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Umfang: 1 online resource

ISBN: 9781118140291 , 111814029X , 9781119497813 , 1119497817

Inhalt: Annotation

Anmerkung: Machine generated contents note: PRINCIPLES AND METHODS -- , Modeling In The Pharmaceutical Industry -- , Introduction -- , Modeling Approaches -- , Steps Needed to Maximize Effective Integration of Models into R&D Workflow -- , Scope of the Book -- , Keywords -- , References -- , Physiologically-Based Modeling -- , Introduction -- , Examples of Physiological Modeling -- , Need for Physiological Models in the Pharmaceutical Industry -- , Organs as Compartments -- , Bottom-Up vs. , Top-Down Modeling in Pharmacokinetics -- , References -- , Review Of Pharmacokinetic Principles -- , Introduction -- , Routes of Administration -- , Drug Disposition -- , Absorption -- , Plasma Protein Binding, Blood-Plasma Ratio -- , Distribution, Elimination, Half-Life, and Clearance -- , Role of Transporters in ADME -- , Linear and Nonlinear Pharmacokinetics -- , Steady-State Pharmacokinetics -- , Dose Estimations -- , Successful PK Optimization in Drug Discovery -- , Keywords -- , References -- , Physiological Model For Absorption -- , Introduction -- , Drug Absorption and Gut Bioavailability -- , Solubility and Dissolution Rate -- , Permeability: Transcelluar, Paracellular, and Carrier-Mediated Pathways -- , Barriers to Membrane Transport -- Luminal Degradation, Efflux, and Gut Metabolism -- , Factors Affecting Drug Absorption and Gut Bioavailability -- , Physiological Factors Affecting Oral Drug Absorption and Species Differences in Physiology -- , Compound-Dependent Factors -- , Formulation-Dependent Factors -- , In Silico Predictions of Passive Permeability and Solubility -- , In Silico Models for Permeability -- , In Silico Models for Solubility -- , Measurement of Permeability, Solubility, Luminal Stability, Efflux, and Intestinal Metabolism -- , In Vitro, in Situ and in Vivo Assays for Permeability -- , Measurement of Thermodynamic or Equilibrium Solubility -- , Luminal Stability -- , Efflux -- , In Vitro Models for Estimating Extent of Gut Metabolism -- , Absorption Modeling -- , Keywords -- , References -- , Physiological Model For Distribution -- , Introduction -- , Factors Affecting Tissue Distribution of Xenobiotics -- , Physiological Factors and Species Differences in Physiology -- , Compound-Dependent Factors -- , In Silico Models of Tissue Partition Coefficients -- , Measurement of Parameters Representing Rate and Extent of Tissue Distribution -- , Assessment of Rate and Extent of Brain Penetration -- , Physiological Model for Drug Distribution -- , Drug Concentrations at Site of Action -- , Keywords -- , References -- , Physiological Models For Drug Metabolism And Excretion -- , Introduction -- , Factors Affecting Drug Metabolism and Excretion of Xenobiotics -- , Models for Hepatobiliary Elimination and Renal Excretion -- , In Silico Models -- , In Vitro Models for Hepatic Metabolism -- , In Vitro Models for Transporters -- , Physiological Models -- , Hepatobiliary Elimination of Parent Drug and Metabolites -- , Renal Excretion -- , References -- , Generic Whole-Body Physiologically-Based Pharmacokinetic Modeling -- , Introduction -- , Structure of a Generic Whole Body PBPK Model -- , Model Assumptions -- , Commercial PBPK Software -- , References -- , Variability, Uncertainty, And Sensitivity Analysis -- , Introduction -- , Need for Uncertainty Analysis -- , Sources of Physiological, Anatomical, Enzymatic, and Transporter Variability -- , Modeling Uncertainty and Population Variability with Monte Carlo Simulations -- , Sensitivity Analysis -- , Conclusions -- , Keywords -- , References -- , Evaluation Of Drug-Drug Interaction Risk With Pbpk Models -- , Introduction -- , Factors Affecting Drug -- Drug Interactions -- , In Vitro Methods to Evaluate Drug -- Drug Interactions -- , Candidate Drug as a Potential Inhibitor -- , Candidate Drug as a Potential Victim of Inhibition -- , Static Models to Evaluate Drug -- Drug Interactions -- , PBPK Models to Evaluate Drug -- Drug Interactions -- , Intrinsic Clearance of Victim (V) in the Absence of Inhibitor