ICH M12 Guidelines & Your Drug-Drug Interaction Package
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
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
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
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
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
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
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
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®)
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
In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…
Certara2021 年 7 月 14 日
