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Biopharmaceutics > MODULE 1 > Flashcards

MODULE 1 Flashcards

1
Q

Intended for diagnosis, cure, mitigation, treatment, or prevention of disease

A

Drug

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2
Q

Give the Dosage Forms:

A

Solid (tablet, capsule)
Semisolid (ointment, creams)
Liquids
Suspension
Emulsion

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3
Q

Considered as drug delivery system as it release and deliver drugs to site of action

A

Drug products

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4
Q

Designed to meet patient needs such as Palatability, Convenience, and Safety

A

Drug products

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5
Q

Examines the interrelationships of physical/chemical properties of drug

A

Biopharmaceutics

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6
Q

Rate and extent of drug absorption

A

Bioavailability

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7
Q

Measures the availability of the drug

A

Bioavailability

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8
Q

Described as the sequence of events that precedes elicitation of drugs therapeutic effect

A

Drug substance and Drug formulation

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9
Q

Drug is released from dosage form

A

Liberation

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10
Q

Where drug reached the site of action

A

Distribution

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11
Q

Results when site of action reaches or exceeds the minimum effective concentration

A

Pharmacodynamic response

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12
Q

Tiniest amount of drug that produce a pharmacologic effect

A

MEC

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13
Q

It is where the Starting dose, Maintenance dose, Dosage form, and Dosing intervals are determined

A

Clinical trials

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14
Q

Provides a scientific basis on product design and product development

A

Biopharmaceutics

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15
Q

Most important steps in manufacturing process is termed what?

A

Critical manufacturing variable

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16
Q

It involves Test apparatus and equipments and no involvement of Laboratory animals or humans.

A

In vitro methods

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17
Q

It involves humans and laboratory animals

A

In vivo methods

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18
Q

Science of kinetics of drug absorption, distribution and elimination.

A

Pharmacokinetics

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19
Q

Description of drug distribution and elimination is often termed as what?

A

Drug disposition

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20
Q

Pharmacokinetics involves 2 approaches/aspects. What are these?

A

Experimental aspect
Theoretical aspect

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21
Q

Involves development of biologic sampling techniques, analytical methods for the measurement of drugs and metabolites

A

Experimental aspect

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22
Q

Involves development of pharmacokinetics models that predicts drug disposition

A

Theoretical aspects

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23
Q

Integral part of pharmacokinetic studies

A

Statistics

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24
Q

Used for pharmacokinetic parameter estimation and data interpretation

A

Statistical methods

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25
Q

FDA approved label

A

Package insert

26
Q

Drug concentration below MEC

A

Subtherapeutic

27
Q

Drug concentration above the MTC

A

Toxic response

28
Q

It involves multidisciplinary approach

A

Clinical pharmacokinetics

29
Q

Study of pharmacokinetic differences of drugs in various population

A

Population pharmacokinetics

30
Q

True or False

Clinical pharmacokinetics is also applied to Therapeutic drug monitoring.

A

True

31
Q

Example of Prothrombin clotting time

A

WARFARIN / PLDTWG

32
Q

Drugs that are frequently monitored

A

Aminoglycosides
Anticonvulsants

33
Q

Drugs that are closely monitored

A

Cancer chemotherapy

34
Q

Study of drug effect including distribution and disposition due to genetic differences. Is also the main reason why many new drugs have to be further studied

A

Pharmacogenetics

35
Q

Related field which emphasizes different aspects of genetic effect on drug response.

A

Pharmacogenomic

36
Q

Its measurements can confirm whether the drug dose is subtherapeutic or was not responsive to the drug therapy

A

Plasma drug concentration

37
Q

Study of the biochemical and physiological effects of drugs on body.

A

Pharmacodynamic

38
Q

Molecules that interacts with specific drugs to produce pharmacologic effect on body

A

Receptors

39
Q

Refers to the relationship between drug concentration and pharmacologic response.

A

Pharmacodynamic

40
Q

Refers to the dose (drug input to the body) and various measures of acute or integrated drug conc. & other biological fluids (Cmax, Cmin, Css)

A

Drug exposure

41
Q

Refers to direct measure of the pharmacologic effect of drug.

A

Drug response

42
Q

Provides information on safety and effectiveness of drug during development .

A

Toxicologic and Efficacy studies

43
Q

Application of pharmacokinetic principles to design, conduct, and interpretation of drug safety.

A

Toxicokinetics

44
Q

Aids in the interpretation of toxicologic findings in animals and extrapolation of resulting data to humans.

A

Toxicokinetic data

45
Q

Performed in animals during preclinical drug development.

A

Toxicokinetic studies

46
Q

Study of adverse effects of drugs and toxic substances such as poisons in body.

A

Clinical Toxicology

47
Q

Drugs frequently involved in toxicity cases includes:

A

Acetaminophen
Salicylate
Opiates
TCAs

48
Q

Causes an increase in heart rate when given intravenously but has no observable effects on the heart when given orally.

A

Isoproterenol

49
Q

May differ from one drug to another containing the same drug, even the same route of administration.

A

Bioavailability

50
Q

Provides a scientific basis for drug design and drug development.

A

Biopharmaceutics

51
Q

May affect the drug product performance including the release of drug from drug product.

A

Excipient

52
Q

Science of kinetics of Drug absorption, distribution, and elimination - ( metabolism and excretion)

A

Pharmacokinetics

53
Q

The most important steps of the manufacturing process are termed what?

A

Critical manufacturing variable

54
Q

Main reason why many drugs still have to be further studied after regulatory approval.

A

Pharmacogenetics

55
Q

Is it desirable that this occurs at drug concentration higher relative to the therapeutic drug concentrations

A

Adverse drug reaction

56
Q

Oral

A

Mouth

57
Q

Sublingual

A

Under the tongue

58
Q

Parenteral

A

By injection

59
Q

Intraosseous

A

Bone

60
Q

Intra-articular

A

Joint

61
Q

Intrasynovial

A

Joint fluid area

62
Q

Aural

A

Ear

Biopharmaceutics (2 decks)

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