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Category: Case Study

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

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Pulmonary non-tuberculous mycobacteria (NTM) is a debilitating disease that can lead to reduced lung function and decreased quality of life. The prevalence of NTM infections has been increasing in recent years, particularly in developed countries.1 It is caused by bacteria belonging to the genus Mycobacterium with approximately 80% of NTM infections caused by Mycobacterium avium … Continued

Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease

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Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a variety of generic glucocorticoid steroids (including hydrocortisone, dexamethasone, prednisolone, and prednisone in the US) with no standard treatment regimen. The cortisol deficiency and over-production of male sex hormones caused by CAH can lead to increased mortality, infertility, and sexual development … Continued

Biosimulation Supports Label Claims for a Combination Oncology Treatment

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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

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