Role of Quantitative Clinical Pharmacology in Guiding Drug
Role of Quantitative Clinical Pharmacology in Guiding Drug
Role of Quantitative Clinical Pharmacology in Guiding Drug
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The Issue<br />
• Argatroban, a direct thromb<strong>in</strong> <strong>in</strong>hibitor - approved<br />
for Hepar<strong>in</strong> Induced Thrombocytopenia (HIT) <strong>in</strong><br />
Adults<br />
• Sponsor sought pediatric exclusivity based on a<br />
PK/PD study <strong>in</strong> 15 critically ill pediatric patients<br />
with HIT/HITTS (frequency ~1 - 2%) across the age<br />
ranges <strong>of</strong> < 6 months and up to 8-16 years old<br />
• Study took 4 years and still could not meet the<br />
orig<strong>in</strong>al goal <strong>of</strong> 24 pediatric patient data<br />
• Can we derive useful <strong>in</strong>formation from the exist<strong>in</strong>g<br />
data or should we wait to meet the goal <strong>in</strong> the face<br />
<strong>of</strong> challeng<strong>in</strong>g recruitment and delay <strong>in</strong> patient<br />
access to the treatment?<br />
September 24-25, 2009 OCP Ambassador Program Nit<strong>in</strong>.Mehrotra@fda.hhs.gov 16
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