1. Basic Pharmacology, and Drug Names and References Flashcards
Identifying drug names
Drug Nomenclature
Four terms apply to the various titles of a drug:
- Generic name
- Trade Name
- Chemical name
- Official name
common or general name assigned to the drug; differentiated from trade name by initial lowercase letter, never capitalized
Generic name
assigned to a drug usually based on the chemical name
Generic name
Non-proprietary name
Generic name
Related to Official Name
Generic name
usually enclosed in a box and in a larger font
Generic name
Brand name or Proprietary Name
Trade Name
The name which pharmaceutical company adapt
to their particular drug product
Trade Name
Copyrighted by and exclusive to the company
Trade Name
Usually have the ® (registered) or ™ (Trade Mark)
symbol on drug labels
Trade Name
can be distinguished from generic name by capitalized first letter
Trade Name
The exact molecular formula of the drug
Chemical Name
Usually, a very long name and difficult to
pronounce and of little concern to the health care worker
Chemical Name
The drug discovery process
- Drug Discovery (10,000-15,000 compounds)
- Drug Development and Pre-Clinical Research (250 compounds, 3-6 years)
- Clinical Trials (4 Phases) (5 compounds, 10-15 years)
- New Drug Application and Review and Approval (1 or 0 approved drug, 0.5-2 years)
- Post-Market Drug Safety Monitoring
- New insights into a disease process
- Molecular testing
- Advancing technology
- Unanticipated effects of existing treatments
Drug Discovery
Results obtained at this stage determine whether a drug will move into the clinical research phase
Drug Development and Pre-Clinical Research
participants (20-100)
Phase I Clinical Trials
__ of drugs move to Phase II
~70%
Several hundred participants
Phase II Clinical Trials
__ of drugs move to Phase III
~33%
participants (300-3000)
Phase III Clinical Trials
participants with the disease/condition __ of drugs move to Phase IV
~25-30%
Several thousands participants
Phase IV Clinical Trials
Once a drug has demonstrated satisfactory efficacy and safety, a _____ can be made to the local or regional approving body in accordance with applicable requirements
new drug marketing authorization application
In the months and years following a drug’s marketing authorization, _____ is continuously carries out to ensure a more detailed detailed drug safety profile
drug safety monitoring