Pediatric Patients in Drug Development
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Questions and Answers

What term did Shirkey use to refer to pediatric patients in 1968?

  • Treatment exiles
  • Pharmacological outcasts
  • Medical misfits
  • Therapeutic orphans (correct)

Why were pediatric patients referred to as 'therapeutic orphans'?

  • Because they were abandoned by the medical community
  • As they were resistant to drug treatments
  • For being hard to diagnose correctly
  • Due to differences in drug metabolism in children compared to adults (correct)

At what age do some drugs show a decreased clearance in neonates and infants?

  • 1-3 years of age
  • Up to 2 months of age (correct)
  • 6-12 months of age
  • 2-6 months of age

Which phase of hepatic drug metabolism at birth is 30% that of adults?

<p>Phase I (B)</p> Signup and view all the answers

When does phase I metabolic capacity in children trend toward adult levels?

<p>By early puberty (D)</p> Signup and view all the answers

How does children having less acidic stomach contents impact drug absorption?

<p>It increases absorption of acid drugs (D)</p> Signup and view all the answers

What factor contributes to infants experiencing increased levels of active drug in the circulation?

<p>Lower levels of serum albumin (C)</p> Signup and view all the answers

Why is there a lack of research in pediatric pharmacology according to the text?

<p>Ethical concerns related to conducting studies on children (A)</p> Signup and view all the answers

What are the main limitations to undertaking pharmacokinetic studies in newborns and infants as mentioned in the text?

<p>Blood collection challenges (B)</p> Signup and view all the answers

How do current guidelines suggest using data obtained from adults in pediatric clinical trials?

<p>Encourage extrapolation from adult data to children when appropriate (B)</p> Signup and view all the answers
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