Ch 2 Review

Question 1

Drug Approval Process:

It can take 2-10 years but a pharmaceutical company must discover and identify a compound

Answer 1

Identifying Drug Compound

Question 2

Drug Approval Process:

Tested on animals to determine if drug is safe for human use and potential pharmacologic use

Answer 2

Preclinical testing

Question 3

Drug Approval Process:
Pharmaceutical company must file an investigational drug application with FDA. After IND is approved, compound becomes an investigational drug and can be tested in humans, which requires special recordkeeping and dispensing procedures.

Answer 3

Investigational Drugs

Question 4

Drug Approval Process:
A small number of healthy volunteers (20-80) are given small doses of investigational drug to determine safety and to helps determine the drug’s therapeutic dose

Answer 4

Phase I Clinical Trial

Question 5

Drug Approval Process:
100-300 patients (with disease the investigational drug is intended to treat) are given the drug to determine the effectiveness (efficacy), dose, dosing intervals, and method of drug delivery

Answer 5

Phase II Clinical Trial

Question 6

Drug Approval Process:
A large number of patients (1000-5000) are given the drug to determine safety and efficacy, including drug’s benefit vs. risk ratio, side effects, drug interactions, and use in special populations.

Answer 6

Phase III Clinical Trial

Question 7

NDA

Answer 7

New Drug Application

Question 8

IND

Answer 8

Investigational Drug

Question 9

Drug Approval Process:
After clinical trials, the pharmaceutical company must file a NDA with the FDA. If approved (which could take months to several years), compound can come to market

Answer 9

New Drug

Question 10

Drug Approval Process:
The post-marketing testing period, where drug is monitored for safety and any serious or unexpected adverse reactions are required to be reported to the FDA.

Answer 10

Phase IV Testing