Drug Development Regulation
What is the Kefauver-Harris Drug Amendment?
Occurring when specific patients are preferentially enrolled into one treatment group over another, this type of bias can be overcome with the use of randomization in your study design.
What is selection bias?
The first studies to test a drug in humans, these typically include 20-50 healthy volunteers with the goal to determine safety and toxicity.
What are Phase I studies?
Prospective or retrospective, this type of study design is susceptible to confounding variables but can be used to establish an association between an exposure and an outcome.
What is a cohort study?
Known for the phrase 'Be Kind, Rewind', this establishment allowed you to rent tapes/DVDs before streaming became the standard for watching movies.
What is Blockbuster?
Enacted in response to the sulfanilamide disaster, this act required products demonstrate safety before being marketed.
What is the Food, Drug, and Cosmetic Act of 1938?
This design feature is used when study treatment and comparator cannot be made to appear similar; subjects will receive both study drug and placebo to maintain blinding.
What is double dummy?
Submitted by the sponsor after conducting clinical trials, this document 'tells the drug's whole story to the FDA'.
What is a New Drug Application (NDA)?
Prone to recall bias, this survey-based study design is limited to assessing transient effects.
What is a cross-sectional study?
What is Wednesday?
This act required manufacturers to include dangerous chemicals, such as alcohol, on the list of ingredients in drug and food products.
What is the Pure Food and Drugs Act of 1906?
Used when superiority of the test drug is not expected, this type of study design seeks to establish that one intervention is no worse than another intervention.
What is a non-inferiority study?
Used by drugs undergoing accelerated approval, this measurable endpoint is used as a substitute for a clinical outcome of interest.
What is a surrogate endpoint?
Limited to the description of one patient, this type of publication cannot determine cause and effect relationships but can be used to describe off-label use of a medication.
What is a case report?
Forget Spotify! This is the price you would pay to purchase a song from the iTunes store.
What is $0.99?
This was the first federal law to regulate drugs and required the US Customs Service to inspect imported medications for purity and strength.
What is the Import Drug Act of 1848?
Identified a priori, this threshold signifies the extent to which the test drug can be worse than the control drug and still be considered non-inferior.
What is the non-inferiority margin?
Unlike the Right to Try Act, use of a medication through Expanded Access requires the requestor to obtain authorization from these groups.
What is FDA and IRB authorization?
Calculated in case-control studies, this is a ratio of the probabilities of an outcome being associated with the exposed (case) vs the unexposed (control).
What is an odds ratio?
This song served as the theme song to the hit reality TV show, The Hills.
What is 'Unwritten' by Natasha Bedingfield?