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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CTS Allowed <strong>Quantitative</strong> Evaluation <strong>of</strong>…<br />
• Consequences <strong>of</strong> pediatric patients be<strong>in</strong>g less responsive<br />
and less sensitive compared to adult patients<br />
• Impact <strong>of</strong> patients drop-out and the choice <strong>of</strong> powerful<br />
statistical method for primary analysis.<br />
• Factors, such as differences between adult and pediatric<br />
population, the choice <strong>of</strong> primary endpo<strong>in</strong>t and dose<br />
selection, affect<strong>in</strong>g the success <strong>of</strong> a given study<br />
More importantly, it allowed several discipl<strong>in</strong>es to<br />
have objective discussion on each <strong>of</strong> the above areas<br />
September 24-25, 2009 OCP Ambassador Program Nit<strong>in</strong>.Mehrotra@fda.hhs.gov 31
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