Physiologically Based Pharmacokinetic (PBPK) Modeling Books

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Physiologically Based Pharmacokinetic PBPK Modeling and Simulations


Physiologically Based Pharmacokinetic  PBPK  Modeling and Simulations
  • Author : Sheila Annie Peters
  • Publisher : John Wiley & Sons
  • Release : 2012-02-17
  • ISBN : 9781118140307
  • Language : En, Es, Fr & De
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The only book dedicated to physiologically-based pharmacokineticmodeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has becomeincreasingly widespread within the pharmaceutical industry over thelast decade, but without one dedicated book that provides theinformation researchers need to learn these new techniques, itsapplications are severely limited. Describing the principles,methods, and applications of PBPK modeling as used inpharmaceutics, Physiologically-Based Pharmacokinetic (PBPK)Modeling and Simulations fills this void. Connecting theory with practice, the book explores theincredible potential of PBPK modeling for improving drug discoveryand development. Comprised of two parts, the book first provides adetailed and systematic treatment of the principles behindphysiological modeling of pharmacokinetic processes,inter-individual variability, and drug interactions for smallmolecule drugs and biologics. The second part looks in greaterdetail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for abrief overview of the field as well as those who need more detail,the book includes a range of important learning aids. Featuringend-of-chapter keywords for easy reference—a valuable assetfor general or novice readers without a PBPK background—alongwith an extensive bibliography for those looking for furtherinformation, Physiologically- Based Pharmacokinetic (PBPK) Modelingand Simulations is the essential single-volume text on one of thehottest topics in the pharmaceutical sciences today.

Physiologically Based Pharmacokinetic PBPK Modeling


Physiologically Based Pharmacokinetic  PBPK  Modeling
  • Author : Jeffrey W. Fisher
  • Publisher : Academic Press
  • Release : 2020-05-20
  • ISBN : 9780128196823
  • Language : En, Es, Fr & De
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Physiologically Based Pharmacokinetic (PBPK) Modeling: Methods and Applications in Toxicology and Risk Assessment presents foundational principles, advanced techniques and applications of PBPK modeling. Contributions from experts in PBPK modeling cover topics such as pharmacokinetic principles, classical physiological models, the application of physiological models for dose-response and risk assessment, the use of in vitro information, and in silico methods. With end-of-chapter exercises that allow readers to practice and learn the skills associated with PBPK modeling, dose-response, and its applications to safety and risk assessments, this book is a foundational resource that provides practical coverage of PBPK modeling for graduate students, academics, researchers, and more. Provides end-of-chapter exercises to teach hands-on computational tools used in toxicology Supplies computer code and explanations and includes examples of applied models used in regulatory toxicology and research Authored by expert editors and contributors who are among the best PBPK modelers in the world

Physiologically Based Pharmacokinetic Modeling


Physiologically Based Pharmacokinetic Modeling
  • Author : Micaela Reddy
  • Publisher : John Wiley & Sons
  • Release : 2005-06-14
  • ISBN : 9780471478775
  • Language : En, Es, Fr & De
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A definitive, single source of information on PBPK modeling Physiologically-based pharmacokinetic (PBPK) modeling is becomingincreasingly important in human health risk assessments and insupporting pharmacodynamic modeling for toxic responses. Organizedby classes of compounds and modeling purposes so users can quicklyaccess information, this is the first comprehensive reference ofits kind. This book presents an overview of the underlying principles of PBPKmodel development. Then it provides a compendium of PBPK modelinginformation, including historical development, specific modelingchallenges, and current practices for: * Halogenated Alkanes * Halogenated Alkenes * Alkene and Aromatic Compounds * Reactive Vapors in the Nasal Cavity * Alkanes, Oxyhydrocarbons, and Related Compounds * Pesticides and Persistent Organic Pollutants * Dioxin and Related Compounds * Metals and Inorganic Compounds * Drugs * Antineoplastic Agents * Perinatal Transfer * Mixtures * Dermal Exposure Models In addition to pinpointing specific information, readers canexplore diverse modeling techniques and applications. Anauthoritative reference for toxicologists, ecotoxicologists, riskassessors, regulators, pharmacologists, pharmacists, and graduatestudents in pharmacokinetics and toxicology, Physiologically-BasedPharmacokinetic Modeling compiles information from leaders in thefield and discusses future directions for PBPK modeling.

