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A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimise and replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidances on paediatrics. Best practice standards were … Continued

Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure

The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions).  Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.  Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of … Continued

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