Simcyp-led Linked-in Live Event Draws Hundreds of Registrants
Simcyp led a panel discussion on the benefits of using physiologically-based pharmacokinetic modeling & simulation for 2 vulnerable populations—pregnancy and pediatrics.
Tag: 小児
Simcyp Simulatorが希少疾患の成人および青少年における薬物投与の最適化を支援
先天性副腎過形成症（CAH）は、世界中でおよそ400,000人の患者さんがいます。CAHに対する現在の治療では、標準的な治療レジメンはなく、さまざまな汎用グルココルチコイドステロイド（米国ではヒドロコルチゾン、デキサメタゾン、プレドニゾロン、プレドニゾンなど）が使用されています。The cortisol deficiency and over-production of male sex hormones caused by CAH can lead to increased mortality, infertility, and sexual development … Continued
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 treat SMA in patients ≥2 months old, followed by the European Medicine Agency. Risdiplam addresses the underlying cause of SMA: a reduced amount of survival motor neuron (SMN) protein.
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 treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD). Guanfacine is primarily metabolized by the CYP3A4 enzyme. Thus, it was important to evaluate the drug-drug interaction (DDI) liability perpetrated by strong inhibitors and inducers of CYP3A4. Using data from … Continued
Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates
Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder
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 in ages 2 and older. Unlike many other therapies for treating TSC-associated seizures, everolimus addresses the underlying pathophysiology of TSC. As TSC-associated seizures can also affect children aged between 6 months and 2 years, a modeling and simulation approach that … Continued
Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy
Certara to Host Inaugural Symposium Dedicated to Advancing Pediatric Drug Development
ニュージャージー州プリンストン 2021年8月4日: Certara, the global leader in biosimulation, today announced it will host the inaugural New Horizons in Pediatric Drug Development Symposium taking place October 28-29, 2021. The two-day virtual symposium is being held to bring together thought leaders and innovators in pediatric drug development to share new developments in the field … Continued
