Svensson Lec 7 Flashcards

1
Q

what are the 3 levels of risk-benefit analysis that can occur related to drug therapy?

A

accessibility, acceptability, applicability

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2
Q

what is accessibility?

A

FDA evaluates benefits/risks for the population

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3
Q

what is applicability?

A

Provider evaluates benefits/risks for a patient

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4
Q

what is acceptability?

A

Patient evaluates benefits/risks in terms of personal values

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5
Q

State 3 elements of info needed for application of an investigational new drug with FDA.

A
  1. animal pharmacology and toxicology
  2. manufacturing information
  3. clinical protocol and investigator information
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6
Q

What are the steps to predict the first dose in man for a new drug?

A
  1. Determine NOAEL in appropriate animal species
  2. Calculated human equivalent dose (HED) from appropriate species
  3. Determine a safety factor ( usually 10 )
  4. Divide HED by safety factor to determine max recommended starting dose
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7
Q

what is NOAEL

A
  • no observable adverse effect level
  • highest dose where it has no effect
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8
Q

what is MABEL?

A
  • Minimal anticipated biological effect level
  • Needed to result in biological effect in participants of a clinical trial
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9
Q

Identifying primary reasons adverse drug events are often not detected until after the drug is approved and marketed for a period of time.

A
  1. rare events vs. patient numbers in clinical trails
    –> Only 10,000 or less people studied and sometimes we don’t get information until 100,000s of people
  2. common events vs. patient numbers and duration in clinic trials
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10
Q

Provided key info about potential pharmaceutical excipients determine whether or not preclinical studies are needed in dosage form.

A
  1. GRAS
    - generally recognized as safe
    - a group of compound whose safety in humans has been established through careful studies or widespread use
    - if included in a drug formulation as excipients, specific toxicology data is not needed for those compounds
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11
Q

Name 5 categories of preclinical studies completed for new drug development.

A
  1. acute studies
  2. repeated dose studies
  3. genetic toxicity
  4. reproductive toxicity
  5. carcinogenicity
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12
Q

what are acute studies?

A
  • effect of single dose
  • at least 2 species
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13
Q

what are repeated dose studies?

A
  • length depends on anticipated therapy
  • at least 2 species
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14
Q

what is genetic toxicity?

A
  • determine likelihood compound is mutagenic or carcinogenic
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15
Q

what is reproductive toxicity?

A
  • needs depends on target population
  • multiple species
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16
Q

what is carcinogenicity?

A
  • only for compounds used in chronic or recurring conditions