Trends for Market Access, HEOR, and Real World Evidence Blog マーケットアクセス、医療経済・アウトカム研究 (HEOR)、リアルワールド・エビデンスのトレンド This blog reviews trends for using health economics and outcomes research and real-world evidence to…Certara2019年5月10日
Real World Evidence Marches Forward in Drug Development Blog 医薬品開発での重要性が高まるリアルワールド・エビデンス 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 Publication 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…Jieun Choe2018年6月2日
Model-informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor Publication Model-informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor Danielle Pillsbury2018年2月15日
Drug Asset Evaluation: Increasing “Probability of Success” of a Deal White Paper 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…Danielle Pillsbury2017年8月24日
Model-based Meta-analysis: An Innovative Methodology Comes of Age White Paper モデルに基づくメタ解析(MBMA):革新的な手法の誕生 MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…Danielle Pillsbury2016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 Publication 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…Danielle Pillsbury2016年7月1日
Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis Publication 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…Danielle Pillsbury2015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 Publication 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…Danielle Pillsbury2015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 Publication 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…Danielle Pillsbury2014年10月1日