Integrating In Vitro Systems and Physiologically-Based Pharmacokinetics Modeling to Optimize Drug Development
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmacokinetics and Pharmacodynamics".
Deadline for manuscript submissions: closed (30 December 2021)
Special Issue Editor
Interests: 1. Integrating in vitro systems and quantitative methods and modeling to inform drug discovery and drug product development with focus on: a. Mechanistic absorption models; b. Translational DMPK, c. Disease-based models; 2. Integrating stem cell technology, tissue biopsy, co-culture techniques, microfluidics, and next-generation sequencing to develop microphysiological systems to investigate drug- and disease-related mechanisms affecting membrane integrity and predict drug absorption/disposition: a. Development of a segment-specific intestine-on-a-chip to investigate drug- and disease-related mechanism affecting intestinal membrane integrity (leaky gut), as well as transport-mediated kinetics and drug–drug interactions; b. development of a neurovascular unit-on-a-chip model to study drug penetration in the brain parenchyma and cerebrospinal fluid, as well as molecular and cellular underlying mechanisms in neurodegenerative diseases
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Special Issue Information
Dear Colleagues,
Physiologically-based pharmacokinetic (PBPK) modeling and simulation have been used to combine drug independent biological and physiological information regarding the system (animal or human body under healthy or disease condition) with drug- and formulation-specific properties. Advances in the in vitro drug and formulation characterization provides measurements that are critical inputs into the models. The greater connectivity between in vitro–in vivo extrapolation (IVIVE) techniques and PBPK to predict and define population variability in drug absorption, distribution, metabolism, and excretion (ADME) is a key factor in its applicability in advancing drug and formulation development under the overarching umbrella of regulatory science. In this context, in vivo predictive dissolution and microphysiological systems can be viewed as innovative technologies, with a unique potential to provide refined tools to establish input parameters that form the foundation of PBPK model. As in vitro systems become more advanced, we will likely see more integration with model-informed drug development approaches for better understanding of drug release and disposition under a plethora of (patho)physiologically-relevant conditions, designing clinical trials, and, ultimately, better individualized patient treatment.
Dr. Rodrigo Cristofoletti
Guest Editor
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Keywords
- PBPK
- IVIVE
- microphysiological system
- organ-on-a-chip
- biorelevant dissolution
- quantitative clinical pharmacology