Physiologically Based Pharmacokinetic PBPK Modeling and Simulations


Physiologically Based Pharmacokinetic  PBPK  Modeling and Simulations
  • Author : Sheila Annie Peters
  • Publisher : John Wiley & Sons
  • Release : 2012-02-29
  • ISBN : 9781118140383
  • Language : En, Es, Fr & De
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The only book dedicated to physiologically-based pharmacokineticmodeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has becomeincreasingly widespread within the pharmaceutical industry over thelast decade, but without one dedicated book that provides theinformation researchers need to learn these new techniques, itsapplications are severely limited. Describing the principles,methods, and applications of PBPK modeling as used inpharmaceutics, Physiologically-Based Pharmacokinetic (PBPK)Modeling and Simulations fills this void. Connecting theory with practice, the book explores theincredible potential of PBPK modeling for improving drug discoveryand development. Comprised of two parts, the book first provides adetailed and systematic treatment of the principles behindphysiological modeling of pharmacokinetic processes,inter-individual variability, and drug interactions for smallmolecule drugs and biologics. The second part looks in greaterdetail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for abrief overview of the field as well as those who need more detail,the book includes a range of important learning aids. Featuringend-of-chapter keywords for easy reference—a valuable assetfor general or novice readers without a PBPK background—alongwith an extensive bibliography for those looking for furtherinformation, Physiologically- Based Pharmacokinetic (PBPK) Modelingand Simulations is the essential single-volume text on one of thehottest topics in the pharmaceutical sciences today.

Mechanistic Physiologically Based Pharmacokinetic PBPK Modeling of Renal and Systemic Disposition of Drugs and Metabolites


Mechanistic Physiologically Based Pharmacokinetic  PBPK  Modeling of Renal and Systemic Disposition of Drugs and Metabolites
  • Author : Weize Huang
  • Publisher :
  • Release : 2020
  • ISBN : OCLC:1196247018
  • Language : En, Es, Fr & De
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Physiologically-based pharmacokinetic (PBPK) models integrate system specific anatomy and physiology information with drug specific physicochemical and pharmacokinetic properties to predict drug disposition. Such integration permits items, events, processes, and pathways to communicate and influence each other interactively. By taking advantage of such mechanistic nature of PBPK modeling, drug dispositions under untested scenarios could be predicted by extrapolation from observed data in known conditions. Renal clearance is one of the major pathways governing drug dispositions, which has three main mechanisms: unbound filtration, passive reabsorption, and active secretion. In comparison to intestinal absorption and hepatic metabolism, renal clearance has been relatively underappreciated. Controlled clinical experiments that test renal clearance changes under altered conditions and mechanisms have been primarily focusing on drug-drug interaction on active secretion. However, huge gaps in understanding renal clearance still exist in other areas such as altered urine pH and impaired renal function. Further, passive reabsorption has not been paid significant attention by the pharmaceutical field. Therefore, the overarching goal of this thesis is to leverage mechanistic PBPK modeling technique to understand and predict renal clearance of drugs and metabolites under altered urine pH and impaired renal function, with a special focus on compounds undergoing significant renal passive reabsorption. In Chapter 2, to predict the spatiodynamic process of renal passive reabsorption in human, we developed a dynamic physiologically-based mechanistic kidney model based on human data that can integrate drug permeability, tubular surface area, ionization status, and drug concentration gradient between lumen and system to estimate renal passive reabsorption and predict renal clearance of drugs. Using 46 test compounds with a variety of physicochemical properties, the model successfully predicted the renal clearances of 87% compounds within 2-fold and 98% compounds within 3-fold. Further, by incorporating active secretion, the model also successfully predicted the renal clearances of para-aminohippuric acid (PAH), cimetidine, salicylic acid, and memantine. In Chapter 3, to ensure the simulation output from PBPK models can be meaningfully compared to the arm vein plasma drug concentrations collected in clinical studies, we developed a forearm model that captures the tissue distribution at the peripheral sampling site using human arm physiology data, allowing for a better prediction of plasma drug concentrations that are comparable to observed data. The model was successfully verified using arterial and venous concentrations of nicotine, ketamine, lidocaine, and fentanyl simultaneously. Further, I demonstrated that use of a discrepant sampling site in PBPK modeling than observed clinical studies may lead to biased model evaluation, erroneous model parameterization, and misleading prediction in unstudied clinical scenarios. In Chapter 4, to predict the altered renal excretion and systemic AUC of drug and metabolite when urine pH is changed, the mechanistic kidney model developed and verified from Chapter 2 was integrated with the peripheral arm sampling and full body PBPK model developed from Chapter 3. The model was successfully verified with methamphetamine and amphetamine under varying urine pH statuses, and showed feasibility to predict quantitatively and clinically significant changes in drug and metabolite disposition under comedications and diseases that can alter urine pH. In Chapter 5, to predict renal clearance in patients with impaired renal function such as chronic kidney diseases, physiological changes in tubular flow and urine flow observed in chronic kidney disease patients were incorporated into the mechanistic kidney model developed and verified from Chapter 2. The model accounts for the adaptive renal tubular filtrate flows that decrease disproportionately with glomerular filtration rate, and was successfully verified using three parent-metabolite pairs, six non-permeable drugs, six permeable drugs, and two secreted drugs. In conclusion, in this thesis, I developed and verified a physiologically-based mechanistic kidney model to translate drug properties such as plasma protein binding, transcellular permeability, and active transport into renal clearance of drugs and metabolites. This mechanistic kidney model allows prediction of alterations in renal clearance of drugs and metabolites upon changes in urine pH and renal functions, and can be incorporated into a full-body PBPK model to predict alterations in systemic disposition of drugs and metabolites.