- Since there is an issue with consent, how are pharmacokinetic studies in healthy pediatric populations approved?
- A company must only study patients who can potentially benefit from treatment. Studies in healthy patients are not permitted. Any child in a clinical trial potentially has to benefit from that trial -- even if it's basic pharmacodynamic, pharmacokinetic blood-draws; there are blood-drawing limits for children as well.
- If a product is to be used only in adults does PREA apply?
- If the product meets the five criteria-- an application for a new indication, new dosage form, new dosing regimen, new route of administration or new active ingredient--then PREA would apply, unless the indication was an orphan indication. The sponsor has a choice of applying for a deferral or waiver of PREA required studies. That waiver can be for the full pediatric age group, or a partial waiver. So PREA does apply, but studies in pediatric patient for adult-only conditions may be waived because of too few patients to study.
- Are children involved in clinical trails for vaccines?
- Yes, however, vaccine legislation is the responsibility of the Center for Biologics Evaluation and Research (CBER). CBER has the leading authority and is a World Health Organization center.
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Topic: page 3 of 4 (Lesson: page 22 of 24)