{"product_id":"drug-delivery-approaches-isbn-9781119772736","title":"Drug Delivery Approaches","description":"\u003cp\u003e\u003cb\u003eExplore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003eDrug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics\u003c\/i\u003e delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. \u003c\/p\u003e\u003cp\u003eThe distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK\/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. \u003c\/p\u003e\u003cp\u003eReaders will also benefit from the inclusion of: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA thorough introduction to the utility of mathematical models in drug development and delivery\u003c\/li\u003e \u003cli\u003eAn exploration of the techniques and applications of physiologically based models to drug delivery\u003c\/li\u003e \u003cli\u003eDiscussions of oral delivery and pharmacokinetic models and oral site-directed delivery\u003c\/li\u003e \u003cli\u003eA review of integrated transdermal delivery and pharmacokinetics in development\u003c\/li\u003e \u003cli\u003eAn examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms\u003c\/li\u003e \u003cli\u003eAlternative endpoints to pharmacokinetics for topical delivery\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, \u003ci\u003eDrug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics\u003c\/i\u003e will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.In diesem Werk werden Möglichkeiten der Wirkstoffverabreichung dargestellt, wobei physikalische und pharmakokinetische Modelle zur Erzielung der gewünschten Profile und Ansätze herangezogen werden. Nach einem Überblick über die Wirkstoffaufnahme und die physiologischen Modelle werden in den Kapiteln über die oralen Verabreichungswege (die häufigste Form der Verabreichung) die PBPK und verschiedene mögliche Darreichungsformen beschrieben. Bei der systemischen transdermalen Verabreichung ist es notwendig, die Pharmakokinetik der Formulierung und des Wirkstoffs zu verstehen, um die Formulierung von der ersten Konzeption über die gesamte Entwicklung darauf auszurichten. In weiteren Kapiteln werden die biologischen und praktischen Ansätze bei der pulmonalen und mukosalen Verabreichung besprochen. Für den Fall der Notfallversorgung betrachten die Autoren die Beziehung zwischen parenteralen Infusionsprofilen und PK\/PD. In den letzten Kapiteln werden aktuelle Trends dargestellt, darunter virtuelle Experimente zur Verdeutlichung von Mechanismen sowie moderne Ansätze in der Wirkstoffverabreichung und personalisierten Medizin.\u003cbr\u003e Das Werk Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics eignet sich nicht nur perfekt für Wissenschaftler, Forscher in der Industrie, Doktoranden und Postdoktoranden in den Bereichen der Pharmawissenschaft und Pharmatechnik, sondern verdient auch einen Platz in den Bücherregalen von Experten, die sich mit Formulierungen, Pharmakokinetik und klinischer Pharmakologie beschäftigen. \u003c\/p\u003e\u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction: Utility of Mathematical Models in Drug Development and Delivery \u003c\/b\u003e\u003cb\u003e1\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eToufigh Gordi and Bret Berner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 Use of Mathematical Models in Drug Development 2\u003c\/p\u003e \u003cp\u003e1.3 Noncompartmental Analysis 3\u003c\/p\u003e \u003cp\u003e1.4 Pharmacokinetic (PK) Models 5\u003c\/p\u003e \u003cp\u003e1.5 Physiologically Based Pharmacokinetic (PBPK) Models 7\u003c\/p\u003e \u003cp\u003e1.6 Pharmacokinetic\/Pharmacodynamic (PK\/PD) Models 9\u003c\/p\u003e \u003cp\u003e1.7 Systems Pharmacology Models 12\u003c\/p\u003e \u003cp\u003e1.8 Utility of PK\/PD Analysis and Models in Drug Development 14\u003c\/p\u003e \u003cp\u003e1.8.1 Drug Delivery and PK\/PD 26\u003c\/p\u003e \u003cp\u003e1.8.2 Drug Properties and Mechanism of Release from the Dosage Form 27\u003c\/p\u003e \u003cp\u003e1.8.2.1 Temporal Pattern of Delivery 30\u003c\/p\u003e \u003cp\u003e1.9 Discussion 32\u003c\/p\u003e \u003cp\u003eReferences 34\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Physiologically Based Models: Techniques and Applications to Drug Delivery \u003c\/b\u003e\u003cb\u003e43\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eRichard N. Upton, Ashley M. Hopkins, Ahmad Y. Abuhelwa, Jim H. Hughes and David J.R. Foster\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 43\u003c\/p\u003e \u003cp\u003e2.2 Types of Pharmacokinetic Models 43\u003c\/p\u003e \u003cp\u003e2.3 Commercial vs. Bespoke PBPK Models 45\u003c\/p\u003e \u003cp\u003e2.4 Data Sources 46\u003c\/p\u003e \u003cp\u003e2.5 Applications of PBPK Models 46\u003c\/p\u003e \u003cp\u003e2.6 Techniques of PBPK Modeling 48\u003c\/p\u003e \u003cp\u003e2.6.1 The “Language” of PBPK Models 48\u003c\/p\u003e \u003cp\u003e2.6.2 Oral Absorption Models 49\u003c\/p\u003e \u003cp\u003e2.6.3 Drug Metabolism and Drug–Drug Interactions 56\u003c\/p\u003e \u003cp\u003e2.6.4 Drug Transporters 58\u003c\/p\u003e \u003cp\u003e2.6.5 Renal Elimination 59\u003c\/p\u003e \u003cp\u003e2.6.6 Protein Binding 59\u003c\/p\u003e \u003cp\u003e2.6.7 Accounting for Size 61\u003c\/p\u003e \u003cp\u003e2.6.8 Accounting for Age 63\u003c\/p\u003e \u003cp\u003e2.6.9 Interspecies Scaling 64\u003c\/p\u003e \u003cp\u003e2.6.10 Between-Subject Variability 65\u003c\/p\u003e \u003cp\u003e2.6.11 Sensitivity Analysis 66\u003c\/p\u003e \u003cp\u003e2.6.12 Pharmacodynamics 66\u003c\/p\u003e \u003cp\u003e2.7 Summary 68\u003c\/p\u003e \u003cp\u003eReferences 68\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Oral Delivery and Pharmacokinetic Models \u003c\/b\u003e\u003cb\u003e75\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eWojciech Krzyzanski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 75\u003c\/p\u003e \u003cp\u003e3.2 Compartmental Models 76\u003c\/p\u003e \u003cp\u003e3.2.1 First-Order Absorption 76\u003c\/p\u003e \u003cp\u003e3.2.2 Zero-Order Absorption 78\u003c\/p\u003e \u003cp\u003e3.2.3 Absorption Delay 78\u003c\/p\u003e \u003cp\u003e3.2.4 Parallel Inputs 80\u003c\/p\u003e \u003cp\u003e3.2.5 Discontinuous Absorption 81\u003c\/p\u003e \u003cp\u003e3.2.6 Compartmental Absorption and Transit 81\u003c\/p\u003e \u003cp\u003e3.2.7 Gastrointestinal Transit Time 82\u003c\/p\u003e \u003cp\u003e3.2.8 Other Compartmental Models 82\u003c\/p\u003e \u003cp\u003e3.3 Empirical Models 82\u003c\/p\u003e \u003cp\u003e3.3.1 Gamma Model 83\u003c\/p\u003e \u003cp\u003e3.3.2 Weibull Model 83\u003c\/p\u003e \u003cp\u003e3.3.3 Inverse Gaussian Model 85\u003c\/p\u003e \u003cp\u003e3.4 Physiologically Based Pharmacokinetic Models of Drug Absorption 85\u003c\/p\u003e \u003cp\u003e3.4.1 Traditional and Segregated-Flow Models 86\u003c\/p\u003e \u003cp\u003e3.5 Advanced PBPK Models 88\u003c\/p\u003e \u003cp\u003e3.5.1 Advanced Compartmental Absorption and Transit Model 88\u003c\/p\u003e \u003cp\u003e3.5.2 Advanced Dissolution Absorption and Metabolism Model 89\u003c\/p\u003e \u003cp\u003e3.6 Intestinal First-pass Drug Metabolism 90\u003c\/p\u003e \u003cp\u003e3.6.1 Well-stirred Gut Model 90\u003c\/p\u003e \u003cp\u003e3.6.2 \u003ci\u003eQ\u003c\/i\u003e\u003csub\u003eGut\u003c\/sub\u003e Model 91\u003c\/p\u003e \u003cp\u003e3.7 Spatiotemporal Models of Drug Absorption 91\u003c\/p\u003e \u003cp\u003e3.7.1 Dispersion Model 92\u003c\/p\u003e \u003cp\u003e3.7.2 Translocation Model 92\u003c\/p\u003e \u003cp\u003e3.8 Conclusions 93\u003c\/p\u003e \u003cp\u003eReferences 94\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Oral Site-Directed Drug Delivery and Influence on PK \u003c\/b\u003e\u003cb\u003e99\u003cbr\u003e\u003c\/b\u003e\u003ci\u003ePeter Scholes, Vanessa Zann, Wu Lin, Chris Roe and Bret Berner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 99\u003c\/p\u003e \u003cp\u003e4.2 GI Anatomy and Physiology 99\u003c\/p\u003e \u003cp\u003e4.2.1 Anatomy 100\u003c\/p\u003e \u003cp\u003e4.2.2 Regional Variations in Physiology Affecting Drug Delivery 101\u003c\/p\u003e \u003cp\u003e4.2.2.1 Fluid Volume and pH 101\u003c\/p\u003e \u003cp\u003e4.2.2.2 Enzymes, GutWall Metabolism, Tissue Permeability, and Transporters 102\u003c\/p\u003e \u003cp\u003e4.2.2.3 Gender and Age Effects 111\u003c\/p\u003e \u003cp\u003e4.2.2.4 GI Transit 112\u003c\/p\u003e \u003cp\u003e4.2.2.5 Effect of Food 114\u003c\/p\u003e \u003cp\u003e4.2.2.6 Enterohepatic Circulation 115\u003c\/p\u003e \u003cp\u003e4.3 Biopharmaceutics Classification System (BCS) 116\u003c\/p\u003e \u003cp\u003e4.3.1 Background and Regulatory Perspectives 116\u003c\/p\u003e \u003cp\u003e4.3.2 Determining a Solubility Class 119\u003c\/p\u003e \u003cp\u003e4.3.3 Determining a Permeability Class 123\u003c\/p\u003e \u003cp\u003e4.3.4 Determining Dissolution of the Drug Product 125\u003c\/p\u003e \u003cp\u003e4.3.5 GI Stability 126\u003c\/p\u003e \u003cp\u003e4.3.6 Applications and Limitations of BCS Classification 126\u003c\/p\u003e \u003cp\u003e4.3.7 “Developability Classification System” 129\u003c\/p\u003e \u003cp\u003e4.4 Applications and Limitations of Characterization and Predictive Tools 131\u003c\/p\u003e \u003cp\u003e4.4.1 In Silico Tools: Predictive Models, Molecular Descriptors, and ADMET 131\u003c\/p\u003e \u003cp\u003e4.4.2 In Vitro Tools 133\u003c\/p\u003e \u003cp\u003e4.4.2.1 PAMPA 133\u003c\/p\u003e \u003cp\u003e4.4.2.2 Cell Lines 135\u003c\/p\u003e \u003cp\u003e4.4.3 Ex Vivo Tools 137\u003c\/p\u003e \u003cp\u003e4.4.3.1 Ussing Chambers 137\u003c\/p\u003e \u003cp\u003e4.4.3.2 Everted Intestinal Sac\/Ring 140\u003c\/p\u003e \u003cp\u003e4.4.4 In Situ Tools 142\u003c\/p\u003e \u003cp\u003e4.4.4.1 Closed Loop Intestinal Perfusion 143\u003c\/p\u003e \u003cp\u003e4.4.4.2 Single-Pass Intestinal Perfusion 143\u003c\/p\u003e \u003cp\u003e4.4.4.3 Intestinal Perfusion with Venous Sampling 143\u003c\/p\u003e \u003cp\u003e4.4.4.4 Vascularly Perfused Intestinal Models 144\u003c\/p\u003e \u003cp\u003e4.4.4.5 Other Animal Models 144\u003c\/p\u003e \u003cp\u003e4.4.5 In Vivo Tools 145\u003c\/p\u003e \u003cp\u003e4.4.6 In Silico Tools