Publications by authors named "F Gheyas"
Article Synopsis
- * Enhanced exposure-response and pharmacokinetic/pharmacodynamic modeling revealed that higher concentrations of sotatercept improve key clinical outcomes including 6MWD and the likelihood of achieving lower NT-proBNP levels, while maintaining safety measures like hemoglobin levels.
- * Key factors influencing the treatment's response include patient age and iron supplementation, but their overall impact on outcomes was minimal, supporting the selected dosing strategy of 0.7 mg/kg administered subcutaneously every three weeks as effective and safe.
Population pharmacokinetic modeling of sotatercept in healthy participants and patients with pulmonary arterial hypertension.
CPT Pharmacometrics Syst Pharmacol
August 2024
Article Synopsis
- Sotatercept is a newly FDA-approved biologic for treating pulmonary arterial hypertension (PAH), which shows promising pharmacokinetic (PK) properties based on clinical studies.
- A population pharmacokinetic model was created using data from various studies, analyzing different dosing methods and durations, which included a total of 350 participants.
- The analysis revealed that body weight and a patient's baseline albumin level influence drug clearance and volume but do not significantly affect sotatercept's overall disposition, supporting its use as a subcutaneous treatment for PAH.
A recent industry perspective published in this journal describes the benefits received by drug companies from participation in the MIDD Pilot Program. Along with the primary objectives of supporting good decision-making in drug development, there were substantial savings in time and development costs. Furthermore, many sponsors reported qualitative benefits such as new learnings and clarity on MIDD strategies and methodology that could be applied to other development programs.
View Article and Find Full Text PDFVericiguat, a novel soluble guanylate cyclase (sGC) stimulator, is approved for the treatment of heart failure (HF) with reduced ejection fraction (HFrEF). Decreased nitric oxide (NO) availability, sGC desensitization to NO, sGC deficiency, and reduced cyclic guanosine monophosphate (cGMP) signaling are potential contributing factors for HF disease progression. Vericiguat works via stimulation of sGC in the critical NO-sGC-cGMP pathway.
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