Simcyp-led Linked-in Live Event Draws Hundreds of Registrants
Simcyp led a panel discussion on the benefits of using physiologically-based pharmacokinetic modeling & simulation for 2 vulnerable populations—pregnancy and pediatrics.
Tag: PBPK
将 PBPK 模型应用于儿科药物开发的最佳实践框架
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
利用基因治疗虚拟双胞胎平台优化剂量
This blog explains how using the Gene Therapy Virtual Twin™ Platform can help optimize dosing for patients.
虚拟双胞胎患者可以弥合因新冠肺炎暂停的临床试验的数据空白
The virtual twin approach combines limited clinical data with biological principles to make patient level predictions which could help recover halted trials.
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