N301 Q#1 Drug Regulation and Development

Question 1

the ______ of 1938 was the 1st legislation to regulate drug safety, all new drugs undergo ___ testing.

Answer 1

FD and Cosmetic Act

toxicity

Question 2

The Kefauver-Harris Amendments of 1962:

1. required proof of ____
2. older drugs had to undergo testing for effectiveness.
3. _____ procedures for testing new drugs

Answer 2

1. effectiveness

3. rigorous

Question 3

The controlled substance act established the ___ as the regulatory body responsible for the safe ____ and control of potentially ___ drugs.

Answer 3

DEA
distribution
addictive

Question 4

In 1997 the FDA ____ Act set up ___ tracking of drugs for serious and life threatening illnesses. Manufacturer’s must ___ patients _ months prior to d/c of a drug. Also allowed _____ use.

Answer 4

Modernization
inform
6
off-label

Question 5

The gold standard in pain medication is ____. to be approved, trial performed that showed new drug is at least as ___ as gold standard or the ___.

Answer 5

morphine
good
placebo

Question 6

the gold standard of antibiotics is ___.

Answer 6

penicillin

Question 7

Limitations of test procedures refers to limited information of many ____ prior to the 1990s. Due to a failure to detect all ___ effects.
During clinical trials, a relatively ___ number of patients are given the drug, ____ is not representative of pts that use the drug and pts use the drug for a relatively short time period.

Answer 7

populations
adverse
small
fully

Question 8

What are the stages of new drug development?

Answer 8

Preclinical (animal testing)

Clinical: phase 1, II, III, IV

Question 9

Describe clinical stages I, II, III and IV.

Answer 9

I: healthy volunteers evaluates drug metabolism & effects in humans
II and III: patients, evals therapeutic utility, dose range and effectiveness.
after III, the mfr applies to the FDA for a IND
IV: drug released for pt general use

Question 10

The chemical name is the exact chemical ____. The generic name is the _____ name.
The trade name is the ___ name that is approved by the FDA.

Answer 10

nomenclature
nonproprietary
proprietary

Question 11

For the chemical: opioid, the generic name is ___ while the trade name is ____.

Answer 11

oxycodone

oxycontin

Question 12

drugs that share similar characteristics are grouped together as a ______ group or family.

Answer 12

pharmacologic

Question 13

___ classification: describes chemical base

Answer 13

chemical

Question 14

____ classification: describes effect on body systems.

Answer 14

physiologic

Question 15

____ classification: describes use in therapy

Answer 15

therapeutic

Question 16

a drug can be of one chemical name but have various ____ and ___ functions

Answer 16

physiologic

therapeutic