{"product_id":"basics-and-clinical-applications-of-drug-disposition-in-special-populations-isbn-9781394251285","title":"Basics and Clinical Applications of Drug Disposition in Special Populations","description":"\u003cp\u003e\u003cb\u003eAn up-to-date exploration of techniques for effectively treating patients from special populations\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eIn \u003ci\u003eBasics and Clinical Applications of Drug Disposition in Special Populations,\u003c\/i\u003e a team of distinguished researchers delivers a timely and authoritative discussion of how to predict drug disposition in special populations, including people with obesity, pediatric patients, geriatric patients, and patients with renal and hepatic impairment. The authors use pharmacokinetic models to account for variabilities between populations and to better predict drug disposition. \u003c\/p\u003e\u003cp\u003eThe book offers a collection of 15 chapters written by recognized experts in their respective fields. They cover topics ranging from the optimization of drug dosing regimens in specialized populations to model-based approaches in drug treatment among pediatrics. \u003c\/p\u003e\u003cp\u003eReaders will also find: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA thorough introduction to considerations and regulatory affairs for clinical research in special populations\u003c\/li\u003e\n\u003cli\u003eComprehensive explorations of drug disposition in geriatrics, patients with hepatic insufficiency, and patients with renal insufficiency \u003c\/li\u003e\n\u003cli\u003ePractical discussions of model-based pharmacokinetic approaches\u003c\/li\u003e\n\u003cli\u003eComplete treatments of artificial intelligence in drug development\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for practicing pharmacologists, pharmacists, and clinical chemists, \u003ci\u003eBasics and Clinical Applications of Drug Disposition in Special Populations \u003c\/i\u003ewill also benefit medical professionals who provide medical and pharmaceutical care to special populations. \u003c\/p\u003e\u003cp\u003eAbout the Editors xxi\u003c\/p\u003e \u003cp\u003eList of Contributors xxiii\u003c\/p\u003e \u003cp\u003eForeword xxix\u003c\/p\u003e \u003cp\u003ePreface xxxi\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Pharmacokinetic Principles and Concepts: An Overview 1\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSeth K. Amponsah and Yahwant V. Pathak\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 Pharmacokinetic Parameters 2\u003c\/p\u003e \u003cp\u003e1.2.1 Absorption 2\u003c\/p\u003e \u003cp\u003e1.2.2 Distribution 3\u003c\/p\u003e \u003cp\u003e1.2.3 Metabolism 4\u003c\/p\u003e \u003cp\u003e1.2.4 Excretion 5\u003c\/p\u003e \u003cp\u003e1.3 Pharmacokinetic Models 5\u003c\/p\u003e \u003cp\u003e1.4 Applications 6\u003c\/p\u003e \u003cp\u003e1.5 Conclusion 7\u003c\/p\u003e \u003cp\u003eReferences 7\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Model-Based Pharmacokinetic Approaches 11\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eManish P. Patel, Kashyap M. Patel, Shakil Z. Vhora, Anuradha K. Gajjar, Jayvadan K. Patel, and Amitkumar K. Patel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 11\u003c\/p\u003e \u003cp\u003e2.1.1 Importance of PK 12\u003c\/p\u003e \u003cp\u003e2.1.2 Overview of Model-Based Approaches 13\u003c\/p\u003e \u003cp\u003e2.2 Basics of Pharmacokinetics 14\u003c\/p\u003e \u003cp\u003e2.2.1 Key Pharmacokinetic Parameters 14\u003c\/p\u003e \u003cp\u003e2.2.1.1 Absorption 14\u003c\/p\u003e \u003cp\u003e2.2.1.2 Key Parameter 14\u003c\/p\u003e \u003cp\u003e2.2.1.3 Distribution 14\u003c\/p\u003e \u003cp\u003e2.2.1.4 Key Parameter 15\u003c\/p\u003e \u003cp\u003e2.2.1.5 Metabolism 15\u003c\/p\u003e \u003cp\u003e2.2.1.6 Key Parameter 15\u003c\/p\u003e \u003cp\u003e2.2.1.7 Excretion 15\u003c\/p\u003e \u003cp\u003e2.2.1.8 Key Parameter 15\u003c\/p\u003e \u003cp\u003e2.2.2 Differences Between Traditional and Model-Based Pharmacokinetic Approaches 16\u003c\/p\u003e \u003cp\u003e2.3 Pharmacokinetic (PK) Models 17\u003c\/p\u003e \u003cp\u003e2.3.1 Introduction 17\u003c\/p\u003e \u003cp\u003e2.3.2 Compartment Modeling 18\u003c\/p\u003e \u003cp\u003e2.3.2.1 One-Compartment Model 21\u003c\/p\u003e \u003cp\u003e2.3.2.2 Multi-Compartment Model 21\u003c\/p\u003e \u003cp\u003e2.3.2.3 Two-Compartment Model 24\u003c\/p\u003e \u003cp\u003e2.3.3 Population PK Model 25\u003c\/p\u003e \u003cp\u003e2.3.4 Physiologically Based PK (PBPK) Model 26\u003c\/p\u003e \u003cp\u003e2.4 Model Development and Validation 27\u003c\/p\u003e \u003cp\u003e2.4.1 Data Requirements for Model Development 27\u003c\/p\u003e \u003cp\u003e2.4.2 Data Requirements for Model Validation 29\u003c\/p\u003e \u003cp\u003e2.4.3 Steps in Model Building (E.g., Model Selection and Parameter Estimation) 29\u003c\/p\u003e \u003cp\u003e2.5 Applications of Model-Based Approaches 31\u003c\/p\u003e \u003cp\u003e2.5.1 Dose Optimization 31\u003c\/p\u003e \u003cp\u003e2.5.2 Predicting Drug Interactions 32\u003c\/p\u003e \u003cp\u003e2.5.3 Drug Tailoring in Special Populations (E.g., Pediatrics, Geriatrics, and Renal Impairment) 33\u003c\/p\u003e \u003cp\u003e2.5.4 Translational PK from Preclinical to Clinical Settings 34\u003c\/p\u003e \u003cp\u003e2.6 Modeling in Special Populations 36\u003c\/p\u003e \u003cp\u003e2.6.1 Challenges and Considerations 36\u003c\/p\u003e \u003cp\u003e2.6.1.1 Challenges in PK Modeling 36\u003c\/p\u003e \u003cp\u003e2.6.1.2 Considerations in PK Modeling 36\u003c\/p\u003e \u003cp\u003e2.7 Software and Tools for PK Modeling 37\u003c\/p\u003e \u003cp\u003e2.7.1 Gastroplus™ 38\u003c\/p\u003e \u003cp\u003e2.7.2 Berkeley Madonna 38\u003c\/p\u003e \u003cp\u003e2.7.3 MATLAB 38\u003c\/p\u003e \u003cp\u003e2.7.4 PK-Sim® 39\u003c\/p\u003e \u003cp\u003e2.7.5 Simcyp® 39\u003c\/p\u003e \u003cp\u003e2.7.6 Auxiliary PBPK Modeling Software 39\u003c\/p\u003e \u003cp\u003e2.7.6.1 Julia 39\u003c\/p\u003e \u003cp\u003e2.7.6.2 Nonmem 39\u003c\/p\u003e \u003cp\u003e2.7.6.3 Phoenix WinNonlin 40\u003c\/p\u003e \u003cp\u003e2.7.6.4 GraphPad Prism 40\u003c\/p\u003e \u003cp\u003e2.7.6.5 Minitab 40\u003c\/p\u003e \u003cp\u003e2.7.6.6 PlotDigitizer 40\u003c\/p\u003e \u003cp\u003e2.7.6.7 GNU MCSim 40\u003c\/p\u003e \u003cp\u003e2.7.6.8 WebPlotDigitizer 40\u003c\/p\u003e \u003cp\u003e2.8 Regulatory Perspectives of PK Modeling 40\u003c\/p\u003e \u003cp\u003e2.9 Future Directions of PK Modeling 43\u003c\/p\u003e \u003cp\u003e2.10 Conclusion 43\u003c\/p\u003e \u003cp\u003eAbbreviations 44\u003c\/p\u003e \u003cp\u003eReferences 45\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Physiologically Based Pharmacokinetic Modeling 53\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMahesh P. More and Rahul S. Tade\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 53\u003c\/p\u003e \u003cp\u003e3.2 Significance of PBPK Modeling 56\u003c\/p\u003e \u003cp\u003e3.3 Principles for the Development of PBPK for Special Populations 57\u003c\/p\u003e \u003cp\u003e3.4 Data Integration for Special Populations 57\u003c\/p\u003e \u003cp\u003e3.4.1 Demographic Data 58\u003c\/p\u003e \u003cp\u003e3.4.2 Physiological Consideration 58\u003c\/p\u003e \u003cp\u003e3.4.3 Ontogeny 58\u003c\/p\u003e \u003cp\u003e3.4.4 Age and Maturation Changes 59\u003c\/p\u003e \u003cp\u003e3.4.5 Steady State Volume of Distribution (Vdss) 59\u003c\/p\u003e \u003cp\u003e3.5 Applications of PBPK Modeling 60\u003c\/p\u003e \u003cp\u003e3.5.1 Dose Optimization\/Regimen\/Selection 60\u003c\/p\u003e \u003cp\u003e3.5.2 Dose Individualization\/Precision Dosing 61\u003c\/p\u003e \u003cp\u003e3.5.3 Biopharmaceutics 62\u003c\/p\u003e \u003cp\u003e3.6 Regulatory Applications\/Pre–Post Market Utilization 62\u003c\/p\u003e \u003cp\u003e3.7 Case Studies 64\u003c\/p\u003e \u003cp\u003e3.7.1 Simulation Application 64\u003c\/p\u003e \u003cp\u003e3.7.2 Successful Applications 67\u003c\/p\u003e \u003cp\u003e3.8 Lessons Learned 68\u003c\/p\u003e \u003cp\u003e3.9 Conclusion 68\u003c\/p\u003e \u003cp\u003eReferences 70\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Therapeutic Drug Monitoring in Special Populations 75\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJames A. Akingbasote, Sandra K. Szlapinski, Elora Hilmas, Kyle Weston, Yelena Wu, and Alexandra Burton\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 75\u003c\/p\u003e \u003cp\u003e4.2 Pediatrics 76\u003c\/p\u003e \u003cp\u003e4.2.1 Importance of TDM in Pediatrics 76\u003c\/p\u003e \u003cp\u003e4.2.2 Pharmacokinetic Differences in Pediatric Patients 77\u003c\/p\u003e \u003cp\u003e4.2.3 Drug Absorption in the Pediatric Population 77\u003c\/p\u003e \u003cp\u003e4.2.4 Drug Distribution in the Pediatric Population 78\u003c\/p\u003e \u003cp\u003e4.2.5 Drug Metabolism and Elimination in the Pediatric Population 79\u003c\/p\u003e \u003cp\u003e4.3 TDM Practices in Pediatrics 79\u003c\/p\u003e \u003cp\u003e4.3.1 Vancomycin 80\u003c\/p\u003e \u003cp\u003e4.3.2 Aminoglycosides 81\u003c\/p\u003e \u003cp\u003e4.3.3 Ganciclovir\/Valganciclovir 82\u003c\/p\u003e \u003cp\u003e4.3.4 Antiepileptic Drugs (AEDs) 83\u003c\/p\u003e \u003cp\u003e4.3.5 Enoxaparin 84\u003c\/p\u003e \u003cp\u003e4.4 Conclusion 85\u003c\/p\u003e \u003cp\u003e4.5 Pregnancy 85\u003c\/p\u003e \u003cp\u003e4.5.1 Physiological Adaptations in Pregnancy 85\u003c\/p\u003e \u003cp\u003e4.5.2 Current State of Clinical Practice of TDM in Pregnancy 87\u003c\/p\u003e \u003cp\u003e4.5.3 TDM in Pregnancy 89\u003c\/p\u003e \u003cp\u003e4.5.3.1 Antiepileptics 89\u003c\/p\u003e \u003cp\u003e4.5.3.2 Antidepressants 90\u003c\/p\u003e \u003cp\u003e4.5.3.3 Antiretroviral Drugs 91\u003c\/p\u003e \u003cp\u003e4.5.3.4 Immunomodulatory Drugs 93\u003c\/p\u003e \u003cp\u003e4.5.4 Challenges in the Implementation of TDM in the Pregnant Population 94\u003c\/p\u003e \u003cp\u003e4.6 The Elderly 95\u003c\/p\u003e \u003cp\u003e4.6.1 Physiological Changes in the Elderly 95\u003c\/p\u003e \u003cp\u003e4.6.2 Effect of Aging on Drug Pharmacokinetics 95\u003c\/p\u003e \u003cp\u003e4.6.3 Application of TDM in the Elderly 97\u003c\/p\u003e \u003cp\u003e4.6.3.1 Cardiac Glycosides 98\u003c\/p\u003e \u003cp\u003e4.6.3.2 Serotonin–Norepinephrine Reuptake Inhibitor (SNRI) 98\u003c\/p\u003e \u003cp\u003e4.6.3.3 Anticoagulants 99\u003c\/p\u003e \u003cp\u003e4.6.3.4 Benzodiazepines 99\u003c\/p\u003e \u003cp\u003e4.7 Conclusion 101\u003c\/p\u003e \u003cp\u003e4.8 Hepatic and Renal Impairments 101\u003c\/p\u003e \u003cp\u003e4.8.1 Hepatic Impairment 102\u003c\/p\u003e \u003cp\u003e4.8.2 TDM in Patients with Hepatic Impairment 104\u003c\/p\u003e \u003cp\u003e4.8.2.1 Meropenem 105\u003c\/p\u003e \u003cp\u003e4.8.2.2 Metoprolol 105\u003c\/p\u003e \u003cp\u003e4.8.2.3 Midazolam 106\u003c\/p\u003e \u003cp\u003e4.8.3 Renal Impairment 107\u003c\/p\u003e \u003cp\u003e4.8.4 Prerenal Disease 109\u003c\/p\u003e \u003cp\u003e4.8.5 Intrinsic Renal Vascular Disease 109\u003c\/p\u003e \u003cp\u003e4.8.6 Intrinsic Glomerular Disease (Nephritic or Nephrotic) 109\u003c\/p\u003e \u003cp\u003e4.8.7 TDM in Renal Impairment 109\u003c\/p\u003e \u003cp\u003e4.8.7.1 Vancomycin 111\u003c\/p\u003e \u003cp\u003e4.8.7.2 Metformin 111\u003c\/p\u003e \u003cp\u003e4.9 Conclusion 112\u003c\/p\u003e \u003cp\u003e4.10 Overall Conclusion and Future Direction 112\u003c\/p\u003e \u003cp\u003eAcknowledgment 113\u003c\/p\u003e \u003cp\u003eReferences 114\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Optimization of Drug Dosing Regimen 133\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eVivek Patel, Kartik Hariharan, Dhruv Shah, Arindam Halder, Ajay J. Khopade, Amitkumar K. Patel, and