Using Real Word Evidence to Enhance Drug Development
Real-world evidence (RWE) has emerged as an increasingly important tool in the drug development process,1…
Danielle Pillsbury2023年4月5日
Agent-Based Model Predicts Impact of Monoclonal Antibody Treatment, Prophylaxis & Vaccines on Viral Transmission during Pandemic
Agent-based models focus on the heterogeneous behavior of individual agents and their interactions with one…
Danielle Pillsbury2023年3月2日
Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer
Bispecific antibodies are an emerging class of antibodies developed in recent years that provide new…
Danielle Pillsbury2023年1月23日
Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy
Olanzapine is an effective antipsychotic medication used to treat schizophrenia, a disease that affects about…
Jim Gallagher2022年10月31日
Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease
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。Current therapy for CAH uses a…
Becca Bucci2022年6月6日
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…
Becca Bucci2022年6月3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…
Becca Bucci2022年6月2日
Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another
Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot…
Becca Bucci2022年6月1日
PK Modeling Supports Dosing Strategy for Patients with Hepatic Impairment
Primary biliary cholangitis (PBC) is a chronic disease that impedes bile flow from the liver,…
Becca Bucci2022年5月31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…
Jim Gallagher2022年4月11日
