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

Adaptive designs for confirmatory clinical trials

Frank Bretz, Franz Koenig, Werner Brannath et al. · Statistics in Medicine · 2009 · 257 citations

Public Health, Biostatistics, Drug Approval Processes +16

Adaptive Dunnett tests for treatment selection

Franz Koenig, Werner Brannath, Frank Bretz et al. · Statistics in Medicine · 2007 · 129 citations

Public Health, Biostatistics, Clinical Data Management +15

Predictors of orphan drug approval in the European Union

Harald E. Heemstra, Remco L. de Vrueh, Sonja van Weely et al. · European Journal of Clinical Pharmacology · 2008 · 53 citations · Full text

Pharmacy, Pharmaceutical Policy, Drug Approval Processes +16

Organizational Scope and Investment: Evidence from the Drug Development Strategies and Performance of Biopharmaceutical Firms

Ilan Guedj, David Scharfstein · SSRN Electronic Journal · 2004 · 52 citations · Full text

Medicine, Finance, Financial Management +15

The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome

Francesco Pignatti, B. Aronsson, Nick Gate et al. · European Journal of Clinical Pharmacology · 2002 · 36 citations

Pharmacy, Regulatory Pharmacy, Drug Approval Processes +6