Category: 事例
Using Real Word Evidence to Enhance Drug Development
パンデミック時のウイルス感染に対するモノクローナル抗体治療、予防、ワクチンの影響を予測するエージェントベースのモデル
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
チームの絆を向上させると同時に24時間対応可能な規制対応サポート
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.
希少疾患からの臨床データを活用して、他の疾患の医薬品承認をサポート
出典非定型溶血性尿毒症症候群（aHUS）は、全身の細い血管に異常な血栓形成を引き起こし、腎不全、他の臓器障害、早死にを引き起こす超希少な遺伝病です。このプロジェクトの開始時点では、FDAが承認したaHUSの治療法はありませんでした。Furthermore, as only a few thousand aHUS patients are diagnosed … Continued
