• Edgar Schuck, Tonika Bohnert, Arijit Chakravarty, Valeriu Damian-Iordache, Christopher Gibson, Cheng-Pang Hsu, Tycho Heimbach, Anu Shilpa Krishnatry, Bianca M Liederer, Jing Lin, Tristan Maurer, Jerome T Mettetal, Daniel R Mudra, Marjoleen Jma Nijsen, Joseph Raybon, Patricia Schroeder, Virna Schuck, Satyendra Suryawanshi, Yaming Su, Patrick Trapa, Alice Tsai, Majid Vakilynejad, Shining Wang, and Harvey Wong.
• Modeling and Simulation, Eisai Inc., 155 Tice Blvd, Woodcliff Lake, NJ, 07677, USA, Edgar_Schuck@eisai.com.
• Aaps J. 2015 Mar 1; 17 (2): 462-73.

AbstractThe application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its broad application. An important goal of preclinical PK/PD analysis in all pharmaceutical companies is for the selection/optimization of doses and/or dose regimens, including prediction of human efficacious doses. Oncology was the therapeutic area with the most PK/PD analysis support and where it showed the most impact. Consistent use of more complex systems pharmacology models and hybrid physiologically based pharmacokinetic models with PK/PD components was less common compared to traditional PK/PD models. Preclinical PK/PD analysis is increasingly being included in regulatory submissions with ~73% of companies including these data to some degree. Most companies (~86%) have seen impact of preclinical PK/PD analyses in drug development. Finally, ~59% of pharmaceutical companies have plans to expand their PK/PD modeling groups over the next 2 years indicating continued growth. The growth of preclinical PK/PD modeling groups in pharmaceutical industry is necessary to establish required resources and skills to further expand use of preclinical PK/PD modeling in a meaningful and impactful manner.

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