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BPS 4 > Final exam > Flashcards

Final exam Flashcards

1
Q

Some drugs do not need comparative bioavailability testing. Which types of drugs are these?

A

Drugs injected directly into the blood stream

Comparative bioavailability studies measure the level fo a medicinal ingredient in the blood of a healthy human volunteer

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2
Q

Do the quality standards for brand name drugs and generic drugs differ?

A

No, the quality standards are the same

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3
Q

The ingredients, manufacturing processes and facilities for all drugs must meet:

A

The federal guidelines of Good Manufacturing Practices

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4
Q

Drug manufacturers must perform a series of tests both during and after production to show that:

A

Every drug batch made meets the requirements for that product

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5
Q

Défine pharmaceutical equivalence

A

Two drug products that have the same active ingredient, dosage form, strength, route of administartion and condtions of use

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6
Q

Define bioequivalence

A

The term used to describe substantially similar rate and extent of absorption of the active ingredient

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7
Q

Bioequialence verifies that the active ingredient in a generic drug will be absorbed into the body to the same____ and ____ as its corresponding reference product

A
  • Extent
  • Rate
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8
Q

When 2 drugs are deemed bioequivalent, they are expected to have the same profile for ____ and ____ When administered under the conditions listed in the product labeling

A
  • Safety
  • Efficacy
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9
Q

Define therapeutic equivalence

A

A generic drug product that contains the same active ingredient in the same dose in the same dosage form, and demonstrates bioequivalence

It may be substituted for the innovator product as permitted by provincial and territorial formularies

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10
Q

Bioequivalent data provides an estimte of:

A
  • The fraction of the drug absorbed
  • The rate of absorption
  • Drug’s distribution and elimination
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11
Q

Why may bioavailability studies be required for new formulations?

A

If there is a change in inactive ingredient of a drug product already approve, to ensure that the change in ingredient will not significantly affect the performance of the drug in patients

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12
Q

Define absolute bioavailability

A

The fraction of the administered dose that reaches the systemic circulation relative to an IV dose

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13
Q

Define relative bioavailability

A

The fraction of the dose of a test product that reaches the systemic circulation relative to a non-i.v reference product

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14
Q

How do we determine absolute bioavailability?

A

By measuring the concentration of the therapeutic ingredient and/or its therapeutic metabolite(s), in blood, as a function of time

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15
Q

What is the therapeutic index?

A
  • The relationship between desired and undesired effects of a drug
  • The ratio between a drug’s median toxic dose and its median effective dose
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16
Q

Define the median toxic dose

A

Toxic effect in 50% of the people tested

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17
Q

Define the median effective dose

A

Desired effective efect in 50% of the people tested

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18
Q

Bioavailability data are used to determine:

A
  • The amount of drugs absorbed
  • The rate at which the drug was absorbed
  • The duration of the drug,s presence in the bioloic fluid or tissue correlated to the patient’s response
  • The relationship between drug blood levels and clinical efficacy and toxicity
  • To compare different dosage forms of a drug
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19
Q

What is the deciding factor for whether or not a drug candidate is selected for further development?

A

Bioavailability

It should be investigated early in drug development and used throughout development

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20
Q

The bioavailability of a drug depends on:

A
  • Physicochemical properties of the drug substance
  • Route of administration
  • Non-medicinal ingredients
  • Manufacturing process
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21
Q

Bioavailability helps to elucidate:

A
  • Process by which a drug is released from its dosage forma nd reaches the sites of action
  • Impact of pre-systemic metabolism and/or transpprters
  • Drug’s pharmacokinetic properties
  • Effect of food on absorption
  • Relative bioavailability
  • Information on labeling or formulation optimization
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22
Q

Bioavailability studies compare the performance of two drugs with the same:

A
  • Drug
  • Dosage form
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23
Q

Bioequivalence studies will be applied to any systematically available drug product that:

A

Wille be used to provide therapeutic effects at an active site different from the site of absorption:
* Oral tablets
* Capsules and suspensions
* Transdermal products
* Nasal or rectal dosage forms

Oral solutions are excluded since their behaviours are expected to not be different between products

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24
Q

Bioequivalence studies are carried out in how many phases?

A

2

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25
Q

Describe the first phase of bioequivalence studies

A

Healthy, fasted volunteers are randomized into two groups: one recieves the reference (innovator) dosage form, the other the test (generic) dosage form in the first period of the study

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26
Q

Describe the second phase of bioequivalence studies

A

After the first dose has been eliminated, the subjects recieve the other dosage form

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27
Q

When are blood samples taken during a bioequialency test?

A

At established intervals

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28
Q

What is analyzed in the blood samples from bioequivalence studies

A

Drug and/or metabolites

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29
Q

What parameters are determined from the blood samples during a bioequivalence test? What can this prove

A
  • Cmax
  • Tmax
  • AUC

To be therapeutically equivalent to a reference product, there must be no statistically significant different in the above parameters

30
Q

What is the acceptable average differences in the test paramaters between reference and generic products during a bioequivalency test?

A

3-4%

31
Q

What is a key consideration when selecting a dosage form?

A

Whether it is intented for local of systemic effects

32
Q

Different dosage forms generally result in different:

A
  • Absorption rates
  • Times of onset
33
Q

The difference in absorption between dosage forms is a function of the:

A
  • Formulation
  • Route of administration
34
Q

What percentage of marketed medicine is delivered orally?

A

90%

35
Q

Which dosage form contributes to patient compliance the most?

