Chapter 4 – NAPSRX Exam Study Guide.
Biology, Physiology, Clinical Pharmacology - answer3 areas a rep must have a solid understanding of in
order to sell effectively
Anatomy - answerStudy of the basic structures of the body
Physiology - answerStudy of HOW basic body structures function
Clini...
Areas a patent covers for a drug - answer✔the drug itself
The way the drug is made
The way a drug is to be used
method of delivering the drug
Name, size, shape and color - answer✔Legally, the ways a generic drug must vary from its trade name
counterpart
20% - answer✔The legal amount a drug can vary in bioequivalence from its trade
3-4% - answer✔The amount a generic usually varies in bioequivalence
Preclinical testing - answer✔Gathers info about how a drug works, how effective it is and what toxic
effects it causes
5 of 4,000 - answer✔The number of drugs that are actually studied in people
1 of 5 - answer✔Drugs studied in people that are approved by FDA
Safety and efficacy - answer✔2 main goals of drug development
Margin of safety - answer✔the difference between the usual effective dose and the dose that induces
severe side effects
3 - answer✔# of names each drug has
trade name
chemical name
generic name - answer✔3 types of names each drug has
United States Adopted Name Council (USANC) - answer✔Assigns the generic name for a drug
Chemical name - answer✔the name that describes the atomic and molecular structure of the drug
By therapeutic group - answer✔Broadly, how drugs are classified
Federal Food & Drug Consumer Act - answer✔FFDCA
Drug (FFDCA) - answer✔Any substance intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease
-A substance other than food intended to affect the function of the body
Drugs, Biologics, Alternative medicine - answer✔3 general categories that substances applied for
therapeutic purposes fall in to
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