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Kinetics > Exam 4 > Flashcards

Exam 4 Flashcards

1
Q

The relative amount of an administered dose that reaches the general circulation and the rate at which this occurs

A

Bioavailability

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2
Q

A requirement imposed by the FDA for in-vitro and or Invivo testing of specified drug products, which must be satisfied as a condition for marketing

A

Bioequivalence Requirement

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3
Q

Term used to describe pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability when studied under similar experimental conditions

A

Bioequivalent drug

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4
Q

Drug products that contain the same therapeutic moeity but as different salts, esters, or complexes

Different dosage forms and strengths within a product line are?

They are not?

A

Pharmaceutical alternatives

They arent interchangable

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5
Q

Drug products in identical dosage forms that contain the same active ingredient but may differ in characteristics such as shape, scoring, packing, expiration time

A

Pharmaceutical equivalent

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6
Q

The process of dispensing a pharmaceutical alternative for the prescribed drug product. For example, ampicillin suspension is dispensed in place of tetracycline

A

Pharmaceutical substitution

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7
Q

Considered to be _____ only if they are pharmaceutical equivalents and can be expected to produce the same clinical effect and safety profile when administered to patient under the conditions specified in the labeling

A

Therapeutic equivalent

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8
Q

This involves dispensing a therapeutic alternative in place of the prescribed drug

Example: Amoxicillin in place of ampicillin or ibuprofen in place of naproxen

Can also occur when an NDA approved drug is substituted for the same drug, which has been approved by a different NDA

Nicoderm for nicotrol

A

Therapeutic substitution

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9
Q

The fraction absorbed from an oral, IM or SC formulation may be determined by calculating the AUC obtained from IV bolus injection as compared to the AUC achieved from the same dose given orally (IM or SC) to the same subject

A

Fabs

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10
Q

Fabs=?

A

Amount absorbed from the non-IV route

/

Amount absorbed from the IV route

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11
Q

The amount of drug absorbed from one drug product as compared to recognized standard

A

Relative Oral bioavailability

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12
Q

equation for relative bioavailability

A
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13
Q

This make also be used to determine relative availability as long as the total amount of intact drug is collected

A

Urinary excretion data

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14
Q

Can be used as an approximate indication of drug absorption rate

A

Tmax

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15
Q
  • Often related to pharmacodynamic effect
  • Often used in bioequivalence studies as a measure for the rate of drug bioavailability
A

Cmax

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16
Q
  • Measure the extent of drug absorption
  • Quantitatively ____ is decribed by?
A

AUC

17
Q

This can be used if the following criteria are satisfied

Urinary drug excretion

A
  • A significant fraction of the drug is excreted unchanged in the urine
  • Collection must be made over an interval representing at least six biological half lives of the drug
  • Effects due to variations in the urinary pH volume, on excretion rate must be minimized
  • Complete urine samples
18
Q

Considered to be the least accurate approach fro bioavailability determination and is the least sensitive to difference

A

Clinical Observation

19
Q

Bioavailability determination

Utilized if quantative measurement of the drug substance is not possible

Utilized for locally acting drugs; non-systemically absorbed drugs

Measure the effect over a period of time so that an effect time curve can be established

Significantly more variable than plasma/urine concentration determination

A

Acute Pharmacodynamic effect

20
Q

Drug substance/Drug product physical chemical issues

  • Drug substance has?
  • Dissolution rate is?
  • Partical size is known to be critical for adequate bioavailability
  • Certain forms dissolve poorly
  • The drug has a high ratio?
A
  • Low aqeous solubility
  • Dissolution rate is slow (<50% in 30 minutes
  • excipients to active ingredients
21
Q

Drug Biological issues

  • Specific formulation are ___ or interfere with absorption
  • The active agent is absorbed?
  • The degree of absorption is <__ as compared to IV
  • There is significant _______ so that the rate of absorption is unusually important for therapy
  • The drug is rapidly ____ so that rapid dissolution or absorption are required for effectiveness
  • The active agent is ____ in specific areas of the GI tract
  • The drug product is subject to _____ kinetics near the therapeutic range, thus?
A
  • required
  • in a particular part of the GI tract
  • 50%
  • pre-systemic metabolism
  • metabolized or excreted
  • unstable
  • dose-dependent, thus the rate and extent of absorption are important in establishing bioequivalence
22
Q

Crossover latin square design

A
  • Study wherein each subject serves as their own control
  • Example: each subject receives each formulation after a suitable washout period in a random fashion
23
Q

Latin Square Designs

  • Exposure and elimination aspects
    • Plan a clinical trial in that each subject?
  • Control aspects
    • Each subject is? What is reduced? So that all patients?
  • Reliably establish the [plasma] - time profile
    • Sample extent
    • Sampling timing
A
  • Receives each drug product only once, with adequate time between medications for the elimination of the drug from the body
  • Is his own control
    • Subject to subject variation is reduced
    • so that all pts do not receive the same drug product on the same day in the same order
  • After each subject receives a drug product, blood samples are collected so that a valid blood drug level-time curve is obtained
  • The time intercals should be spaced so that the peak blood concentratin, the total AUC, and the absorptin elimination phases of the curve may be well described
24
Q

Parameters used to establish a BCS class

3

A
  1. Equilibrium solubility as a function of pH
  2. Permeability measurements with an appropriate biological model
    1. In vivo perfusion studies
    2. In vitro perfusion (tissue)
    3. In vitro cell culture models
  3. Dissolution profile
25
Q

Biopharmaceutical Classification System

Class 1-4

A

Kinetics (6 decks)

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