Drug Regulation

Question 1

The FDA regulates what _____ the manufacturer can place in the package insert and what ____ the manufacturer makes, but cannot regulate _____ by a physician.

Answer 1

indications for drug use; health claims; how a drug is actually used

Question 1

Name 2 drug categories that advise consistent use of either the brand or generic drug.

Answer 1

levothyroxine; anti-epileptic drugs

Question 2

The second phase of new drug testing is _____.

Answer 2

clinical trials in humans

Question 3

The bioequivalence variation of generics to the parent drug is ____.

Answer 3

less than 4%

Question 4

What is the first step in the evaluation of a new drug?

Answer 4

animal studies (rodents and non-rodents)

Question 5

After a phase III human clinical trial, the company can submit a ______ to the FDA for approval.

Answer 5

new drug application (NDA)

Question 6

A phase II human clinical trial test for _____, ____, ____, and ____ using _____.

Answer 6

safety, efficacy, dosing, toxicities; a select pt pool of 200-300 w/o prior medical problems

Question 7

A phase I clinical trial determines ____ and _____ using _____.

Answer 7

safety, pharmacokinetics; healthy male volunteers

Question 8

A ______ describes the effect a substance has on reducing the risk of or preventing a disease,

Answer 8

health claim

Question 8

Clinical trials in humans includes ___ phases.

Answer 8

3

Question 10

(are/aren’t) OTC drugs ____ evaluated, ____ prescription only, and _____ potentially abused.

Answer 10

are, are not, are not

Question 11

A ________ is defined as a product intended to supplement the diet that contains a vitamin, mineral, amino acid, or herb/botanical and is not represented as food.

Answer 11

dietary supplement

Question 12

The Food, Drug, and Cosmetic of 1938 (and Kefauver Amendments of 1962) requires that for new drugs and for drugs released since 1938 manufacturers must demonstrate ______ as well as _____ before they can be marketed to the public.

Answer 12

proof of efficacy; safety

Question 13

Low incidence drug effects will be missed in phases ___.

Answer 13

I-III

Question 14

The FDA requires that _____ must be met for generics.

Answer 14

bioequivalence standards

Question 15

A _____ is defined as a therapeutic agent intended to diagnose, treat, cure, or prevent a disease.

Answer 15

drug

Question 17

A ______ describes the role of a substance intended to maintain the structure or function of the body.

Answer 17

structure/function claim

Question 18

(are/aren’t) Dietary supplements ____ evaluated, ____ prescription only, and _____ potentially abused.

Answer 18

are not, are not, are not

Question 19

(are/aren’t) Controlled substances ____ evaluated, ____ prescription only, and _____ potentially abused.

Answer 19

are, are, are

Question 20

How many phases of drug testing are there?

Answer 20

5- 1 in animals, 4 in humans

Question 21

A health claim requires ______ prior to its use.

Answer 21

FDA evaluation and authorization

Question 22

(are/aren’t) Prescription drugs ____ evaluated, ____ prescription only, and _____ potentially abused.

Answer 22

are, are, are (but very low risk)

Question 23

It is assumed that bioequivalent drugs are _____, and proof is not required by the FDA.

Answer 23

therapeutically equivalent

Question 24

A phase III human clinical trial tests ____ and _____ using a ____ study and ______ participants.

Answer 24

efficacy, chronic use; double blind; 1000-6000

Question 25

“____” use for non-FDA approved indications is allowed as a physician sees fit.

Answer 25

Off-label

Question 26

A ______ requires FDA evaluation and authorization prior to its use.

Answer 26

health claim

Question 27

Preclinical testing/animal studies include ____ and _____.

Answer 27

attempts to determine a safe dosage range, an IND application