Persistent Pulmonary Hypertension of the Newborn - Mattel ...
Persistent Pulmonary Hypertension of the Newborn - Mattel ...
Persistent Pulmonary Hypertension of the Newborn - Mattel ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Off Label Drug Use• New uses, doses, or indications will not beapproved by <strong>the</strong> FDA until substantial evidence<strong>of</strong> safety and effectiveness – years, never??• Ethical & safety challenges• Neonates are constantly undergoing maturation –alter pharmacokinetics & end-organ responses• Therefore, clinical trials in adults or older childrencannot predict pharmacokinetics & end-organresponses <strong>of</strong> neonates