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Phardose > Chapter 2 Lec > Flashcards

Chapter 2 Lec Flashcards

0
Q

Differentiate the effect and potency of the test agent from those of control

A

Bioassaya

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1
Q

Ability of cells w the potential to produce a desired antibody

A

Monoclonal antibody

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2
Q

Body’s means of transforming nonpolar molecules to polar compounds

A

Biochemical transformation

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6
Q

Useful in treatment of diabetes mellitus

Also has anti tumor capabilities

A

Periwinkle or vinca rosea

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7
Q

Chemical alteration

A

Molecular modification

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8
Q

Basic techniques that has the ability to manipulate and produce proteins

A

Recombinant DNA and monoclonal antibody

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9
Q

Has the potential to produce any protein

Genetic material can be transplanted from higher species to a lowly bacteriun

A

Recombinant dna

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10
Q

Medical intervention based on the modification of the genetic material

A

Human gene therapy

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11
Q

Molecular modification to design a drig that interferes with the known biochemical pathway

A

Mechanism based drug design

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12
Q

Produce the specifically desired effect

No side effects

A

Goal drug

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13
Q

Undertaken to reveal any effect of an active ingredient on mammalian reprod

A

Reproduction studies

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14
Q

Clinical trial materials

A

New drug, placebo and the drug product which the new prof is to be compared

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15
Q

Prototype chemical compound that had a fundamental desired biologic or pharmacologic activity

A

Lead compound

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16
Q

Involves testingg of large numbers of synthetic organic compounds

A

Random or un targeted screening

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18
Q

A compound that requires metabolic biotransformatiin after administration to produce the desired pharmacologically active compound

A

Prodrug

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19
Q

Allows vets to prescribe extra label uses or animal drugs and human drugs for animals

A

Animal medicinal drug use of clarification act of 1994

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20
Q

2 animal species for drug metabolism

A

Rodent and dog

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21
Q

Special care of the prescriber and patient in the use of the drug

A

Precautions

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22
Q

First pass effect

A

Drugs thru liver and exposure to hepatic enzymes

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23
Q

45% sucess

A

Phase 2

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25
Q

20-100 subjects

A

Phase I- healthy subjects

27
Q

Controlled in which atleast one of the parties does not know which producy is being administered

A

Blind studies

30
Q

Quantitative range or amount of drug that may be prescribed safely

A

Usual dosage rangr

32
Q

2 weeks at 3 dosage lvls to 2 animals

A

Subacute or subchronic studies

33
Q

Used to gather supplemental info that may contain support certain labeling requests

A

Phase 3b studied

34
Q

To test if the comp can affect gene mutation

A

Genotoxicity

35
Q

Speed at which a drug substance dissolves in a medium

A

Dissolution rate

36
Q

Undertake when the comp has shown sufficient promise as a drug to enter human clinical trials

Carried out in rats and mouse strains
18-24 months

A

Carcinogenic studies

37
Q

Orphan drug act of 1983

A

Rare diseases that affects lower than 200,000 people

38
Q

Objective is to make promising drugs available to desperately ill patients

A

Treatment IND

40
Q

67% success

A

Phase I

41
Q

Controlled clinical studied to evaluate effectiveness of a drug in patients with the condition for which the drug is intended for

A

Phase 2- unhealthy subjects

43
Q

100-1000 patients
Last for 1-4 trs
Safety effectiveness and sosge
5-10%

A

Phase 3

44
Q

Fda approved indication prevention or diagnosis

A

Indication and usage

45
Q

May influence a drugs action by altering its pharmacokinetic profile

A

Genetic polymorphism

46
Q

Amount that is enough to achieve the drugs optimum therapeutic effect

A

Dose of drug

47
Q

Nonclinical lab studied may be omitted

Duplicates or generic copies

A

Abbreviated new drug application

48
Q

Predictable and unpredictable undesired effects

A

Adverse rxns

49
Q

Descriptjon of the adverse reactions and safety hazards

A

Warnings

50
Q

Summary of all actions of drugs

A

Clinical pharmacology

51
Q

A tranquilizer and a hypotensive agent

A

Reserpine

52
Q

First human gene therapy

A

Adenosine deaminase deficiency

53
Q

Risk of use clearly outweighs any beneficial effecy

A

Contraindication

55
Q

Biochemical transformation results in..?

A

Production of metabolites

59
Q

Ability to endure the influence of the drug

A

Tolerance

60
Q

Rectal buccal administration

A

Drugs are absorbed into the systemic circularion through blood vessels

62
Q

Initial intro

Purpose of assessing safety

A

Phase I - healthy subjects

66
Q

deals w the adverse or undesired effects of drugs

A

Toxicology

69
Q

Capable of examining 15,000 chem compounds a week using 10-20 biologic assays

A

High throughout screening

76
Q

Determine the toxic effects over a short period of time

A

Acute toxicity studies

Phardose (7 decks)

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