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Flashcards in Drug Evaluation and Regulation Deck (29):
1

Which of the following is/are true about animal testing?
A. Animal testing is required before human studies begin.
B. Drug proposed for nonsystemic use requires less extensive testing.
C. Anti-cancer drugs and drugs proposed for use requires in AIDS require less evidence of safety.

All are true.

2

Which of the following is/are true about testing of acute toxicity?
A. It is required for all new drugs.
B. It involves administration of single doses of the agent up to the lethal level in at least 2 species (1 rodent and 1 non-rodent).

Both are true.

3

Which of the following is/are true about subacute and chronic toxicity?
A. Required for most agents, especially those intended for chronic use.
B. Duration of testing is 2-4 weeks for subacute and 6-24 months for chronic use.
C. Testing is in at least 2 species.

All are true.

4

True or False.
The pharmacologic profile includes the description of all the pharmacologic effects. Also gathered are both graded and quantal dose-response data.

True

5

What FDA drug category is being described?
Controlled studies in women fail to demonstrate a risk to the fetus...

Category A

6

What FDA drug category is being described?
Either animal reproduction studies have demonstrated a fetal risk but there are no controlled studies in pregnant women...

Category B

7

What FDA drug category is being described?
... studies in animals have revealed adverse effects on the fetus ...

Category C

8

What FDA drug category is being described?
There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk...

Category D

9

What FDA drug category is being described?
... The drug is contraindicated in women who are or may become pregnant.

Category X

10

What FDA drug category is being described?
Folic acid, thyroid hormones

Category A

11

What FDA drug category is being described?
Zidovudine

Category B

12

What FDA drug category is being described?
Aspirin

Category C

13

What FDA drug category is being described?
ACE inhibitors, anticonvulsants

Category D

14

What FDA drug category is being described?
Statins, OCPs, clomiphene, misoprostol, high-dose vitamin A

Category X

15

What are the teratogenic effects of these drugs to the fetus/offspring?
ACE inhibitors
Antiepileptic drugs
Phenytoin

ACE inhibitors - fetal renal damage
Antiepileptic drugs - neural tube defects
Phenytoin - fetal hydantoin syndrome

16

What are the teratogenic effects of these drugs to the fetus/offspring?
Oral hypoglycemic agents
Barbiturates
Diethylstylbestrol

Oral hypoglycemic agents - neonatal hypoglycemia
Barbiturates - neonatal dependence
Diethylstylbestrol - vaginal clear cell adenocarcinoma

17

What are the teratogenic effects of these drugs to the fetus/offspring?
Ethanol
Lithium
Isotretinoin

Ethanol - fetal alcohol syndrome
Lithium - Ebstein's anomaly
Isotretinoin - craniofacial malformations

18

What are the teratogenic effects of these drugs to the fetus/offspring?
Iodide
Misoprostol
Penicillamine

Iodide - congenital hypothyroidism
Misoprostol - Möbius sequence
Penicillamine - cutis laxa

19

What are the teratogenic effects of these drugs/activities to the fetus/offspring?
Thalidomide
Smoking
Tetracycline

Thalidomide - phocomelia
Smoking - IUGR
Tetracycline - tooth discoloration

20

What are the teratogenic effects of these drugs to the fetus/offspring?
Streptomycin
Methimazole
Sulfonamides
Fluoroquinolones

Streptomycin - ototoxicity
Methimazole - aplasia cutis congenita
Sulfonamides - kernicterus
Fluoroquinolones - cartilage damage

21

What are the teratogenic effects of warfarin in the first, second, and third trimesters?

1st - chondrodysplasia
2nd - CNS malformations
3rd - bleeding diathesis

22

A standard in vitro test for mutagenicity which uses a special strain of Salmonella that naturally depends on specific nutrients. The loss of this dependence signals a mutation.

Ames Test

23

An in vivo mutagenicity test carried out in mice in which 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.

Dominant lethal test

24

True or False.
There is a high degree of correlation between mutagenicity in the Ames test and carcinogenicity in some animal tests.

True

25

True or False.
Phase 1 Clinical Trial involves careful evaluation of the dose-response relationship and pharmacokinetics among normal human volunteers (25-100) except for studies for cancer and highly toxic agents which use fewer volunteer patients with target disease. This phase answers the question, "Is the drug safe for humans?"

True

26

True or False.
Phase 2 clinical trial answers the question, "Is the drug effective?" It moderate number (100-200) of patients with the target disease are involved. Either single-blind or double-blind design is used.

True.

27

True or False.
Phase 3 clinical trial uses a large design involving many patients (1000-5000), including those considered as special population (with conorbids, extremes of ages, pregnant patients). It uses a double-blind cross-over design.

NOTE: "Is it as good or better compared to the new treatment of current stand of care?" From PrevMed page 16 of 50

True

28

True or False.
Phase 4 clinical trial is he post marketing surveillance phase.

True

29

True or False.
For a generic drug to be considered a bioequivalent, it should fall within 85% to 125% of the Cmax, tmax, and AUC of the innovator drug.

True

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