Modeling and Simulation (M&S) can be a key factor in efficient drug development. It is well recognized that collaboration of multiple disciplines is critical to the success of M&S in supporting drug development decisions. This chapter provides guidance on how the main collaborators (biostatistics, clinical research and clinical PK-PD) can achieve co-ownership of M&S efforts to make better informed decisions on trial designs. The clinical development program of corifollitropin alfa is presented as an example of successful model-based drug development. Throughout a long-lasting collaborative effort, biostatistics and clinical PK-PD scientists have learned to appreciate each other's methods, all collaborators have shared their expertise to integrate physiological and pharmacological concepts with clinical data and clinical research has started to pro-actively conduct model-informed trials. Cultural barriers and logistical difficulties were overcome, resulting in an organizational structure that ensures better informed decisions on trial designs and more efficient drug development. © American Association of Pharmaceutical Scientists 2011.
CITATION STYLE
Zandvliet, A. S., de Greef, R., de Haan, A. F. J., Ijzerman-Boon, P. C., Marintcheva-Petrova, M. Z., Mannaerts, B. M. J. L., & Kerbusch, T. (2011). Keys of collaboration to enhance efficiency and impact of modeling and simulation. AAPS Advances in the Pharmaceutical Sciences Series, 2011(1), 131–148. https://doi.org/10.1007/978-1-4419-7415-0_7
Mendeley helps you to discover research relevant for your work.