ACTUAL EXAM COMPLETE ACCURATE
EXAM QUESTIONS WITH DETAILED
VERIFIED ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
True or False- All new medications should
have generated data on the use in the
pediatric population? - ....ANSWER...False
True or False- Medicinal products may
affect physical and cognitive growth and
development: and the adverse event profile
may differ in pediatric patients. -
....ANSWER...True
,What is it called when a child is given
information about a trial and asked if he or
she wishes to participate? -
....ANSWER...Assent
T or F- Although initial safety and
tolerability data is usually obtained in adult
trials: some products may reasonably be
studied only in the pediatric population
even in the initial phases (e.g.: when
studies in adults would yield little useful
information or expose them to inappropriate
risk). -
....ANSWER...True
T or F- Pharmacokinetic Phase 1 studies in
the pediatric population are generally
conducted in healthy pediatric subjects. -
....ANSWER...False
T or F- Pharmacokinetic studies in the
pediatric population are generally
conducted in patients with the disease. -
....ANSWER...True
,The two ways to minimize the number of
samples obtained from each pediatric
patient are -
....ANSWER...1. Population PK & Sparse
sampling
2. Use of indwelling catheters
, T or F- It is common to extrapolate efficacy
from studies in adults or even in older
pediatric patients to the preterm newborn
infant to decrease the amount of blood
taken. - ....ANSWER...False
The current protocol for a study in
pediatrics is asking for all new patients to
have stages of pubertal development
assessed. This assessment is called -
....ANSWER...Tanner Staging
You are reading a Phase 2 protocol: which
uses pharmacokinetic sampling in a
pediatric population with Sickle Cell
Disease. Which of the following options may
be true in this scenario? - ....ANSWER...1.
The data may better reflect clinical use
2. This may lead to higher inter subject
variability
Dosing recommendations for most medicinal
products used in the pediatric population
are usually based on ________________