Chapter 1 cont. Flashcards
type of drug name that is the molecular structure of the drug
chemical name
type of drug name that is given by the research and development investigators, consists of abbreviations or code numbers
code or laboratory name
type of drug name that is the USP legal name (United States Pharmacopeia)
Compendial or Offical name
type of drug name that is the same as the compendial name
official name
type of drug name that is the Protected name given by the manufacturer/innovator
proprietary or trade name
type of drug name that is the common name chosen by the company, not exclusive right of the company.
May be the same as the official or compendial name.
generic name
Which type of drug name is Capitalized
Proprietary or Trade name
Which type of drug name is lower case
compendial or common name
In general, be in the habit of referring to a drug by its
generic name
three reasons why generic drugs are cheaper
The innovator has significant costs in developing the drug
Safety and efficacy testing
Government regulations - very lengthy and expensive process to produce the Trade name drug
three government agencies involved with drug regulations
EPA
FDA
USDA
Five steps in developing a new drug
Preliminary trials
Preclinical trials
Clinical trials
Submission
Final review
how are preliminary trials done when developing a new drug
testing in a lab on simple organisms
how are preclinical trials done when developing a new drug
testing on lab animals - possibly a few of the target species
how are clinical trials done when developing a new drug
testing on target species
