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Tag: Model-Based Meta-Analysis (MBMA)

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

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New therapeutics discovery and development for ocular diseases have been traditionally associated with a low probability of technical and regulatory success. The significant unmet medical needs for ocular diseases include but aren’t limited to glaucoma, age-related macular degeneration, and retinopathy. Recently, there has also been considerable focus on thyroid eye disease (TED). This research gained … Continued

Model-based meta-analysis for comparative efficacy and safety of therapeutics for COVID-19

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Certara is launching the COVID-19 Clinical Outcomes Database, funded by the COVID-19 Therapeutics Accelerator. The Database includes observational studies and clinical trials with more than 10 patients that evaluate specific treatment options to improve disease outcome. It captures all patient characteristics, safety and efficacy outcomes, biomarkers and viral load data. The database also includes studies (>100 patients) that evaluate patient characteristics stratified by disease outcome such as death, or progression to severe or critical disease and studies (>10 patients) that report the time course of viral load, vital signs, and biomarkers.

腫瘍薬開発と患者アクセスの枠組みを変革する

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Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.

Apixaban for treatment of venous thromboembolism (VTEtx): Use of MBMA to support Phase 3 dose selection and beyond

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Apixaban is an orally available, direct, selective inhibitor of the coagulation factor Xa that reversibly binds to the active site of FXa, and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. Apixaban is approved in multiple regions for VTEtx, based on the results of a Phase 3 study (AMPLIFY [1]). … Continued

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