Jayvadan K. Patel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 133\u003c\/p\u003e \u003cp\u003e5.2 Dosing Regimen Optimization Approaches and Strategies 134\u003c\/p\u003e \u003cp\u003e5.2.1 Models Used for Dosing Regimen Selection 134\u003c\/p\u003e \u003cp\u003e5.2.1.1 Pharmacometric Models 134\u003c\/p\u003e \u003cp\u003e5.2.1.2 PK Models 135\u003c\/p\u003e \u003cp\u003e5.2.1.3 Empirical Dose–Response Models 136\u003c\/p\u003e \u003cp\u003e5.2.1.4 Multiple Comparison Procedures Models (MCP-Mod) 136\u003c\/p\u003e \u003cp\u003e5.2.1.5 Model Averaging 137\u003c\/p\u003e \u003cp\u003e5.2.2 Role of Patient Characteristics in Dose Selection 137\u003c\/p\u003e \u003cp\u003e5.2.2.1 Phenotype-Guided Dosing 137\u003c\/p\u003e \u003cp\u003e5.2.2.2 Genotype-Guided Drug Dosing 138\u003c\/p\u003e \u003cp\u003e5.2.3 Therapeutic Drug Monitoring (TDM) 138\u003c\/p\u003e \u003cp\u003e5.3 Dosing Regimen in Special Populations 139\u003c\/p\u003e \u003cp\u003e5.3.1 Dosing Regimen in Cancer Patients 139\u003c\/p\u003e \u003cp\u003e5.3.1.1 Metronomic Chemotherapy 140\u003c\/p\u003e \u003cp\u003e5.3.2 Dosing Regimen for Patients on Antimicrobial Therapy 142\u003c\/p\u003e \u003cp\u003e5.3.2.1 Antimicrobial Stewardship Strategy 145\u003c\/p\u003e \u003cp\u003e5.3.2.2 Mathematical Models for Optimizing Antimicrobial Therapy 146\u003c\/p\u003e \u003cp\u003e5.3.2.3 Antimicrobial Dosing Strategies During CRRT 147\u003c\/p\u003e \u003cp\u003e5.3.2.4 Methods for Enhancing Dosing of Antimicrobials via Nebulization 149\u003c\/p\u003e \u003cp\u003e5.3.3 Dosing Regimen in Pediatric Patients 149\u003c\/p\u003e \u003cp\u003e5.3.3.1 Physiological Differences Between Pediatric and Adult Patients 149\u003c\/p\u003e \u003cp\u003e5.3.3.2 Application of MIDD in Pediatric Dose Selection 149\u003c\/p\u003e \u003cp\u003e5.3.3.3 Scaling from Adults to Pediatric Patients 150\u003c\/p\u003e \u003cp\u003e5.3.3.4 Scaling from Animals to Pediatric Patients 150\u003c\/p\u003e \u003cp\u003e5.3.3.5 Integrating Mechanistic Models in Neonates and Infants 150\u003c\/p\u003e \u003cp\u003e5.3.3.6 Dose Optimization in Neonates and Infants 151\u003c\/p\u003e \u003cp\u003e5.4 Conclusion 151\u003c\/p\u003e \u003cp\u003eReferences 152\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Artificial Intelligence in Drug Development 161\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSurovi Saikia, Aparna Anandan, Unais Annenkottil, Vishnu P. Athilingam, Partha P. Kalita, and Viswanadha V. Padma\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 161\u003c\/p\u003e \u003cp\u003e6.2 Application of AI in Drug Design 162\u003c\/p\u003e \u003cp\u003e6.2.1 Target Identification and Validation 162\u003c\/p\u003e \u003cp\u003e6.2.2 Drug Candidate Design and Optimization 162\u003c\/p\u003e \u003cp\u003e6.2.3 Virtual Screening and Molecular Docking 163\u003c\/p\u003e \u003cp\u003e6.2.4 Synthesis Planning 163\u003c\/p\u003e \u003cp\u003e6.2.5 Predicting Drug Toxicity and Pharmacokinetics 163\u003c\/p\u003e \u003cp\u003e6.2.6 Personalized Medicine 163\u003c\/p\u003e \u003cp\u003e6.3 AI Use in Drug Formulation 163\u003c\/p\u003e \u003cp\u003e6.4 Drug Release Characterization Using AI 164\u003c\/p\u003e \u003cp\u003e6.5 AI-Based Dose\/Dosing Regimen 165\u003c\/p\u003e \u003cp\u003e6.6 Dissolution Rate Predictions with AI 166\u003c\/p\u003e \u003cp\u003e6.7 Clinical End-Point Evaluation with AI 166\u003c\/p\u003e \u003cp\u003e6.8 AI in Prediction of Fate of Drugs Administered Via Mucosal, Transdermal, and Parenteral Routes 167\u003c\/p\u003e \u003cp\u003e6.9 AI-Integrated Mechanistic Modeling Platform for Drug Delivery and Monitoring 169\u003c\/p\u003e \u003cp\u003e6.10 AI-Based Tools for Metabolism and Clearance Prediction 169\u003c\/p\u003e \u003cp\u003e6.11 Limitations of Existing Tools 171\u003c\/p\u003e \u003cp\u003e6.12 Conclusions 171\u003c\/p\u003e \u003cp\u003e6.13 