Most downloaded papers in 2023

Articles (5 in this collection)

1. Risk-Based Monitoring in Clinical Trials: 2021 Update

   Authors (first, second and last of 13)

   • Amy Adams
   • Anina Adelfio
   • Debby Brown

   • Content type: Analytical Report
   • Open Access
   • Published: 09 January 2023

   • Pages: 529 - 537

   

2. Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries

   Authors (first, second and last of 5)

   • Pedro Franco
   • Ritesh Jain
   • Marén U. Koban

   • Content type: Review
   • Open Access
   • Published: 03 December 2022

   • Pages: 484 - 514

3. Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors

   Authors (first, second and last of 4)

   • Daniel Tobias Michaeli
   • Hasan Basri Yagmur
   • Thomas Michaeli

   • Content type: Original Research
   • Open Access
   • Published: 11 January 2022

   • Pages: 313 - 322

   

4. Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation])

   Authors (first, second and last of 6)

   • Folker Spitzenberger
   • Jaimin Patel
   • Christian Meisel

   • Content type: Original Research
   • Open Access
   • Published: 21 July 2021

   • Pages: 47 - 64

   

5. Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019

   Authors (first, second and last of 4)

   • Judith P. ter Horst
   • Sada L. Turimella
   • Alex Zwiers

   • Content type: Original Research
   • Open Access
   • Published: 13 January 2021

   • Pages: 583 - 590