or Inducer -- , Intrinsic Clearance of Victim (V) in the Presence of Inhibitor -- , Time-Dependent Changes in the Abundance of an Enzyme Isoform Inhibited by an MBI -- , Intrinsic Clearance of Victim (V) in the Presence of Inducer -- , Comparison of PBPK Models and Static Models for the Evaluation of Drug -- Drug Interactions -- , Keywords -- , References -- , Physiologically-Based Pharmacokinetics Of Biotherapeutics -- , Introduction -- , Therapeutic Proteins -- , Peptides and Proteins -- , Monoclonal Antibodies -- , Pharmacokinetics of Therapeutic Proteins -- , Peptides and Proteins -- , Monoclonal Antibodies -- , PBPK/PD Modeling for Therapeutic Proteins -- , Need for PBPK Modeling for Therapeutic Proteins -- , PBPK Modeling for Therapeutic Proteins -- , Pharmacokinetic Scaling -- , Applications of PBPK Models of Therapeutic Proteins -- , PBPK Integration with Pharmacodynamics -- , Antisense Oligonucletides and RNA Interferance -- , Antisense Oligonucletides (ASOs) -- , Ribonucleic Acid Interference (RNAi) -- , Pharmacokinetics of ASOs50 and Double-Stranded RNAs -- , Design and Modifications of ASOs to Improve Target Affinity and PD: the First, Second, and Third Generation ASOs -- , Integration of PK/PBPK and PD Modeling -- , Keywords -- , References -- , APPLICATIONS IN THE PHARMACEUTICAL INDUSTRY -- , Data Integration And Sensitivity Analysis -- , Introduction -- , Examples of Data Integration with PBPK Modeling -- , Examples of Sensitivity Analysis with PBPK Modeling -- , References -- , Hypothesis Generation And Pharmacokinetic Predictions -- , Introduction -- , PBPK Simulations of Pharmacokinetic Profiles for Hypothesis Generation and Testing -- , Methodology -- , In Vivo Solubility -- , Delayed Gastric Emptying -- , Regional Variation in Intestinal Loss: Gut Wall Metabolism, Intestinal Efflux, and Luminal Degradation -- , Enterohepatic Recirculation -- , Inhibition of Drug-Metabolizing Enzymes -- , Inhibition of Hepatic Uptake -- , Inhibition of Hepatobiliary Efflux -- , Pharmacokinetic Predictions -- , Human Predictions from Preclinical Data -- , Pharmacokinetic Predictions in Clinical Development -- , References -- , Integration Of Pbpk And Pharmacodynamics -- , Introduction -- , Pharmacodynamic Principles -- , Pharmacological Targets and Drug Action -- , Functional Adaptation Processes: Tolerance, Sensitization, and Rebound (Fig 13.2) -- , Pharmacodynamic Modeling -- , Concentration -- Effect, Dose -- Response Curves, and Sigmoid Emax Models -- , Mechanism-Based PD Modeling -- , Simple Direct Effects -- , Models Accommodating Delayed Pharmacological Response -- , Models Accommodating Nonlinearity in Pharmacological Response with Respect to Time -- , Pharmacokinetic Modeling: Compartmental PK and PBPK -- , Integration of PK or PBPK with PD Modeling -- , Reasons for Poor PK/PD Correlation -- , Applications of PK or PBPK/PD Modeling in Drug Discovery and Development -- , Need for a Mechanistic PBPK/PD Integration -- , Applications of PK or PBPK/PD in Drug Discovery -- , Applications of PK or PBPK/PD in Drug Development -- , Regulatory Perspective -- , Conclusions -- , Keywords -- , References -- , Physiologically-Based Pharmacokinetic Modeling Of Populations -- , Introduction -- , Population Modeling with PBPK -- , Healthy to Target Patient Population: Impact of Disease on Pharmacokinetics -- , Modeling Subpopulations: Impact of Age, Gender, Co-morbidities, and Genetics on Pharmacokinetics -- , Personalized Medicine with PBPK/PD -- , Keyword -- , References -- , PBPK Models Along The Drug Discovery And Development Value Chain , Summary of Applications of PBPK Models along Value Chain -- , Obstacles and Future Directions for PBPK Modeling -- , Keyword -- , References.

Weitere Ausg.: Print version: Peters, Sheila Annie. Physiologically-based pharmacokinetic (PBPK) modeling and simulations Hoboken, N.J. : Wiley, c2012 ISBN 9780470484067

Sprache: Englisch

Schlagwort(e): Electronic books. ; Electronic books.

URL: https://onlinelibrary.wiley.com/doi/book/10.1002/9781119497813

URL: https://onlinelibrary.wiley.com/doi/book/10.1002/9781119497813

URL: https://onlinelibrary.wiley.com/doi/book/10.1002/9781119497813