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CNPR: Pharmaceutical Sales Training Manual - Revised 17th Edition > Chapter 10: Preclinical Studies > Flashcards

Chapter 10: Preclinical Studies Flashcards

1
Q

An ideal drug is potent, efficacious, and specific. True or false?

A

True

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2
Q

No drugs are perfectly effective and absolutely safe in reality. True or false?

A

True

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3
Q

What is the study of drug movement throughout the body?

A

Pharmacokinetics

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4
Q

The processes of pharmacokinetics are grouped into four categories:

A

Absorption
Distribution
Metabolism
Excretion

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5
Q

What are the four basic transport mechanisms?

A

Passive diffusion
Facilitated diffusion
Active transport
Pinocytosis

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6
Q

What is passive diffusion?

A

Diffusion is the random movement of molecules in fluid.

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7
Q

What is facilitated diffusion?

A

Polar drug molecules have been observed across cell membranes via carrier systems.

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8
Q

What is active transport?

A

The active transport mechanism requires energy to drive the transportation of drugs against the concentration gradient from low to high.

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9
Q

What is pinocytosis?

A

This involves engulfing of fluids by a cell.

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10
Q

Absorption is the primary pharmacokinetic factor determining the length of time it takes a drug to produce its effect. True or false?

A

True.

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11
Q

Distribution involves the transport of drugs throughout the body. True or false?

A

True

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12
Q

The primary site of drug excretion is the kidney. True or false?

A

True

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13
Q

Certain drugs may be excreted more quickly, if the pH of the filtrate changes. True or false?

A

True

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14
Q

Impairment of kidney function can dramatically affect pharmacokinetics. True or false?

A

True

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15
Q

Glandular activity is another elimination mechanism. True or false?

A

True

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16
Q

What do toxicological studies show?

A

The functional and morphological effects of the drug

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17
Q

The two types of toxicity studies are:

A

Single-dose and repeated dose

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18
Q

Single dose toxicity tests are:

A

Acute toxicity testing is conducted for several purposes:

Determination of repeated doses

Identification of organs subjected to toxicity

Provision of data for starting doses in human clinical trials

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19
Q

Repeated dose toxicity tests are:

A

Chronic toxicity studies are also performed on two species, a rodent, and a non-rodent. The aim is to evaluate the longer term effects of the drug in animals.

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20
Q

Carcinogenicity studies are carried out to identify the tumor causing potential of a drug. True or false?

A

True

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21
Q

Genotoxicity studies determine if the drug compound can induce mutations to genes. True or false?

A

True

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22
Q

Reproductive toxicology studies are to assess the effect of the potential drug on mammalian reproduction. True or false?

A

True

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23
Q

T 1/2 is:

A

Plasma half life

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24
Q

The longer it takes a medication to be excreted the greater the half life. True or false?

A

True

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25
Q

For any drug administered, the goal is to keep its plasma concentration in the therapeutic range. True or false?

A

True

26
Q

A drug that is more potent, will produce a therapeutic affect at a lower dose. True or false?

A

True

27
Q

Efficacy, is the magnitude of maximal response that can be produced from a particular drug. True or false?

A

True

28
Q

A cellular macromolecule to watch a medication binds in order to initiate its effects is called a receptor. True or false?

A

True

29
Q

A drug that produces the same type of response as the endogenous substance is called an agonist. True or false?

A

True

30
Q

The term partial agonist or agonist-antagonist drug describes a medication that produces a weaker response than an agonist. True or false?

A

True

31
Q

Functional antagonists inhibit the effects of an agonist by changing pharmacokinetics factors. True or false?

A

True

32
Q

What is NOAEL?

A

No observed adverse effect level

33
Q

What is MRSD?

A

Maximum recommended starting dose

34
Q

What is HED?

A

Human equivalent dose

35
Q

DNA is:

A

Deoxyribonucleic acid

36
Q

RNA is:

A

Ribonucleic acid

37
Q

Three types of subatomic particles:

A

Protons, neutrons, and electrons

38
Q

The atomic mass of an element is what?

A

The sum of the protons and neutrons in the element

39
Q

What is a hydrogen bond?

A

This occurs when two atoms associate with a hydrogen atom

40
Q

What is an ionic (electrovalent) bond?

A

Occurs when the valance electrons transfer from one atom to another

41
Q

What is a covalent bond?

A

This forms when atoms share pairs of valence electrons

42
Q

What are triglycerides?

A

The most abundant, lipid in both food and the body. These are neutral fats, that insulate, protect and serve as the body’s most concentrated energy source.

43
Q

What are phospholipids?

A

These are the major structural component of cell membranes, and consist of one molecule of glycerol two molecules of a fatty acid, and a phosphate group.

44
Q

What are steroids?

A

Simple lipids, with no fatty acids in their molecules.

45
Q

What holds DNA together?

A

Adenine-thymine and guanine-cytosine pairs

46
Q

RNA has a single chain structure. True or false?

A

True

47
Q

Genetic factors of a marked effect on the effectiveness of certain medicines. True or false?

A

True

48
Q

Genetics is the study of what?

A

Heredity

49
Q

What are the two types of human gametes?

A

Eggs (ova)
Sperm (spermatozoa)

50
Q

An ovum contains 23 chromosomes and a sperm contains 23 chromosomes. When they unite what happens?

A

A fertilized cell with 46 chromosomes (23 pairs) in its nucleus

51
Q

The two sex chromosomes of the 23rd chromosome pair determine a persons gender. True or false?

A

True

52
Q

What is the genotype?

A

The genetic information stored at a locus of a gene.

53
Q

The detectable outward manifestation of a genotype is called what?

A

Phenotype

54
Q

The area of pharmacology that examines the role of heredity and drug response is what?

A

Pharmacogenetics

55
Q

What is homozygous?

A

Identical alleles

56
Q

What is heterozygous?

A

Different alleles

57
Q

Variations of the same gene are called alleles. True or false?

A

True

58
Q

What are genetic defects?

A

These results from changes to genes or chromosomes

59
Q

What are teratogens?

A

Environmental agents that can cause structural or functional defects in the developing fetus

60
Q

What are mutations?

A

A permanent change in genetic material

61
Q

What are congenital anomalies?

A

Birth defects

CNPR: Pharmaceutical Sales Training Manual - Revised 17th Edition (11 decks)

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