title: Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.
abstract: The 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.
authors: Modeling and Simulation, Eisai Inc., 155 Tice Blvd, Woodcliff Lake, NJ, 07677, USA, Edgar_Schuck@eisai.com.
authors: Edgar
authors: E
authors: Schuck
authors: Tonika
authors: T
authors: Bohnert
authors: Arijit
authors: A
authors: Chakravarty
authors: Valeriu
authors: V
authors: Damian-Iordache
authors: Christopher
authors: C
authors: Gibson
authors: Cheng-Pang
authors: CP
authors: Hsu
authors: Tycho
authors: T
authors: Heimbach
authors: Anu Shilpa
authors: AS
authors: Krishnatry
authors: Bianca M
authors: BM
authors: Liederer
authors: Jing
authors: J
authors: Lin
authors: Tristan
authors: T
authors: Maurer
authors: Jerome T
authors: JT
authors: Mettetal
authors: Daniel R
authors: DR
authors: Mudra
authors: Marjoleen Jma
authors: MJ
authors: Nijsen
authors: Joseph
authors: J
authors: Raybon
authors: Patricia
authors: P
authors: Schroeder
authors: Virna
authors: V
authors: Schuck
authors: Satyendra
authors: S
authors: Suryawanshi
authors: Yaming
authors: Y
authors: Su
authors: Patrick
authors: P
authors: Trapa
authors: Alice
authors: A
authors: Tsai
authors: Majid
authors: M
authors: Vakilynejad
authors: Shining
authors: S
authors: Wang
authors: Harvey
authors: H
authors: Wong
mesh_terms: D003198:Computer Simulation; D003625:Data Collection; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D055808:Drug Discovery / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004345:Drug Industry / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D008954:Models, Biological
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