Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates Case Study Simcyp 年龄定义功能助力优化新生儿 Everolimus 给药方案 Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…Certara2021 年 8 月 26 日
Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Case Study Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Certara2021 年 8 月 20 日
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta Case Study Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…Certara2021 年 7 月 14 日
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Case Study 治疗镰状细胞病的 Voxelotor:无需任何临床研究,利用剂量预测模型进行 DDI 预测 In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…Certara2021 年 7 月 14 日
A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development On-Demand Webinar 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…Certara2021 年 4 月 20 日
Advancing Pediatric Drug Development Using Simcyp® PBPK White Paper 利用 Simcyp® PBPK 推进儿科药物研发 Certara2021 年 3 月 4 日
Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Case Study Galderma AKLIEF®(曲法罗汀)获得了 FDA 批准 In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…Certara2020 年 11 月 9 日
The research to accelerate cures and equity (RACE) for children act: Changing the landscape of pediatric cancer drug development Blog The research to accelerate cures and equity (RACE) for children act: Changing the landscape of pediatric cancer drug development 3 key tips to set your pediatric program up for success with the RACE for…Certara2020 年 7 月 14 日
Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110 Publication Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110 Certara2020 年 1 月 17 日
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing Publication Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal DosingCertara2020 年 1 月 17 日