Real World Evidence Marches Forward in Drug Development
The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm…
Certara2019 年 3 月 20 日
Apixaban for treatment of venous thromboembolism (VTEtx): Use of MBMA to support Phase 3 dose selection and beyond
Apixaban is an orally available, direct, selective inhibitor of the coagulation factor Xa that reversibly…
Certara2018 年 6 月 2 日
Drug Asset Evaluation: Increasing “Probability of Success” of a Deal
Certara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise…
Certara2017 年 8 月 24 日
Model-based Meta-analysis: An Innovative Methodology Comes of Age
MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…
Certara2016 年 7 月 14 日
Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis
The objective of this study was to assess the relationship between short-term and long-term treatment…
Certara2016 年 7 月 1 日
Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis
Gastric emptying (GE) is often reported to be slower and more irregular in premature neonates than…
Certara2015 年 5 月 1 日
A Model-based Dose-response Meta-analysis of Ocular Hypotensive Agents as a Drug Development Tool to Evaluate New Therapies in Glaucoma
PURPOSE: To characterize dose and response for intraocular pressure (IOP) reduction and incidence of hyperemia…
Certara2015 年 5 月 1 日
Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis
Our objective was to compare the time course of bone mineral density (BMD) changes at…
Certara2014 年 10 月 1 日
Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients
Model-based meta-analysis of dose response is a sophisticated method to guide dose and regimen selection.…
Certara2014 年 5 月 21 日
