Corpus ID: 57326099

The Role of PK/PD Modeling and Simulation in Model-based New Drug Development

  title={The Role of PK/PD Modeling and Simulation in Model-based New Drug Development},
  author={Hwi-yeol Yun and In-hwan Baek and Jeong-won Seo and Kyung-jin Bae and Mann-Hyung Lee and Wonku Kang and Kwang-il Kwon},
In the recent, pharmacokinetic(PK)/pharmacodynamic(PD) modeling has appeared as a critical path tools in new drug development to optimize drug efficacy and safety. PK/PD modeling is the mathematical approaches of the relationships between PK and PD. This approach in new drug development can be estimated inaccessible PK and PD parameters, evaluated competing hypothesis, and predicted the response under new conditions. Additionally, PK/PD modeling provides the information about systemic… Expand
1 Citations
Influence of Oxygen to Population Pharmacokinetics/Pharmacodynamics of Alcohol in Healthy Volunteers
Influence of Oxygen to Population Pharmacokinetics/Pharmacodynamics of Alcohol in Healthy Volunteers and Drug development center Department of pharmacy, Chungnam National University, Daejeon 34134. Expand


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Mechanism-based pharmacokinetic-pharmacodynamic modeling: biophase distribution, receptor theory, and dynamical systems analysis.
This work focuses on mechanism-based PK-PD models, which constitute a theoretical basis for rational drug discovery and development and contain specific expressions to characterize, in a quantitative manner, processes on the causal path between drug administration and effect. Expand
Quantitative structure-pharmacokinetic/pharmacodynamic relationships.
  • D. Mager
  • Biology, Medicine
  • Advanced drug delivery reviews
  • 2006
Traditional and contemporary approaches to developing QSPKR models are discussed, along with selected examples of attempts to couple QSP KR and pharmacodynamic models to anticipate the intensity and time-course of the pharmacological effects of new or related compounds, or quantitative structure-pharmacodynamic relationships modeling. Expand
Methodological Issues in Pharmacokinetic-Pharmacodynamic Modelling
Theoretical and practical aspects involved in the design and analysis of pharmacokinetic-pharmacodynamic modelling studies are presented, along with the way pharmacodynamic models and methods of estimation can be applied to real data and the information required to criticise the results of modelling. Expand
Comparison of four basic models of indirect pharmacodynamic responses
Four basic models for characterizing indirect pharmacodynamic responses after drug administration have been developed and compared and it was found that the responses produced showed a slow onset and a slow return to baseline. Expand
Diversity of mechanism-based pharmacodynamic models.
  • D. Mager, E. Wyska, W. Jusko
  • Computer Science, Medicine
  • Drug metabolism and disposition: the biological fate of chemicals
  • 2003
The purpose of this article is to describe the classic as well as contemporary approaches to pharmacodynamic modeling, with an emphasis on pertinent equations and salient model features. Expand
Characteristics of indirect pharmacodynamic models and applications to clinical drug responses.
This review describes four basic physiologic indirect pharmacodynamic response (IDR) models which have been proposed to characterize the pharmacodynamics of drugs that act by indirect mechanisms suchExpand
Optimizing the Use of Biomarkers, Surrogate Endpoints, and Clinical Endpoints for More Efficient Drug Development
  • W. Colburn
  • Medicine
  • Journal of clinical pharmacology
  • 2000
Biomarkers and surrogate endpoints are critical to the future of efficient drug development. Definitions, a conceptual model, and a conceptual framework for validating and bridging biomarkers toExpand
Precursor-dependent indirect pharmacodynamic response model for tolerance and rebound phenomena.
A precursor-dependent model of indirect pharmacodynamic response which can describe tolerance and rebound was characterized in terms of the effects of changes in the fundamental properties of the drug on its response profiles, and the response patterns demonstrated may be helpful in describingolerance and rebound phenomena for drugs which affect precursor pools. Expand
Assessment of Basic Indirect Pharmacodynamic Response Models with Physiological Limits
Simulations reveal that the expanded IDRPL models exhibit most properties of basic indirect response models, such as slow response initiation, lag time between the kinetic and dynamic peaks, a large dose plateau, and shift in Tmax with dose. Expand