Conflict of Interest 171\u003c\/p\u003e \u003cp\u003eAcknowledgments 171\u003c\/p\u003e \u003cp\u003eReferences 172\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Drug Disposition in Neonates and Infants 179\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDavid Gyamfi, Emmanuel B. Amoafo, Awo A. Kwapong, Mansa Fredua-Agyeman, and Seth K. Amponsah\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 179\u003c\/p\u003e \u003cp\u003e7.2 Drug Absorption in Neonates and Infants 180\u003c\/p\u003e \u003cp\u003e7.3 Drug Distribution in Neonates and Infants 182\u003c\/p\u003e \u003cp\u003e7.4 Hepatic Metabolism of Drugs in Neonates and Infants 185\u003c\/p\u003e \u003cp\u003e7.4.1 Phase I Metabolism 185\u003c\/p\u003e \u003cp\u003e7.4.2 Phase II Metabolism 187\u003c\/p\u003e \u003cp\u003e7.5 Drug Excretion in Neonates and Infants 188\u003c\/p\u003e \u003cp\u003e7.6 Pharmacodynamics in Neonates and Infants 190\u003c\/p\u003e \u003cp\u003e7.7 Age-Related Dosing Regimen in Neonates and Infants 190\u003c\/p\u003e \u003cp\u003e7.8 Conclusion 192\u003c\/p\u003e \u003cp\u003eReferences 193\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Drug Disposition in Adolescents 203\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAparoop Das, Kalyani Pathak, Riya Saikia, Manash P. Pathak, Urvashee Gogoi, Jon J. Sahariah, Dibyajyoti Das, Md Ariful Islam, and Pallab Pramanik\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 203\u003c\/p\u003e \u003cp\u003e8.2 Physiological Considerations in Adolescents 206\u003c\/p\u003e \u003cp\u003e8.2.1 Organ Development: Liver and Kidney Maturation 206\u003c\/p\u003e \u003cp\u003e8.2.2 Variations in Body Composition 208\u003c\/p\u003e \u003cp\u003e8.2.3 Hormonal Changes 208\u003c\/p\u003e \u003cp\u003e8.2.3.1 Males 208\u003c\/p\u003e \u003cp\u003e8.2.3.2 Females 209\u003c\/p\u003e \u003cp\u003e8.2.4 Other Physiological Changes 210\u003c\/p\u003e \u003cp\u003e8.3 Medication Adherence Challenges in Adolescents 211\u003c\/p\u003e \u003cp\u003e8.4 Psychological Development on Drug Disposition 212\u003c\/p\u003e \u003cp\u003e8.5 Risk-Taking behaviors and Their Implications on Medication Use 213\u003c\/p\u003e \u003cp\u003e8.6 Drug Use Among Adolescents 215\u003c\/p\u003e \u003cp\u003e8.6.1 Acetaminophen Use in Adolescents 215\u003c\/p\u003e \u003cp\u003e8.6.2 Antidepressant Use in Adolescents 215\u003c\/p\u003e \u003cp\u003e8.6.3 Drugs for ADHD 216\u003c\/p\u003e \u003cp\u003e8.7 Pharmacokinetic Variability in Adolescents Drug Examples 217\u003c\/p\u003e \u003cp\u003e8.7.1 Acetaminophen 217\u003c\/p\u003e \u003cp\u003e8.7.2 Theophylline 217\u003c\/p\u003e \u003cp\u003e8.7.3 Antidepressants 218\u003c\/p\u003e \u003cp\u003e8.7.4 Drugs for ADHD 218\u003c\/p\u003e \u003cp\u003e8.8 Legal and Ethical Considerations 219\u003c\/p\u003e \u003cp\u003e8.8.1 Consent and Confidentiality in Adolescent Healthcare 219\u003c\/p\u003e \u003cp\u003e8.8.2 Involving Adolescents in Treatment Decisions 220\u003c\/p\u003e \u003cp\u003e8.8.3 Regulatory Aspects of Adolescents Drug Prescribing 221\u003c\/p\u003e \u003cp\u003e8.9 Conclusion 221\u003c\/p\u003e \u003cp\u003eReferences 222\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Drug Disposition in Pregnancy 229\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJacob Treanor, Stefanos Belavilas, Dominique Cook, Justin Cole, Amruta Potdar, and Charles Preuss\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 229\u003c\/p\u003e \u003cp\u003e9.2 Physiological Changes in Pregnancy 230\u003c\/p\u003e \u003cp\u003e9.2.1 Changes in Absorption 231\u003c\/p\u003e \u003cp\u003e9.2.2 Changes in Distribution and Free Medication 231\u003c\/p\u003e \u003cp\u003e9.2.3 Changes in Cytochrome Metabolism 233\u003c\/p\u003e \u003cp\u003e9.2.4 Changes in Renal Excretion 233\u003c\/p\u003e \u003cp\u003e9.2.5 General Considerations in Drug Dosing with Pregnancy 