A

Oral dosage forms

36
Q

Oral dosage forms can be which types of formulation?

A
  • Solid dosage forms: tablets and capsules
  • Liquid dosage forms
37
Q

What are some of the major challenged of immediate release oral delivery?

A
  • Variability of the amount of drugs absorbing into the circulatory system
  • Difficulty swallowing
  • Certain drugs (such as nonsteirodal anti-inlfammatory drugs) can become lodged into the esophagus and damage the esophagal mucosa
38
Q

How is the gastric emptying affect liquid and solid dosage forms?

A
  • Liquid: faster gastric emptying
  • Oral: slower gastric emptying
39
Q

What is the general disintegration time of capsules in the GI track?

A

Within 6 minutes

40
Q

What is the general disintegration time of tablets in the GI track?

A

Within 15 minutes

41
Q

What are some challenged when considering the small intestine?

A
  • Influx transporters are found in the duodenum and jejunum
  • Many drugs are metabolized by CYP 450 (CYP 3A4)
  • Several drugs are effluxed back onto the intestine’s lumen
42
Q

What are the main challenges of the stomach?

A
  • Acidity
  • Enzymes
43
Q

What are the main challenges of the small intestine?

A
  • Food products
  • Enzymes
  • Dissolution
44
Q

What are the main challenges of the liver?

A
  • Entero-hepatic loop
  • First-pass effect
45
Q

What are the main challenges of the blood?

A
  • Protein binding
46
Q

What are the main challenges of the site of therapeutic action?

A
  • Small fraction of dose taken
47
Q

Most ingredients in pharmaceutical dosage forms occur in solid states as:

A
  • Amorphous powders
  • Crystals
48
Q

Define powder

A

Intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use

49
Q

What physical and chemical characteristics are acertained before the use of a solid material in a drug?

A
  • Morphology
  • Purity
  • Solubility
  • Flowability
  • Stability
  • Particle size
  • Uniformity
  • Compatibility with other components
50
Q

Solid materials are subjected to various treatments to enable:

A
  • Efficient production of the finished dosage form
  • Optimum therapeutic efficacy
51
Q

Medicinal & non medicinal ingrediant powders are:

A
  • Blended to produce solid dosage forms
  • Suspended in liquid vehicles
  • Inforporated in semi-solid bases to prepare creams or ointments
  • Agglomerated into granules
52
Q

What is the general size range of particles of pharmaceutical powders?

A

1mirco-meter-10mm

53
Q

What are the United States Pharmacopeia’s classification of particle size?

A
  • Very coarse
  • Coarse
  • Moderately coarse
  • Fine
  • Very fine
54
Q

Particle sizes influence important factors, such as:

A
  • Dissolution rate
  • Suspendability
  • Uniform distribution
  • Penetrability
  • Lack of gritiness
55
Q

How does particle size affect dissolution rate?

A
  • Dissolution rate is extended for larger particles because microionization improves dissolution rate
  • Reduced for smaller particle sizes
56
Q

How does particle size affect suspendability?

A
  • Finer dispersions require paryocle size of 0.5-10 micrometers
  • Larger particle sizes may prevent suspendability
57
Q

How does particle size affect uniform distribution?

A
  • For the drug substance in the powder mixture or solid dosage form
  • To ensure dose-to-dose content uniformity
58
Q

How does particle size affect penetrability?

A
  • For particles to be inhaled
  • Required particle size of 1-5 micrometers
59
Q

How does particle size affect lack of gritiness?

A
  • In creams, ointments etc.
  • Required particle size of 50-100 micrometers
60
Q

What is a granule?

A

Agglomerates of smaller particles of powder

61
Q

By what two methods can granules be prepared?

A
  • Wet methods
  • Dry methods
62
Q

Describe the wet method of granule preperation

A
  • Moisten the powder
  • Pass through a screen of desired mesh size
  • Dry by air or heat
63
Q

Describe the dry method of granule preperation

A
  • Powders passed through a roll compactor
  • Passed through granulating machine for desired particle size
64
Q

What are the advantages of granules over powders?

A
  • Better flowing properties
  • Reduced surface area = more stable to humidity, less likely to cake or harde
  • More easily wetted by liquids = perferred for products to be constituted into solutions/suspensions (certain antibiotic drugs)
65
Q

Why are effervescent granulated salts made?

A

To mask undesirable taste of medicinal agents

66
Q

What are effervescent granulated salts made of?

A

Granules generally containing a dry mixture of:
* Medicinal ingredients
* Sodium bicarbnate
* Citric acid
* Tartaric acid

67
Q

What happens when an effervescent tablet is added to water?

A
  • The acids and bases react
  • Liberation of CO2
68
Q

What is a key consideration when developping tablets?

A

Exposure of the drug substance to the dissolution process may involve a few steps: dosage form –> granules –> fine particles

69
Q

Name the process that happens from a dosage form to granules

A

Disintergration

70
Q

Name the process that happens from granules to fine particles

A

Deaggregation

71
Q

Name different types of tablets

A
  • Compresed tablets
  • Film-coated tablets
  • Enteric-coated tablets
  • Buccal and sublingual tablets
  • Chewable tablets
72
Q

What are some qualities that tablets must have?

A
  • Accurate and uniform weight
  • Homogeneity
  • Absence of incompatilibilites
  • Stability and hardness
  • Ease of disintergration
  • Reasonable size and shape
  • Pleasing appearance
  • Easy of manufacturing
  • Economy of production

BPS 4 (2 decks)

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