Pediatrics Archives

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

Case Study

Simcypの年齢定義機能により、新生児へのエベロリムス投与が容易に

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

Jim Gallagher2021年8月26日

Case Study

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

Jim Gallagher2021年8月20日

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

Case Study

鎌状赤血球症治療用のVoxelotor：用量予測モデルを活用して臨床試験を実施することなくDDIを予測

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

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…

Jim Gallagher2021年4月20日

White Paper

Simcyp PBPK を用いた小児用医薬品開発の促進

Jim Gallagher2021年3月4日

Case Study

ガルデルマ社、AKLIEF®（トリファロテン）のFDA承認を取得

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…

Certara2020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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小児

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Simcypの年齢定義機能により、新生児へのエベロリムス投与が容易に

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

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

鎌状赤血球症治療用のVoxelotor：用量予測モデルを活用して臨床試験を実施することなくDDIを予測

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

Simcyp PBPK を用いた小児用医薬品開発の促進

ガルデルマ社、AKLIEF®（トリファロテン）のFDA承認を取得

The Research to Accelerate Cures and Equity (RACE) for Children Act: Changing the Landscape of Pediatric Cancer Drug Development

Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110

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