ICH M12 Guidelines & Your Drug-Drug Interaction Package Blog ICH M12ガイドラインと薬物相互作用評価パッケージの整備について We have provided an overview of the key changes to the ICH M12 drug-drug interaction…Certara2024年6月19日
Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator Publication Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation.…Certara2024年2月23日
PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA Case Study PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…Certara2022年6月2日
PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials Case Study PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…Certara2022年4月11日
Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Case Study Simcyp Simulator を使用した小児における Guanfacine の DDI 責任の判定 Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…Certara2021年8月26日
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…Certara2021年8月26日
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…Certara2021年8月12日
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Case Study PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…Certara2021年8月12日
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study Simcyp Simulatorを使用するDDIレギュレトリーの広告塔:Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…Certara2021年7月29日
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies 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…Certara2021年7月14日