V - Drug Regulation

Question 1

Required before human studies begin

Answer 1

Animal Testing

Question 2

Demonstrates the function of the proposed use and the urgency of the application

Answer 2

Animal Testing

Question 3

Required for all new drugs

Answer 3

Acute Toxicity

Question 4

Involve administration of single doses of the agent up to the lethal level in at least 2 species

Answer 4

Acute Toxicity

Question 5

Required for most agents especially those intended for chronic use, tested in at least 2 species

Answer 5

Subacute and Chronic Toxicity

Question 6

Duration: Subacute Toxicity

Answer 6

2-4 weeks

Question 7

Duration: Chronic Toxicity

Answer 7

6-24 months

Question 8

Description of all the pharmacologic effects of a drug

Answer 8

Pharmacologic Profile

Question 9

Pharmacologic profiles require _____ data.

Answer 9

graded and quantal dose-response

Question 10

Involves the study of the fertility effects of the candidate drug and its teratogenic and mutagenic toxicity

Answer 10

Reproductive Toxicity

Question 11

FDA Drug Categories: fail to demonstrate a risk to human fetus in the first trimester, no evidence of risk in later trimesters, possibility of harm is remote

Answer 11

A

Question 12

FDA Drug Categories: animal studies have not demonstrated fetal risk and no controlled human studies, animal studies showed adverse effect not confirmed in humans

Answer 12

B

Question 13

FDA Drug Categories: adverse effect in animal fetus and no controlled human studies, studies in humans and animals are not available

Answer 13

C

Question 14

FDA Drug Categories: positive evidence of human and animal fetal risk, some benefits

Answer 14

D

Question 15

FDA Drug Categories: fetal abnormalities and risk, risk outweighs benefit

Answer 15

X

Question 16

Induction of developmental defects in the somatic tissues of the fetus

Answer 16

Teratogenesis

Question 17

Teratogenesis is studied by

Answer 17

treating pregnant female animals of at least 2 species at selected times during early pregnancy when organogenesis takes place

Question 18

Teratogens: ACE Inhibitors

Answer 18

fetal renal damage

Question 19

Teratogens: Anti-epileptic Drugs

Answer 19

neural tube defects

Question 20

Teratogens: Phenytoin

Answer 20

fetal hydantoin syndrome

Question 21

Teratogens: Oral Hypoglycemic agents

Answer 21

neonatal hypoglycemia

Question 22

Teratogens: Barbiturates

Answer 22

neonatal dependence

Question 23

Teratogens: Diethylstilbestrol (DES)

Answer 23

vaginal clear cell adenoCA

Question 24

Teratogens: Ethanol

Answer 24

fetal alcohol syndrome

Question 25

Teratogens: Lithium

Answer 25

Ebstein's anomaly

Question 26

Teratogens: Isotretinoin

Answer 26

craniofacial malformations

Question 27

Teratogens: Iodide

Answer 27

congenital hypothyroidism

Question 28

Teratogens: Misoprostol

Answer 28

Mobius sequence

Question 29

Teratogens: Penicillamine

Answer 29

cutis laxa

Question 30

Teratogens: Thalidomide

Answer 30

phocomelia

Question 31

Teratogens: Smoking

Answer 31

IUGR

Question 32

Teratogens: Tetracycline

Answer 32

tooth discoloration

Question 33

Teratogens: Streptomycin

Answer 33

ototoxicity

Question 34

Teratogens: Methimazole

Answer 34

aplasia cutis congenita

Question 35

Teratogens: Sulfonamides

Answer 35

kernicterus

Question 36

Teratogens: Fluoroquinolones

Answer 36

cartilage damage

Question 37

Teratogens: Warfarin in the 1st Trimester

Answer 37

chondrodysplasia

Question 38

Teratogens: Warfarin in the 2nd Trimester

Answer 38

CNS malformations

Question 39

Teratogens: Warfarin in the 3rd Trimester

Answer 39

bleeding diatheses

Question 40

Induction of changes in the genetic material of animals of any age and therefore induction of heritable abnormalities

Answer 40

Mutagenesis

Question 41

Standard in vitro test for mutagenicity

Answer 41

Ames Test

Question 42

Uses a special strain of Salmonella that naturally depends on specific nutrients, loss of this dependence signals a mutation

Answer 42

Ames Test

Question 43

In vivo mutagenicity test carried out in mice

Answer 43

Dominant Lethal Test

Question 44

Male animals are exposed to the test substance before mating, abnormalities in the results of subsequent mating signal a mutation in the male's germ cells

Answer 44

Dominant Lethal Test

Question 45

Induction of malignant characteristics in cells and expensive to study, high degree of correlation with mutagenicity in Ames Test

Answer 45

Carcinogenesis

Question 46

Requires approval by institutional committees that monitor the ethical and scientific aspects of the proposed test

Answer 46

Clinical Trial

Question 47

Includes all pre-clinical data collected up to the time of submission and the detailed proposal for clinical trials

Answer 47

Investigational New Drug

Question 48

Constitutes the request for approval of general marketing of the new agent for prescription use and includes all the results of pre-clinical and clinical testing

Answer 48

New Drug Application

Question 49

Clinical Trial Phases: careful evaluation of the dose-response relationship and pharmacokinetics among normal human volunteers (25-50), acute effects of the agent are studied over a broad range of dosages

Answer 49

Phase I Trial

Question 50

Clinical Trial Phases: Is it safe?

Answer 50

Phase 1 Trial

Question 51

Clinical Trial Phases: evaluation of a drug in a moderate number of patients with the target disease (100-300), placebo and control (single/double blind), controlled conditions and close monitoring (hospital ward), tests if desired efficacy is achieved and if drug istolerated by sick patients

Answer 51

Phase 2 Trial

Question 52

Clinical Trial Phases: Is it effective?

Answer 52

Phase 2 Trial

Question 53

Clinical Trial Phases: large design involving many patients (1000-5000) and many clinicians, placebo and control (double-blind/crossover), explores the spectrum of beneficial actions, compares new drug to old treatment, discovers toxicities, large amount of data, very expensive

Answer 53

Phase 3 Trial

Question 54

Clinical Trial Phases: post-marketing surveillance phase, detects toxicites that occur infrequently, findings reported early enough to prevent major therapeutic disasters

Answer 54

Phase 4 Trial

Question 55

Submitted when a new drug enters animal testing, right to market the drug without competition from other firms for a period of 20 years, after expiration, any company may apply to the FDA for permission to market a generic version of the same drug

Answer 55

Drug Patent

Question 56

A new version of a patented drug must be

Answer 56

bioequivalent

Question 57

Two related drugs are _____ if they show comparable bioavailability and similar times to achieve peak blood concentrations.

Answer 57

bioequivalent

Question 58

Used in determining safety and efficacy of generic drugs

Answer 58

Bioequivalence

Question 59

Drug for a rare disease (< 20,000 people)

Answer 59

Orpan Drug