Pediatrics Archives | 第 2 页，共 6 页 | Certara

AstraZeneca

Case Study

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to…

Jim Gallagher2021 年 8 月 26 日

Novartis

Case Study

Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates

Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…

Jim Gallagher2021 年 8 月 26 日

PTC Therapeutics

Case Study

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Jim Gallagher2021 年 8 月 20 日

Vertex

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…

Jim Gallagher2021 年 7 月 14 日

GBT

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…

Jim Gallagher2021 年 7 月 14 日

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…

Jim Gallagher2021 年 4 月 20 日

White Paper

应用 Simcyp™ PBPK 技术推进儿科药物研发

Jim Gallagher2021 年 3 月 4 日

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

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…

Lynne Georgopoulos, RN, MSHS, RAC2020 年 7 月 14 日

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

webdev2020 年 1 月 17 日

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