational New Drug application required by FDA.
Why is an IND needed?
Federal laws requires that application in place before a drug is transported or distributed across states lines.
Why is it important to the manufacturers to have an IND issued?
In order to be able to ship the investigational drug to clinical investigators in many states, the manufacturers need an exempt from that requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.
What is the focus of the phase I in the clinical trial process?
Safety profile and dosing range. Pharmacology of compound.
How does the phase I in the clinical trial process is conducted?
Low doses of the compound are given to a small group (20-80 subjects) of healthy volunteers who are closely supervised. In cases of severe or life-threatening illness, volunteers with the disease may be used.
What is the focus of the phase II in the clinical trial process?
Effectiveness of a compound (dose response).
How does the phase II in the clinical trial process is conducted?
To avoid unnecessarily exposing a human volunteer to a potentially harmful substance, studies are based on an analysis of the fewest volunteers needed to provide sufficient statistical power to determine efficacy. Used in intended population only.
What is the purpose of the phase III in the clinical trial process?
Test safety and efficacy at the dose and schedule you are seeking approval (package labeling). During this phase, researches try to confirm previous findings in a larger population.
How does the phase III in the clinical trial process is conducted?
These studies are tested in subjects with indication only and usually involve thousands of patients across multiple sites.
What happens after Phase III?
The manufacturer files a New Drug Application (NDA) that can be either approved or rejected. In the case of rejection, the FDA might request further study before making a decision.
What is a post-marketing study?
It’s the phase IV that examines the risks and benefits of the new drug in a different population or to conduct special monitoring in a high-risk population.
What is the purpose of the Phase IV in a clinical trial?
It can be used to asses such issues as the longer term effects of drug exposure, to optimize the dose for marketing, to evaluate the effect in pediatric patients or to examine the effectiveness of the drug for additional indications.
What application is required by FDA to request approval of a generic drug?
Abbreviated New Drug Application (ANDA).
