Intro -- Table of Contents -- Title Page -- Copyright -- Preface -- 1 Introduction: Utility of Mathematical Models in Drug Development and Delivery -- 1.1 Introduction -- 1.2 Use of Mathematical Models in Drug Development -- 1.3 Noncompartmental Analysis -- 1.4 Pharmacokinetic (PK) Models -- 1.5 Physiologically Based Pharmacokinetic (PBPK) Models -- 1.6 Pharmacokinetic/Pharmacodynamic (PK/PD) Models -- 1.7 Systems Pharmacology Models -- 1.8 Utility of PK/PD Analysis and Models in Drug Development -- 1.9 Discussion -- References -- 2 Physiologically Based Models: Techniques and Applications to Drug Delivery -- 2.1 Introduction -- 2.2 Types of Pharmacokinetic Models -- 2.3 Commercial vs. Bespoke PBPK Models -- 2.4 Data Sources -- 2.5 Applications of PBPK Models -- 2.6 Techniques of PBPK Modeling -- 2.7 Summary -- References -- 3 Oral Delivery and Pharmacokinetic Models -- 3.1 Introduction -- 3.2 Compartmental Models -- 3.3 Empirical Models -- 3.4 Physiologically Based Pharmacokinetic Models of Drug Absorption -- 3.5 Advanced PBPK Models -- 3.6 Intestinal First-pass Drug Metabolism -- 3.7 Spatiotemporal Models of Drug Absorption -- 3.8 Conclusions -- References -- 4 Oral Site-Directed Drug Delivery and Influence on PK -- 4.1 Introduction -- 4.2 GI Anatomy and Physiology -- 4.3 Biopharmaceutics Classification System (BCS) -- 4.4 Applications and Limitations of Characterization and Predictive Tools -- 4.5 Tools to Probe Regional Bioavailability in Humans: Case Studies -- 4.6 Rational Formulation Design and Effective Clinical Evaluation: Case Studies Describing How to Achieve Desired Release Modality and Target PK -- 4.7 Conclusions -- References -- 5 The Vasoconstrictor Assay (VCA): Then and Now -- 5.1 Introduction -- 5.2 Issues and Controversies -- 5.3 Conclusions -- References -- 6 Topical Delivery: Toward an IVIVC -- 6.1 Introduction.

6.2 In Vitro-In Vivo Correlation: Validating the Model of Topical Delivery -- 6.3 In Vitro-In Vivo Correlation: Transdermal Delivery -- 6.4 In Vitro-In Vivo Correlation: Bioavailability and Bioequivalence -- 6.5 Summary -- Disclaimer -- References -- 7 Integrated Transdermal Drug Delivery and Pharmacokinetics in Development -- 7.1 Introduction -- 7.2 Fundamentals of Transdermal Delivery -- 7.3 In Vivo Assessment of Drug Input and Pharmacokinetic Disposition -- 7.4 In Vitro Testing: Drug Release from Transdermal Systems -- 7.5 In Vitro/In Vivo Correlation -- 7.6 Clinical Safety and Efficacy Studies for Dermal Drug Development -- 7.7 Dosage Form Proportionality Scaling and Dose Proportionality -- 7.8 Supporting In Vitro Studies -- 7.9 Safety Studies Related to Environmental Conditions Such as Heat and Storage Conditions -- 7.10 Active Transdermal Systems That Enhance Barrier Penetration -- 7.11 Conclusion -- References -- 8 Formulation and Pharmacokinetic Challenges Associated with Targeted Pulmonary Drug Delivery -- 8.1 Progress on Formulations and Devices for Inhaled Drugs -- 8.2 Challenges for Inhaled Formulations -- 8.3 Factors Determining the Fate of Inhaled Drugs in the Body -- 8.4 Pharmacokinetic/Pharmacodynamic Correlation of Inhaled Drugs -- 8.5 Application of Drug Delivery System for Improving Pharmacokinetic/Pharmacodynamic Parameters of Inhaled Drugs -- 8.6 Conclusion -- References -- 9 Oral Transmucosal Drug Delivery -- 9.1 Introduction -- 9.2 Structure and Physiology of the Oral Mucosa -- 9.3 Drug Properties Which Influence OTMD -- 9.4 Buccal and Sublingual Formulations -- 9.5 Models to Study OTDD -- 9.6 Feasibility of Systemic Delivery Based on In Vitro Permeation Studies -- 9.7 Conclusion -- References -- 10 PK/PD and the Drug Delivery Regimen for Infusion in the Critical Care Setting -- 10.1 Introduction.

10.2 PK/PD Properties and the Mode of Infusional Drug Delivery for Antibiotics -- 10.3 Changes in PK/PD and Infusional Drug Delivery Regimens in Critically Ill Patients -- 10.4 Short Intermittent Infusions -- 10.5 Extended Infusions -- 10.6 Continuous Infusion -- 10.7 Conclusions -- References -- 11 Virtual Experiment Methods for Integrating Pharmacokinetic, Pharmacodynamic, and Drug Delivery Mechanisms: Demonstrating Feasibility for Acetaminophen Hepatotoxicity -- 11.1 Introduction -- 11.2 Results -- 11.3 Methods -- 11.4 Discussion -- References -- 12 Personalized Medicine: Drug Delivery and Pharmacokinetics -- 12.1 Personalized Medicine -- 12.2 Drug Delivery in Personalized Medicine -- 12.3 Pharmacokinetic Analysis for Personalized Drug Delivery -- 12.4 Challenges and Opportunities in Personalized Drug Delivery -- 12.5 Conclusions -- References -- Index -- End User License Agreement.