234\u003c\/p\u003e \u003cp\u003e9.3 Placental Drug Disposition 234\u003c\/p\u003e \u003cp\u003e9.3.1 Placental Barrier Anatomy and Physiology 235\u003c\/p\u003e \u003cp\u003e9.3.2 Placental Transport Mechanisms 237\u003c\/p\u003e \u003cp\u003e9.3.3 Methods of Study for Placental Drug Transfer 238\u003c\/p\u003e \u003cp\u003e9.4 Drug Classification in Pregnancy 239\u003c\/p\u003e \u003cp\u003e9.5 Pharmacokinetic (PK) Modeling 241\u003c\/p\u003e \u003cp\u003e9.6 Physiologically Based Pharmacokinetic (PBPK) Modeling 242\u003c\/p\u003e \u003cp\u003e9.7 Limitations in PK and PBPK Models 244\u003c\/p\u003e \u003cp\u003e9.8 PBPK Model Variables 244\u003c\/p\u003e \u003cp\u003e9.9 Determining Treatment During Pregnancy 245\u003c\/p\u003e \u003cp\u003e9.10 Fetal Blood Flow and Drug Processing 245\u003c\/p\u003e \u003cp\u003e9.10.1 Hepatic and Renal Processing 246\u003c\/p\u003e \u003cp\u003e9.10.2 Embryonic Staging 248\u003c\/p\u003e \u003cp\u003e9.11 Teratogens 249\u003c\/p\u003e \u003cp\u003e9.11.1 Thalidomide 250\u003c\/p\u003e \u003cp\u003e9.11.2 Alcohol 251\u003c\/p\u003e \u003cp\u003e9.11.3 Smoking and E-cigarettes 251\u003c\/p\u003e \u003cp\u003e9.11.4 Caffeine 252\u003c\/p\u003e \u003cp\u003e9.11.5 Antibiotics 253\u003c\/p\u003e \u003cp\u003e9.11.6 Retinoids 254\u003c\/p\u003e \u003cp\u003e9.12 Conclusion 257\u003c\/p\u003e \u003cp\u003eAbbreviations 257\u003c\/p\u003e \u003cp\u003eReferences 258\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Drug Disposition in Obesity 265\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSeema Kohli and Ankita A. Singh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 265\u003c\/p\u003e \u003cp\u003e10.2 Index of Obesity 265\u003c\/p\u003e \u003cp\u003e10.3 Pathogenesis of Obesity\/Overweight 266\u003c\/p\u003e \u003cp\u003e10.4 Drug Disposition in Obesity 267\u003c\/p\u003e \u003cp\u003e10.4.1 Absorption 267\u003c\/p\u003e \u003cp\u003e10.4.2 Distribution 268\u003c\/p\u003e \u003cp\u003e10.4.3 Metabolism 268\u003c\/p\u003e \u003cp\u003e10.4.4 Renal Excretion 270\u003c\/p\u003e \u003cp\u003e10.5 Drug Dose Calculations in Obese Patients 270\u003c\/p\u003e \u003cp\u003e10.5.1 Volume of Distribution (Vd) 270\u003c\/p\u003e \u003cp\u003e10.5.2 Drug Clearance 271\u003c\/p\u003e \u003cp\u003e10.5.3 Body Size Description 271\u003c\/p\u003e \u003cp\u003e10.5.4 Drug Dose Calculation 272\u003c\/p\u003e \u003cp\u003e10.6 Disposition of Drugs in Obesity 273\u003c\/p\u003e \u003cp\u003e10.6.1 Volatile Agents 273\u003c\/p\u003e \u003cp\u003e10.6.2 Thiopental 274\u003c\/p\u003e \u003cp\u003e10.6.3 Propofol 274\u003c\/p\u003e \u003cp\u003e10.6.4 Midazolam 274\u003c\/p\u003e \u003cp\u003e10.6.5 Acetaminophen 274\u003c\/p\u003e \u003cp\u003e10.6.6 Opioids 275\u003c\/p\u003e \u003cp\u003e10.6.7 Unfractionated Heparin 275\u003c\/p\u003e \u003cp\u003e10.6.8 Cephazolin 275\u003c\/p\u003e \u003cp\u003e10.6.9 Enoxaparin 275\u003c\/p\u003e \u003cp\u003e10.7 Conclusion 276\u003c\/p\u003e \u003cp\u003eReferences 276\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Drug Disposition in Critical Care Patients 281\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eChinenye E. Muolokwu, Benjamin Tagoe, Michael M. Attah, and Seth K. Amponsah\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 281\u003c\/p\u003e \u003cp\u003e11.2 Pharmacokinetic Considerations in Critical Care Patients 282\u003c\/p\u003e \u003cp\u003e11.2.1 Drug Absorption Considerations in Critical Care Patients 282\u003c\/p\u003e \u003cp\u003e11.2.2 Drug Distribution Considerations in Critical Care Patients 283\u003c\/p\u003e \u003cp\u003e11.2.3 Drug Metabolism Considerations in Critical Care Patients 284\u003c\/p\u003e \u003cp\u003e11.2.4 Drug Excretion Considerations in Critical Care Patients 285\u003c\/p\u003e \u003cp\u003e11.3 Dosing Algorithms for Commonly Administered Drugs in Critical Care Patients 286\u003c\/p\u003e \u003cp\u003e11.3.1 Antibacterial and Antifungal Agents 286\u003c\/p\u003e \u003cp\u003e11.3.1.1 Aminoglycosides 287\u003c\/p\u003e \u003cp\u003e11.3.1.2 β-Lactam Antibiotics 288\u003c\/p\u003e \u003cp\u003e11.3.1.3 Fluoroquinolones 288\u003c\/p\u003e \u003cp\u003e11.3.1.4 Oxazolidinones 289\u003c\/p\u003e \u003cp\u003e11.3.1.5 Antifungal Agents 289\u003c\/p\u003e \u003cp\u003e11.3.2 Inotropes 291\u003c\/p\u003e \u003cp\u003e11.3.3 Antiviral Drugs 292\u003c\/p\u003e \u003cp\u003e11.3.4 Narcotic Analgesics 292\u003c\/p\u003e \u003cp\u003e11.3.4.1 Morphine and Pethidine 292\u003c\/p\u003e \u003cp\u003e11.3.4.2 Fentanyl and Derivatives 293\u003c\/p\u003e \u003cp\u003e11.3.5 Sedatives and Hypnotics 293\u003c\/p\u003e \u003cp\u003e11.3.5.1 Midazolam 294\u003c\/p\u003e \u003cp\u003e11.3.5.2 Lorazepam 295\u003c\/p\u003e \u003cp\u003e11.3.6 Neuromuscular Blockers 295\u003c\/p\u003e \u003cp\u003e11.4 Conclusion 297\u003c\/p\u003e \u003cp\u003eReferences 297\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Drug Disposition in Renal Insufficiency 305\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Nestler, Deborah Liaw, Gabriella Blanco, Rana Hanna, Ellen Si, and Charles Preuss\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Renal Physiology 305\u003c\/p\u003e \u003cp\u003e12.1.1 General Anatomical Structure 305\u003c\/p\u003e \u003cp\u003e12.1.2 General Function of the Nephron 306\u003c\/p\u003e \u003cp\u003e12.1.3 Water Regulation 306\u003c\/p\u003e \u003cp\u003e12.1.4 Glomerular Filtration Rate (GFR) 307\u003c\/p\u003e \u003cp\u003e12.1.5 Acid–Base Regulation 307\u003c\/p\u003e \u003cp\u003e12.2 Glomerular Filtration Rate 307\u003c\/p\u003e \u003cp\u003e12.3 Acute Kidney Injury 308\u003c\/p\u003e \u003cp\u003e12.3.1 Diagnostic Criteria and Classification 308\u003c\/p\u003e \u003cp\u003e12.3.2 Causes of AKI 310\u003c\/p\u003e \u003cp\u003e12.3.3 Prerenal 310\u003c\/p\u003e \u003cp\u003e12.3.4 Intrinsic 310\u003c\/p\u003e \u003cp\u003e12.3.5 Postrenal 311\u003c\/p\u003e \u003cp\u003e12.4 Chronic Kidney Disease 311\u003c\/p\u003e \u003cp\u003e12.4.1 Diagnostic Criteria and Classification 311\u003c\/p\u003e \u003cp\u003e12.4.2 Causes of Chronic Kidney Disease 312\u003c\/p\u003e \u003cp\u003e12.5 Medication Dosing Modifications 313\u003c\/p\u003e \u003cp\u003e12.5.1 Medication Dosing in Patients with CKD 313\u003c\/p\u003e \u003cp\u003e12.5.2 Medications to Treat CKD-Induced HTN and Medications to Avoid in CKD 314\u003c\/p\u003e \u003cp\u003e12.5.2.1 Antihypertensives 314\u003c\/p\u003e \u003cp\u003e12.5.2.2 Hypoglycemics 316\u003c\/p\u003e \u003cp\u003e12.5.2.3 Antimicrobials 317\u003c\/p\u003e \u003cp\u003e12.5.2.4 Statins 321\u003c\/p\u003e \u003cp\u003e12.5.2.5 NSAIDs 322\u003c\/p\u003e \u003cp\u003e12.5.2.6 Analgesics 322\u003c\/p\u003e \u003cp\u003e12.6 Epidemiology and Outcomes of Patients with CKD 323\u003c\/p\u003e \u003cp\u003eReferences 324\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Drug Disposition in Hepatic Insufficiency 327\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eFried A. Abilba, Jacob A. Ayembilla, and Raphael N. Alolga\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 327\u003c\/p\u003e \u003cp\u003e13.2 The Spectrum of Liver Diseases 328\u003c\/p\u003e \u003cp\u003e13.3 Liver Function and Drug Metabolism 330\u003c\/p\u003e \u003cp\u003e13.3.1 Impact of Hepatic Insufficiency on Drug Metabolism 331\u003c\/p\u003e \u003cp\u003e13.3.2 Pharmacokinetic Changes in Hepatic Insufficiency 332\u003c\/p\u003e \u003cp\u003e13.3.3 Effect of Liver Diseases on Pharmacokinetics of Drugs 333\u003c\/p\u003e \u003cp\u003e13.4 Dosing Algorithms in Clinical Practice 334\u003c\/p\u003e \u003cp\u003e13.4.1 Drug Selection 335\u003c\/p\u003e \u003cp\u003e13.4.2 Dosing Adjustments 336\u003c\/p\u003e \u003cp\u003e13.4.3 Pharmacokinetic Considerations 336\u003c\/p\u003e \u003cp\u003e13.5 Drug Disposition