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Pharmacology > V - Drug Regulation > Flashcards

V - Drug Regulation Flashcards

1
Q

Required before human studies begin

A

Animal Testing

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2
Q

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

A

Animal Testing

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3
Q

Required for all new drugs

A

Acute Toxicity

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4
Q

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

A

Acute Toxicity

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5
Q

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

A

Subacute and Chronic Toxicity

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6
Q

Duration: Subacute Toxicity

A

2-4 weeks

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7
Q

Duration: Chronic Toxicity

A

6-24 months

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8
Q

Description of all the pharmacologic effects of a drug

A

Pharmacologic Profile

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9
Q

Pharmacologic profiles require _____ data.

A

graded and quantal dose-response

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10
Q

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

A

Reproductive Toxicity

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11
Q

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

A

A

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12
Q

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

A

B

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13
Q

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

A

C

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14
Q

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

A

D

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15
Q

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

A

X

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16
Q

Induction of developmental defects in the somatic tissues of the fetus

A

Teratogenesis

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17
Q

Teratogenesis is studied by

A

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

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18
Q

Teratogens: ACE Inhibitors

A

fetal renal damage

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19
Q

Teratogens: Anti-epileptic Drugs

A

neural tube defects

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20
Q

Teratogens: Phenytoin

A

fetal hydantoin syndrome

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21
Q

Teratogens: Oral Hypoglycemic agents

A

neonatal hypoglycemia

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22
Q

Teratogens: Barbiturates

A

neonatal dependence

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23
Q

Teratogens: Diethylstilbestrol (DES)

A

vaginal clear cell adenoCA

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24
Q

Teratogens: Ethanol

A

fetal alcohol syndrome

25
Q

Teratogens: Lithium

A

Ebstein’s anomaly

26
Q

Teratogens: Isotretinoin

A

craniofacial malformations

27
Q

Teratogens: Iodide

A

congenital hypothyroidism

28
Q

Teratogens: Misoprostol

A

Mobius sequence

29
Q

Teratogens: Penicillamine

A

cutis laxa

30
Q

Teratogens: Thalidomide

A

phocomelia

31
Q

Teratogens: Smoking

A

IUGR

32
Q

Teratogens: Tetracycline

A

tooth discoloration

33
Q

Teratogens: Streptomycin

A

ototoxicity

34
Q

Teratogens: Methimazole

A

aplasia cutis congenita

35
Q

Teratogens: Sulfonamides

A

kernicterus

36
Q

Teratogens: Fluoroquinolones

A

cartilage damage

37
Q

Teratogens: Warfarin in the 1st Trimester

A

chondrodysplasia

38
Q

Teratogens: Warfarin in the 2nd Trimester

A

CNS malformations

39
Q

Teratogens: Warfarin in the 3rd Trimester

A

bleeding diatheses

40
Q

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

A

Mutagenesis

41
Q

Standard in vitro test for mutagenicity

A

Ames Test

42
Q

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

A

Ames Test

43
Q

In vivo mutagenicity test carried out in mice

A

Dominant Lethal Test

44
Q

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

A

Dominant Lethal Test

45
Q

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

A

Carcinogenesis

46
Q

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

A

Clinical Trial

47
Q

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

A

Investigational New Drug

48
Q

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

A

New Drug Application

49
Q

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

A

Phase I Trial

50
Q

Clinical Trial Phases: Is it safe?

A

Phase 1 Trial

51
Q

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

A

Phase 2 Trial

52
Q

Clinical Trial Phases: Is it effective?

A

Phase 2 Trial

53
Q

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

A

Phase 3 Trial

54
Q

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

A

Phase 4 Trial

55
Q

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

A

Drug Patent

56
Q

A new version of a patented drug must be

A

bioequivalent

57
Q

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

A

bioequivalent

58
Q

Used in determining safety and efficacy of generic drugs

A

Bioequivalence

59
Q

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

A

Orpan Drug

Pharmacology (34 decks)

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