Spiros Vamvakas

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

Frank Dieterle, Frank D. Sistare, Federico Goodsaid et al. · Nature Biotechnology · 2010 · 403 citations

Translational Medicine, Urology, Renal Function +9

Clinical Outcome Assessments: Conceptual Foundation—Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force

Marc K. Walton, John H. Powers, Jeremy Hobart et al. · Value in Health · 2015 · 301 citations · Full text

Clinical Effectiveness, Health Policy, Clinical Endpoint +12

From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients

H‐G Eichler, LG Baird, Richard Barker et al. · Clinical Pharmacology & Therapeutics · 2015 · 184 citations · Full text

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

John H. Powers, Donald L. Patrick, Marc K. Walton et al. · Value in Health · 2017 · 155 citations · Full text

Program Implementation, Health Policy, Clinical Effectiveness +13

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency

Jan Regnström, Franz Koenig, B. Aronsson et al. · European Journal of Clinical Pharmacology · 2009 · 123 citations · Full text

European Medicines Agency, Health Economics, Market Authorisation Applications +9