CLINICAL TRIALS
This phase focuses on evaluating effectiveness in target patients.
What are phase II clinical trials?
This includes Discovery, Preclinical Research, Clinical Trials, and Post-Market Surveillance.
What are the main stages of drug development?
This is considered the originator of the opioid crisis in the U.S.
What is OxyContin?
THIS FDA LEGISLATION established the generic drug approval process.
What is the Hatch-Waxman Act of 1984?
Filing a patent at this stage of clinical trials helps to defend against other competitors who might be first to market.
What is phase I filing of patents?
This confirms efficacy and monitoring side effects in large populations.
What are phase III clinical trials?
This type of research involves laboratory and animal testing for safety and efficacy.
What is preclinical research?
This drug contains both Amphetamine and dextroamphetamine.
What is Adderall?
FDA legislation allowed the collection of fees from companies to speed drug reviews.
What is the Prescription Drug User Fee Act (PDUFA) of 1992?
Filing a patent at this stage of clinical trials allows for a greater effective patent life, but may make a drug company vulnerable to competitors.
What is phase III filing of a drug patent?
Type of clinical research that studies events as they occur moving forward.
What is prospective evaluation/clinical research?
Includes absorption, Distribution, Metabolism, and Excretion analysis.
What are ADME studies?
This drug caused severe birth defects (phocomelia) and was originally used for morning sickness in pregnant women.
What is Thalidomide?
This FDA legislation streamlined drug approvals and supported patient access to experimental drugs.
What is the FDA Modernization Act of 1997?
This term refers to what happens to a biopharmaceutical when their patent expires and their revenue drops by 80-90%.
What is a patent cliff?
Involves a type of bias that has unequal selection of participants affecting results.
What is selection bias?
Includes Phase I (safety), Phase II (efficacy), Phase III (confirmation), Phase IV (post-market).
What are the four clinical trial phases?
This was developed by a scientist who refused to patent it because he stated "would you patent the sun"?
What is the polio vaccine?
THIS FDA LEGISLATION created an approval pathway for biosimilars.
What was the purpose of the Biologics Price Competition and Innovation Act (2009)?
This is when generic drugs are able to enter the market and compete with the brand name drug.
What is post-patent expiration?
A type of bias in clinical trials which favors results that support pre-existing beliefs.
What is confirmation bias?
Testing in healthy volunteers for safety and dosage.
What are Phase I of clinical trials?
Has no generics on the market because biopharmaceutical companies have managed to deter generic drug competitors.
What is insulin?
What are the Centers for Biologics Evaluation and Research and Drug Evaluation and Research?
This is the reason that insulin prices remain controversial, have limited competition, and have high prices in some places.
What are patent extensions?