Study Set Content:
Other concomitant treatments are excluded (usually)
Pre-marketing clinical trials
Used the outcome of interest
Post-marketing monitoring
Used of surrogates markers instead of the outcome of interest (e.g. blood pressure or lipid levels to establish potentially fatal outcome such as heart attack)
Pre-marketing clinical trials
random and global scale
Post-marketing monitoring
Strict inclusion/exclusion criteri
Pre-marketing
Controlled environment
Pre-marketing
Known denominator for patients exposure (so we could establish the incidence of adverse events)
Pre-marketing
Low frequency reactions (not identified in clinical trials)
Post-marketing
High risk groups
Post-marketing
Long-term effects • Drug-drug/food interactions
Post-marketing
Data collected on standardized form • Follow-up information is generally accessible
Pre-marketing
Increased severity and / or reporting frequency of known reactions
Post-marketing
Follow-up information is generally accessible
Pre-marketing
All reports are medically confirmed
Pre-marketing
The data collected in clinical trials is clean and reproducible
Pre-marketing
An application that drug companies must file in order to request regulatory approval for new drugs from the FDA. • Must include detailed evidence from a series of clinical trials, each of which involves escalating standards of scientific evidence.
New Drug Application (NDA
t is extremely () to develop a drug to the point where an NDA can be filed.
difficult
A pathway designed for the approval of generic drugs
Abbreviated New Drug Application
Unlike an NDA, which is used for new, innovative drugs, an ANDA does not require the submission of() data to establish safety and efficacy
preclinical and clinical
_________ drugs are required to be _____________ to an already approved brand-name drug. This means that it must contain the same active ingredients, in the same strength and dosage form, and must deliver the same therapeutic effec
Generic, bioquivalence
