Category: 案例研究
Using Real Word Evidence to Enhance Drug Development
基于主体的模型可预测大流行期间单克隆抗体治疗、预防和疫苗对病毒传播的影响
Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer
Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy
Simcyp Simulator 有助于优化成人和青少年孤儿病患者的用药剂量
全世界约有 400,000 名先天性肾上腺增生症（CAH）患者。目前治疗 CAH 的方法是使用各种普通糖皮质激素类固醇（在美国包括 hydrocortisone, dexamethasone, prednisolone 和 prednisone），没有标准的治疗方案。The cortisol deficiency and over-production of male sex hormones caused by CAH can lead to increased mortality, infertility, and sexual development … Continued
提供全天候监管支持，同时提升团队凝聚力
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a technology platform which uses engineered Listeria monocytogenes. The company is headquartered in Monmouth Junction, New Jersey.
Biosimulation Supports Label Claims for a Combination Oncology Treatment
Genentech’s Zelboraf® (vemurafenib) is a small molecule B-RAF inhibitor and is FDA-approved to treat patients with metastatic or unresectable melanoma whose tumors express the B-RAF V600E mutation. To reduce the likelihood of cancer cells becoming drug resistant, Genentech wanted to combine vemurafenib with cobimetinib, a small molecule MEK inhibitor that targeted a different part of … 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.
利用一种罕见病的临床数据支持另一种罕见病的药物审批
非典型溶血性尿毒症综合征（aHUS）是一种极其罕见的遗传疾病，会导致全身小血管内异常血凝块的形成，从而导致肾衰竭、其他器官损伤和过早死亡。在项目开始时，美国食品及药物管理局尚未批准治疗 aHUS 的药物。Furthermore, as only a few thousand aHUS patients are diagnosed … Continued
