U4.2: DRG DEVELOPMENT & REGULATION

Question 1

4 components of Drug Discovery

Answer 1

1. Chemical modification
2. Random screening of the biological products
3. Rational drug design
4. Biotechnology and cloning using gene

Question 2

3 components of Drug Screening

Answer 2

1. Biologic products
2. Chemical synthesis
3. Lead compound

Question 3

The amount of animal testing required before human studies begin is a function of the propsoed use and the urgency of the application

Answer 3

Preclinical Safety & Testing

Question 4

Preclinical Safety & Testing

Administration of single dose to the lethal doses in at least 2 species

Answer 4

Acute Toxicity

Question 5

Preclinical Safety & Testing

manifests about 2 to 4 weeks

Answer 5

Subacute Toxicity

Question 6

Preclinical Safety & Testing

Test wherein it will be conducted between 6 to 24 months exposure to the drug

Answer 6

Chronic Toxicity

Question 7

Preclinical Safety & Testing

2 and 3 tests are conducted for at least the length of time proposed for human

Answer 7

Chronic Toxicity

Question 8

Preclinical Safety & Testing

Induction of developmental defects in somatic tissues of the fetus

Answer 8

Teratogenicity

Question 9

Preclinical Safety & Testing

Induction of changes in the genetic material of animals of any age inducing heritable abnormalities

Answer 9

Mutagenicity

Question 10

Mutagenicity

Standard in vitro test for mutagenicity

Answer 10

Ames Test

Question 11

Mutagenicity

Uses a special strain of salmonella bacteria that naturally depends on specific nutrients in the culture medium

Answer 11

Ames Test

Question 12

Mutagenicity

Loss of this dependence during exposure to the test drug signals mutation

Answer 12

Ames Test

Question 13

Evaluation in Humans

Usually last for 4 to 6 years before completion and approval

Answer 13

Clinical Trials

Question 14

T/F Clinical trials are natural variable history of the disease

Answer 14

T

Question 15

T/F Clinical trials use a cross-over design

Answer 15

T

Question 16

T/F Clinical trials two groups is given the standard

Answer 16

F; 2 groups of patient, 1 group given the standard

Question 17

T/F Presence of other disease and risk factors should be considered with clinical trials

Answer 17

T

Question 18

T/F You have to critically select the patients that conduct clinical trials

Answer 18

T

Question 19

Clinical Trials

Careful evaluation of the dose-response relationship in a small number of normal human volunteers (20 to 30)

Answer 19

Phase I

Question 20

Clinical Trials

Except for trials of chemotherapeutic drugs and other highly toxic drugs carried by administering to patients with target disease

Answer 20

Phase I

Question 21

Clinical Trials

Evaluation of a drug in a moderate number of patients (100 to 300) with the target disease

Answer 21

Phase 2

Question 22

Clinical Trials

Placebo or posiitve control is included in a single-blind or double-blind study

Answer 22

Phase 2

Question 23

Clinical Trials

Carefully controlled conditions and very closely monitored

Answer 23

Phase 2

Question 24

Clinical Trials

Determines if the drug has the therapeutic effects

Answer 24

Phase 2

Question 25

Clinical Trials

Large design involving many patients (1,000 to 5,000) or more in many centers and many clinicians who are using the drug in the manner proposed for its general use

Answer 25

Phase 3

Question 26

Clinical Trials

Placebo, double-blind crossover trial

Answer 26

Phase 3

Question 27

Clinical Trials

Explore the spectrum of beneficial actions of the new drug, compare with older/ standard therapies

Answer 27

Phase 3

Question 28

Clinical Trials

Discover toxicities

Answer 28

Phase 3

Question 29

Clinical Trials

Toxicities that occur very infrequently will be detected and reported early enough to prevent major therapeutic disasters

Answer 29

Phase 4

Question 30

Clinical Trials

Postmarketing surveillance

Answer 30

Phase 4

Question 31

Clinical Trials

Not rigidly regulated by the Bureau of Food and Drugs
(BFAD)

Answer 31

Phase 4