Case Study

Advancing Pediatric Drug Development Using Simcyp PBPK

Advancing Pediatric Drug Development Using Simcyp PBPK

Advancing Pediatric Drug Development Using Simcyp PBPK Case studies for neonate/child dosing, drugs for children’s diseases, DDIs for pediatrics, and developing child-specific formulations Dr. Karen Rowland Yeo, Sr VP of Client and Regulatory Strategy Trevor Johnson, PhD, Principal Scientist2 Case studies for neonate/child dosing, drugs for children’s diseases, DDIs for pediatrics, and developing child-specific formulations After many years of encouragement and soft incentives, it is now a legal requirement for drug companies to develop medicines for children. Bolstering this regulatory initiative is an extra six months of patent protection provided to companies that develop and provide drugs for pediatric populations. In the US and EU, pediatric study (PSP) or investigation p

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