Preclinical Pharmacokinetic/Pharmacodynamic Modeling and Simulation in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 2
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 and Affiliations
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, Harvey Wong
Keywords
Related Articles
- EP ID EP680933
- DOI 10.1208/s12248-014-9716-2
- Views 67
- Downloads 0
Comparative In Silico–In Vivo Evaluation of ASGP-R Ligands for Hepatic Targeting of Curcumin Gantrez Nanoparticles
The online version of this article (doi:10.1208/s12248-013-9474-6) contains supplementary material, which is available to authorized users.
Near-Infrared Investigations of Novel Anti-HIV Tenofovir Liposomes
Near-infrared (NIR) approaches is considered one of the most well-studied process analyzers evolving from the process analytical technology initiatives. The objective of this study was to evaluate NIR spectroscopy and im...
Prediction of dissolution-absorption relationships from a continuous dissolution/Caco-2 system
The objectives were 1) to design a continuous dissolution Caco-2 system to predict the dissolution-absorption relationships for fast and slow dissolving formulations of piroxicam, metoprolol tartrate, and ranitidine HCl,...
Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
The L1 Global Harmonization Team provides recommendations specifically for run acceptance of ligand binding methods used in bioanalysis of macromolecules in support of pharmacokinetics. The team focused on standard curve...
Inhibitors of the FcRn:IgG Protein–Protein Interaction
The neonatal Fc receptor, FcRn, is responsible for controlling the half-life of IgG antibodies. As a result, inhibitors of FcRn have been investigated as a possible way to modulate IgG half-lives. Such inhibitors could h...