What is a drug?
What is a drug (per FDA definition)?
This substance is intended to diagnose, treat, cure, prevent disease, or affect body structure or function.
What is the FDA?
Food and Drug Administration that approves, monitors drugs after approval, pull drugs if unsafe, and track side effects via Medwatch.
What is the Pure Food and Drug Act (1906)?
What is bioequivalence?
describes two drugs that have the same rate and extent of absorption.
What is the Pre-clinical phase?
animal testing for toxicity and pharmokinetics during this phase.
What is a drug?
A pill taken to lower blood pressure would be classified as this under FDA rules.
What is post-marketing safety monitoring?
The FDA's responsibility to continue to monitor drugs after it is released to the public.
What is Food, Drug and Cosmetic Act (1938)?
a law that required drug manufacturers to prove safety before marketing. (FDA can inspect factories)
What is that the drugs are bioequivalent?
matching Cmax, Tmax, AUC between two drugs supports this conclusion.
What is Phase 1?
Small group of healthy volunteers (20-80) is used to assess safety, side effects, and dosing.
What is a dietary supplement?
excluded from the FDA drug definition. considered a food and can't claim to diagnose, treat, prevent, or cure a disease.
What is Medwatch?
An FDA system that allows clinicians and consumers to report adverse drug events.
What is Kefauver - Harris Amendments (1962)?
an amendment that required proof of both safety and efficacy of drugs. side effects must be disclosed on ads.
What is an ANDA (Abbreviated New Drug Application)?
an FDA application allowing generics to be approved without repeating clinical trials.
What is Phase 2?
group of individuals with disease are used to assess drug efficiency, dose-response. This has the highest failure rate.
What are biologics?
made from living sources (vaccines, insulin, monoclonal antibodies)
What is Medwatch requested information?
patient demographics, problem, product or device, any concomitant problems, reporter information.
What is FDA amendments Act (2007)?
This required postmarketing studies.
What is a generic drug?
type of drug must match the brand-name product in strength, dosage, form, route and clinical effect.
What is Phase 3?
Large patient group with the disease (1,000-5,000) compare the drug to placebo before NDA submission.
What is Phase 4?
post-marketing. drug is released to the market and FDA keeps monitoring. rare side effects show up here.