ArticleThe AAPS journal2015
Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.
Article in The AAPS journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
15 citing papers in PubMed, 51 citations in OpenAlex.
- Review
- Application of machine learning in combination with mechanistic modeling to predict plasma exposure of small molecules.Frontiers in systems biology · 2023Article
- Clinical significance of the rivaroxaban-dronedarone interaction: insights from physiologically based pharmacokinetic modelling.European heart journal open · 2023Review
- Preclinical Pharmacokinetic and Pharmacodynamic Investigation of 5'-Methoxynobiletin from Ageratum conyzoides: In vivo and In silico Approaches.Pharmaceutical research · 2022Article
- Exposure-response modeling improves selection of radiation and radiosensitizer combinations.Journal of pharmacokinetics and pharmacodynamics · 2022Article
- Pharmacokinetic-pharmacodynamic modelling of the anti-FcRn monoclonal antibody rozanolixizumab: Translation from preclinical stages to the clinic.CPT: pharmacometrics & systems pharmacology · 2022Article
- Matrix Effects of the Hydroethanolic Extract of Calyces ofPharmaceutics · 2021Article
- Mechanistic Multilayer Quantitative Model for Nonlinear Pharmacokinetics, Target Occupancy and Pharmacodynamics (PK/TO/PD) Relationship of D-Amino Acid Oxidase Inhibitor, TAK-831 in Mice.Pharmaceutical research · 2020Article
- A review of three years' experience of the first pharmacometrics company in Korea.Translational and clinical pharmacology · 2019Article
- Predicting and Understanding the Human Microbiome's Impact on Pharmacology.Trends in pharmacological sciences · 2019Review
- A Survey of Software Tool Utilization and Capabilities for Quantitative Systems Pharmacology: What We Have and What We Need.CPT: pharmacometrics & systems pharmacology · 2019Article
- Preclinical QSP Modeling in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape.CPT: pharmacometrics & systems pharmacology · 2018Review
- Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.Regulatory toxicology and pharmacology : RTP · 2017Article
- A Tutorial on Pharmacodynamic Scripting Facility in Simcyp.CPT: pharmacometrics & systems pharmacology · 2016Article
- Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance.Current pharmacology reportsReview
Corrections and comments
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Authors and funding
24 authors at 19 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.