for Prediction of PK and PK\/PD 146\u003c\/p\u003e \u003cp\u003e4.4.7 Preclinical PK Models 150\u003c\/p\u003e \u003cp\u003e4.5 Tools to Probe Regional Bioavailability in Humans: Case Studies 151\u003c\/p\u003e \u003cp\u003e4.5.1 Site-Specific Delivery Devices 151\u003c\/p\u003e \u003cp\u003e4.5.2 Gamma Scintigraphic Imaging 157\u003c\/p\u003e \u003cp\u003e4.5.3 Magnetic Resonance Imaging (MRI) 159\u003c\/p\u003e \u003cp\u003e4.6 Rational Formulation Design and Effective Clinical Evaluation: Case Studies Describing How to Achieve Desired Release Modality and Target PK 160\u003c\/p\u003e \u003cp\u003e4.6.1 Formulation Strategies to Address BCS Classification Challenges 160\u003c\/p\u003e \u003cp\u003e4.6.1.1 Solubilization 160\u003c\/p\u003e \u003cp\u003e4.6.1.2 Permeability Enhancement 168\u003c\/p\u003e \u003cp\u003e4.6.1.3 Concluding Remarks on Strategies for BCS Challenges 170\u003c\/p\u003e \u003cp\u003e4.6.2 Formulation Strategies for Chronotherapeutic and Regional GI Delivery for Local or Systemic Delivery 170\u003c\/p\u003e \u003cp\u003e4.6.2.1 Gastric Retention 170\u003c\/p\u003e \u003cp\u003e4.6.2.2 Enteric-Coated Dosage Forms and Delayed Release to the Small Intestine 182\u003c\/p\u003e \u003cp\u003e4.6.2.3 Delivery to the Jejunum and Ileum 185\u003c\/p\u003e \u003cp\u003e4.6.2.4 Colonic Delivery 186\u003c\/p\u003e \u003cp\u003e4.7 Conclusions 191\u003c\/p\u003e \u003cp\u003eReferences 191\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 The Vasoconstrictor Assay (VCA): Then and Now \u003c\/b\u003e\u003cb\u003e221\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eIsadore Kanfer and Howard Maibach\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 221\u003c\/p\u003e \u003cp\u003e5.1.1 Applications and Procedures 222\u003c\/p\u003e \u003cp\u003e5.1.2 Visual Assessment 224\u003c\/p\u003e \u003cp\u003e5.1.3 Chromameter Assessment 225\u003c\/p\u003e \u003cp\u003e5.1.3.1 Comparison Between Visual and Chromameter Assessment 226\u003c\/p\u003e \u003cp\u003e5.2 Issues and Controversies 228\u003c\/p\u003e \u003cp\u003e5.2.1 Fitting of PD Response Data 228\u003c\/p\u003e \u003cp\u003e5.2.2 Circadian Activity 229\u003c\/p\u003e \u003cp\u003e5.2.3 BE Studies Performed Under Occlusion 230\u003c\/p\u003e \u003cp\u003e5.2.4 Erythema Response at Application Sites 230\u003c\/p\u003e \u003cp\u003e5.2.5 Use of VCA for Market Approval in the European Union 231\u003c\/p\u003e \u003cp\u003e5.2.6 Potency Ranking of Topical Corticosteroid Products 232\u003c\/p\u003e \u003cp\u003e5.2.7 Sensitive Region of the Dose–Response Curve 234\u003c\/p\u003e \u003cp\u003e5.2.8 Correlation of ED\u003csub\u003e50\u003c\/sub\u003e with Potency Classification of a Product? 235\u003c\/p\u003e \u003cp\u003e5.3 Conclusions 236\u003c\/p\u003e \u003cp\u003eReferences 236\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Topical Delivery: Toward an IVIVC \u003c\/b\u003e\u003cb\u003e241\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eSam G. Raney and Thomas J. Franz\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 241\u003c\/p\u003e \u003cp\u003e6.2 In Vitro–In Vivo Correlation: Validating the Model of Topical Delivery 241\u003c\/p\u003e \u003cp\u003e6.3 In Vitro–In Vivo Correlation: Transdermal Delivery 244\u003c\/p\u003e \u003cp\u003e6.4 In Vitro–In Vivo Correlation: Bioavailability and Bioequivalence 245\u003c\/p\u003e \u003cp\u003e6.5 Summary 250\u003c\/p\u003e \u003cp\u003eDisclaimer 250\u003c\/p\u003e \u003cp\u003eReferences 250\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Integrated Transdermal Drug Delivery and Pharmacokinetics in Development \u003c\/b\u003e\u003cb\u003e253\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eBret Berner and Gregory M. Kochak\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 253\u003c\/p\u003e \u003cp\u003e7.2 Fundamentals of Transdermal Delivery 254\u003c\/p\u003e \u003cp\u003e7.2.1 Architecture of Skin 254\u003c\/p\u003e \u003cp\u003e7.2.2 Skin Permeation and Transdermal Delivery 255\u003c\/p\u003e \u003cp\u003e7.2.3 Basic Pharmacokinetics of Transdermal Delivery 262\u003c\/p\u003e \u003cp\u003e7.3 In Vivo Assessment of Drug Input and Pharmacokinetic Disposition 266\u003c\/p\u003e \u003cp\u003e7.3.1 Deconvolution 266\u003c\/p\u003e \u003cp\u003e7.3.2 Convolution 267\u003c\/p\u003e \u003cp\u003e7.3.3 Instability in Deconvolution 269\u003c\/p\u003e \u003cp\u003e7.3.4 Generalized Input and Convolution 272\u003c\/p\u003e \u003cp\u003e7.4 In Vitro Testing: Drug Release from Transdermal Systems 273\u003c\/p\u003e \u003cp\u003e7.5 In Vitro\/In Vivo Correlation 275\u003c\/p\u003e \u003cp\u003e7.6 Clinical Safety and Efficacy Studies for Dermal Drug Development 280\u003c\/p\u003e \u003cp\u003e7.6.1 Bioavailability and Bioequivalence 281\u003c\/p\u003e \u003cp\u003e7.6.2 Skin Irritation and Sensitization Study 282\u003c\/p\u003e \u003cp\u003e7.7 Dosage Form Proportionality Scaling and Dose Proportionality 283\u003c\/p\u003e \u003cp\u003e7.7.1 Residual Content of the Dosage Form 283\u003c\/p\u003e \u003cp\u003e7.7.2 Comparative Toxicity and Efficacy 283\u003c\/p\u003e \u003cp\u003e7.8 Supporting In Vitro Studies 283\u003c\/p\u003e \u003cp\u003e7.9 Safety Studies Related to Environmental Conditions Such as Heat and Storage Conditions 284\u003c\/p\u003e \u003cp\u003e7.10 Active Transdermal Systems That Enhance Barrier Penetration 284\u003c\/p\u003e \u003cp\u003e7.10.1 Microneedles 284\u003c\/p\u003e \u003cp\u003e7.10.2 Thermal or Radio Frequency Ablation 287\u003c\/p\u003e \u003cp\u003e7.10.3 Sonophoresis 288\u003c\/p\u003e \u003cp\u003e7.10.4 Electrical 289\u003c\/p\u003e \u003cp\u003e7.10.4.1 Electroporation 289\u003c\/p\u003e \u003cp\u003e7.10.4.2 Iontophoresis 290\u003c\/p\u003e \u003cp\u003e7.11 Conclusion 293\u003c\/p\u003e \u003cp\u003eReferences 293\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Formulation and Pharmacokinetic Challenges Associated with Targeted Pulmonary Drug Delivery \u003c\/b\u003e\u003cb\u003e305\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eTomoyuki Okuda and Hak-Kim Chan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Progress on Formulations and Devices for Inhaled Drugs 305\u003c\/p\u003e \u003cp\u003e8.2 Challenges for Inhaled Formulations 308\u003c\/p\u003e \u003cp\u003e8.2.1 High-Dose Drugs and Amorphous Powders 308\u003c\/p\u003e \u003cp\u003e8.2.2 Generic DPI Formulations 309\u003c\/p\u003e \u003cp\u003e8.2.3 Biologics and Macromolecules 310\u003c\/p\u003e \u003cp\u003e8.2.4 Controlled Release Formulations 310\u003c\/p\u003e \u003cp\u003e8.3 Factors Determining the Fate of Inhaled Drugs in the Body 311\u003c\/p\u003e \u003cp\u003e8.3.1 Anatomical and Histological Characteristics of the Respiratory System 311\u003c\/p\u003e \u003cp\u003e8.3.2 Physicochemical Characteristics of Inhaled Drugs 312\u003c\/p\u003e \u003cp\u003e8.4 Pharmacokinetic\/Pharmacodynamic Correlation of Inhaled Drugs 314\u003c\/p\u003e \u003cp\u003e8.4.1 Desirable Pharmacokinetic Parameters of Inhaled Drugs for Local Action and Systemic Delivery 314\u003c\/p\u003e \u003cp\u003e8.4.2 Pharmacokinetic\/Pharmacodynamic Correlation of Clinically Approved Inhaled Drugs 315\u003c\/p\u003e \u003cp\u003e8.4.2.1 Corticosteroids and Bronchodilators 315\u003c\/p\u003e \u003cp\u003e8.4.2.2 Antimicrobials 316\u003c\/p\u003e \u003cp\u003e8.4.2.3 Prostacyclin Analogs 317\u003c\/p\u003e \u003cp\u003e8.4.2.4 Loxapine 318\u003c\/p\u003e \u003cp\u003e8.4.2.5 Insulin 318\u003c\/p\u003e \u003cp\u003e8.5 Application of Drug Delivery System for Improving Pharmacokinetic\/Pharmacodynamic Parameters of Inhaled Drugs 320\u003c\/p\u003e \u003cp\u003e8.5.1 Chemical Modification 320\u003c\/p\u003e \u003cp\u003e8.5.2 Functional Micro\/Nanoparticle Formulations 321\u003c\/p\u003e \u003cp\u003e8.5.3 Active Targeting 322\u003c\/p\u003e \u003cp\u003e8.6 Conclusion 323\u003c\/p\u003e \u003cp\u003eReferences 324\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Oral Transmucosal Drug Delivery \u003c\/b\u003e\u003cb\u003e333\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMohammed Sattar and Majella E. Lane\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 333\u003c\/p\u003e \u003cp\u003e9.2 Structure and Physiology of the Oral Mucosa 334\u003c\/p\u003e \u003cp\u003e9.2.1 Buccal Mucosa 334\u003c\/p\u003e \u003cp\u003e9.2.2 Sublingual Mucosa 335\u003c\/p\u003e \u003cp\u003e9.2.3 Gingiva and Palate 336\u003c\/p\u003e \u003cp\u003e9.2.4 Saliva 336\u003c\/p\u003e \u003cp\u003e9.2.5 Mucus 336\u003c\/p\u003e \u003cp\u003e9.2.6 Permeation Routes 336\u003c\/p\u003e \u003cp\u003e9.3 Drug Properties Which Influence OTMD 337\u003c\/p\u003e \u003cp\u003e9.3.1 Molecular Weight 337\u003c\/p\u003e \u003cp\u003e9.3.2 Lipid Solubility 338\u003c\/p\u003e \u003cp\u003e9.3.3 Degree of Ionization 339\u003c\/p\u003e \u003cp\u003e9.3.4 Potency 340\u003c\/p\u003e \u003cp\u003e9.4 Buccal and Sublingual Formulations 340\u003c\/p\u003e \u003cp\u003e9.4.1 Currently Used Technologies 340\u003c\/p\u003e \u003cp\u003e9.4.2 Investigation of Iontophoresis for Oral Transmucosal Drug Delivery 342\u003c\/p\u003e \u003cp\u003e9.5 Models to Study OTDD 342\u003c\/p\u003e \u003cp\u003e9.5.1 Studies in Man and Human Tissue Models 342\u003c\/p\u003e \u003cp\u003e9.5.2 Porcine Tissue Models 343\u003c\/p\u003e \u003cp\u003e9.5.3 Dog, Monkey, and Rabbit Models 344\u003c\/p\u003e \u003cp\u003e9.5.4 Chicken, Hamster, and Rat Models 345\u003c\/p\u003e \u003cp\u003e9.5.5 Cell Culture Models 345\u003c\/p\u003e \u003cp\u003e9.6 Feasibility of Systemic Delivery Based on In Vitro Permeation Studies 346\u003c\/p\u003e \u003cp\u003e9.7 Conclusion 347\u003c\/p\u003e \u003cp\u003eReferences 347\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 PK\/PD and the Drug Delivery Regimen for Infusion in the Critical Care Setting \u003c\/b\u003e\u003cb\u003e355\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eFekade B. Sime and Jason A. Roberts\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 355\u003c\/p\u003e \u003cp\u003e10.2 PK\/PD Properties and the Mode of Infusional Drug Delivery for Antibiotics 356\u003c\/p\u003e \u003cp\u003e10.3 Changes in PK\u003ci\u003e\/\u003c\/i\u003ePD and Infusional Drug Delivery Regimens in Critically Ill Patients 357\u003c\/p\u003e \u003cp\u003e10.4 Short Intermittent Infusions 359\u003c\/p\u003e \u003cp\u003e10.5 Extended Infusions 360\u003c\/p\u003e \u003cp\u003e10.6 Continuous Infusion 361\u003c\/p\u003e \u003cp\u003e10.6.1 Continuous Infusion of β-Lactam Antibiotics 361\u003c\/p\u003e \u003cp\u003e10.6.2 Continuous Infusion of Vancomycin 366\u003c\/p\u003e \u003cp\u003e10.7 Conclusions 367\u003c\/p\u003e \u003cp\u003eReferences 367\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Virtual Experiment Methods for Integrating Pharmacokinetic, Pharmacodynamic, and Drug Delivery Mechanisms: Demonstrating Feasibility for Acetaminophen Hepatotoxicity \u003c\/b\u003e\u003cb\u003e375\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eAndrew K. Smith, Ryan C. Kennedy, Brenden K. Petersen, Glen E.P. Ropella and Carver Anthony Hunt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 375\u003c\/p\u003e \u003cp\u003e11.1.1 Focus on Acetaminophen-Induced Liver Injury 376\u003c\/p\u003e \u003cp\u003e11.2 Results 377\u003c\/p\u003e \u003cp\u003e11.2.1 Engineering Parsimonious Fit for Purpose Virtual Mice 377\u003c\/p\u003e \u003cp\u003e11.2.2 Concrete Lobule Location-Dependent Mechanisms 380\u003c\/p\u003e \u003cp\u003e11.2.3 Falsifying Virtual Mechanisms 381\u003c\/p\u003e \u003cp\u003e11.2.4 A Plausible Causal Cascade 383\u003c\/p\u003e \u003cp\u003e11.2.5 Drug Delivery and a Therapeutic Intervention 385\u003c\/p\u003e \u003cp\u003e11.3 Methods 386\u003c\/p\u003e \u003cp\u003e11.3.1 Broad Requirements 386\u003c\/p\u003e \u003cp\u003e11.3.2 Prediction 388\u003c\/p\u003e \u003cp\u003e11.3.3 Iterative Refinement Protocol 388\u003c\/p\u003e \u003cp\u003e11.3.4 Data Types, Reuse, and Sharing 390\u003c\/p\u003e \u003cp\u003e11.3.5 Quality Assurance and Control 390\u003c\/p\u003e \u003cp\u003e11.3.6 Building Mouse Analog Credibility 391\u003c\/p\u003e \u003cp\u003e11.3.6.1 Validation 391\u003c\/p\u003e \u003cp\u003e11.3.6.2 Verification 392\u003c\/p\u003e \u003cp\u003e11.3.7 Liver and Lobular Form and Function 392\u003c\/p\u003e \u003cp\u003e11.3.8 APAP Metabolism 393\u003c\/p\u003e \u003cp\u003e11.3.9 PP-to-CV Gradients 394\u003c\/p\u003e \u003cp\u003e11.3.10 GSH Depletion 394\u003c\/p\u003e \u003cp\u003e11.3.11 Damage Products 395\u003c\/p\u003e \u003cp\u003e11.3.12 Triggering Hepatocyte Death 395\u003c\/p\u003e \u003cp\u003e11.3.13 Repair Events 395\u003c\/p\u003e \u003cp\u003e11.3.14 Sensitivity Analyses and Uncertainty Quantification 396\u003c\/p\u003e \u003cp\u003e11.3.15 Mouse Body 397\u003c\/p\u003e \u003cp\u003e11.3.16 Death Delay 399\u003c\/p\u003e \u003cp\u003e11.4 Discussion 399\u003c\/p\u003e \u003cp\u003eReferences 402\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Personalized Medicine: Drug Delivery and Pharmacokinetics \u003c\/b\u003e\u003cb\u003e407\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMelanie A. Felmlee and Xiaoling Li\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Personalized Medicine 407\u003c\/p\u003e \u003cp\u003e12.2 Drug Delivery in Personalized Medicine 409\u003c\/p\u003e \u003cp\u003e12.2.1 Delivery Approaches to Alter Dose 410\u003c\/p\u003e \u003cp\u003e12.2.2 Delivery Approaches That Alter Pharmacokinetic Parameters 412\u003c\/p\u003e \u003cp\u003e12.2.3 Targeted Delivery Approaches 413\u003c\/p\u003e \u003cp\u003e12.3 Pharmacokinetic Analysis for Personalized Drug Delivery 414\u003c\/p\u003e \u003cp\u003e12.3.1 Pharmacokinetic Analysis for Non-targeted Delivery Approaches 414\u003c\/p\u003e \u003cp\u003e12.3.2 Pharmacokinetic Analysis for Targeted Delivery Approaches 416\u003c\/p\u003e \u003cp\u003e12.4 Challenges and Opportunities in Personalized Drug Delivery 417\u003c\/p\u003e \u003cp\u003e12.5 Conclusions 418\u003c\/p\u003e \u003cp\u003eReferences 419\u003c\/p\u003e \u003cp\u003eIndex 423\u003c\/p\u003e \u003cp\u003e\u003cb\u003eBret Berner, PhD,\u003c\/b\u003e is a pharmaceutical consultant in drug delivery, formulation, and pharmacokinetics. He was formerly Director of Basic Pharmaceutics Research at Ciba-Geigy, Vice President of Development  at Cygnus Therapeutics, and Chief Scientific Officer at Depomed. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eToufigh Gordi, PhD,\u003c\/b\u003e is a Senior Director of clinical pharmacology at Rigel Pharmaceuticals, with extensive experience in using pharmacokinetic and pharmacodynamic modeling to advance candidate drug molecules from preclinical through late phase confirmatory clinical studies. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eHeather A. E. Benson, PhD, \u003c\/b\u003eis Associate Professor in Curtin Medical School at Curtin University, Australia where she leads the Skin Delivery Research Group \u003c\/p\u003e\u003cp\u003e\u003cb\u003eMichael S. Roberts, PhD,\u003c\/b\u003e is Professor of Therapeutics and Pharmaceutical Science at the University of South Australia and Professor of Clinical Pharmacology and Therapeutics at the University  of Queensland.  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eExplore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003eDrug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics\u003c\/i\u003e delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. \u003c\/p\u003e\u003cp\u003eThe distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK\/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. \u003c\/p\u003e\u003cp\u003eReaders will also benefit from the inclusion of: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA thorough introduction to the utility of mathematical models in drug development and delivery\u003c\/li\u003e \u003cli\u003eAn exploration of the techniques and applications of physiologically based models to drug delivery\u003c\/li\u003e \u003cli\u003eDiscussions of oral delivery and pharmacokinetic models and oral site-directed delivery\u003c\/li\u003e \u003cli\u003eA review of integrated transdermal delivery and pharmacokinetics in development\u003c\/li\u003e \u003cli\u003eAn examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms\u003c\/li\u003e \u003cli\u003eAlternative endpoints to pharmacokinetics for topical delivery\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, \u003ci\u003eDrug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics\u003c\/i\u003e will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989087142117,"sku":"NP9781119772736","price":242.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119772736.jpg?v=1761782742","url":"https:\/\/k12savings.com\/es\/products\/drug-delivery-approaches-isbn-9781119772736","provider":"K12savings","version":"1.0","type":"link"}