Pediatric Patients in Drug Development

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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?

Phase I Signup and view all the answers

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

By early puberty Signup and view all the answers

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

It increases absorption of acid drugs Signup and view all the answers

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

Lower levels of serum albumin Signup and view all the answers

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

Ethical concerns related to conducting studies on children Signup and view all the answers

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

Blood collection challenges Signup and view all the answers

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

Encourage extrapolation from adult data to children when appropriate Signup and view all the answers

Pediatric Patients in Drug Development

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Questions and Answers

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

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

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

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

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

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

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

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

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

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

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