and Factors That Influence Drug Disposition 336\u003c\/p\u003e \u003cp\u003e13.6 Major Classes of Drugs and Hepatic Insufficiency 337\u003c\/p\u003e \u003cp\u003e13.6.1 Anticoagulants 337\u003c\/p\u003e \u003cp\u003e13.6.2 Antibiotics 338\u003c\/p\u003e \u003cp\u003e13.6.3 Analgesics 338\u003c\/p\u003e \u003cp\u003e13.6.4 Anticonvulsants 338\u003c\/p\u003e \u003cp\u003e13.6.5 Antidepressants 339\u003c\/p\u003e \u003cp\u003e13.6.6 Antiretrovirals 339\u003c\/p\u003e \u003cp\u003e13.7 Cases Demonstrating Application of Dosing Algorithms 339\u003c\/p\u003e \u003cp\u003e13.7.1 Case 1: Warfarin for Anticoagulation 339\u003c\/p\u003e \u003cp\u003e13.7.1.1 The Use of Warfarin in a Patient with Hereditary Bleeding Disorder 339\u003c\/p\u003e \u003cp\u003e13.7.1.2 Dosing Algorithm of Warfarin 340\u003c\/p\u003e \u003cp\u003e13.7.2 Case 2: Acetaminophen for Pain Management 340\u003c\/p\u003e \u003cp\u003e13.7.2.1 Dosing Algorithm for Paracetamol and Other Cytochrome p 450\u003c\/p\u003e \u003cp\u003eEnzyme-inducing Drugs in Hepatic Insufficiency Using Child-Pugh Score 341\u003c\/p\u003e \u003cp\u003e13.7.3 Case 3: Valproic Acid for Seizure Control 341\u003c\/p\u003e \u003cp\u003e13.7.4 Case 4: Metronidazole for Infection 342\u003c\/p\u003e \u003cp\u003e13.7.5 Case 5: Efavirenz for HIV Treatment 342\u003c\/p\u003e \u003cp\u003e13.8 Limitations of Current Dosing Strategies 342\u003c\/p\u003e \u003cp\u003e13.9 Conclusion and Future Perspectives 343\u003c\/p\u003e \u003cp\u003e13.9.1 Emerging Technologies and Precision Medicine 343\u003c\/p\u003e \u003cp\u003e13.9.2 Potential Impact of Pharmacogenomics 344\u003c\/p\u003e \u003cp\u003e13.9.3 Areas of Research Interest 344\u003c\/p\u003e \u003cp\u003eReferences 345\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Drug Disposition in Geriatrics 349\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAli Karimi, Samuel Cockey, Millena Levin, Teresa Travnicek, Nishanth Chalasani, and Charles Preuss\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 349\u003c\/p\u003e \u003cp\u003e14.2 Absorption 351\u003c\/p\u003e \u003cp\u003e14.3 Distribution 352\u003c\/p\u003e \u003cp\u003e14.4 Metabolism 354\u003c\/p\u003e \u003cp\u003e14.5 Excretion 356\u003c\/p\u003e \u003cp\u003e14.6 Hepatic 360\u003c\/p\u003e \u003cp\u003e14.7 Renal 361\u003c\/p\u003e \u003cp\u003e14.8 Cardiac 363\u003c\/p\u003e \u003cp\u003e14.9 Sex Differences 363\u003c\/p\u003e \u003cp\u003e14.10 Psychoactive Drugs 365\u003c\/p\u003e \u003cp\u003e14.11 Anesthesiology Drugs 366\u003c\/p\u003e \u003cp\u003e14.12 Drug Interactions 367\u003c\/p\u003e \u003cp\u003e14.13 Drug Side Effects 368\u003c\/p\u003e \u003cp\u003e14.14 Conclusion 371\u003c\/p\u003e \u003cp\u003eAbbreviations 372\u003c\/p\u003e \u003cp\u003eReferences 373\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Considerations and Regulatory Affairs for Clinical Research in Special Populations 377\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eStephanie Leigh, Maxine Turner, and Goonaseelan C. Pillai\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 377\u003c\/p\u003e \u003cp\u003e15.2 Regulatory Frameworks for Clinical Research in Special Populations 378\u003c\/p\u003e \u003cp\u003e15.2.1 The Historical Evolution of Regulatory Frameworks for Special Population Research 378\u003c\/p\u003e \u003cp\u003e15.2.2 Current Global Regulatory Frameworks for Special Population Research 380\u003c\/p\u003e \u003cp\u003e15.2.3 Current Regional Regulations Concerning Clinical Research Involving Special Populations 382\u003c\/p\u003e \u003cp\u003e15.2.3.1 The United States: Food and Drug Regulatory Authority (us Fda) 382\u003c\/p\u003e \u003cp\u003e15.2.3.2 Europe: European Medicines Agency (EMA) 383\u003c\/p\u003e \u003cp\u003e15.2.3.3 The United Kingdom: The Medicines and Healthcare Products Regulatory Agency (MHRA) 383\u003c\/p\u003e \u003cp\u003e15.2.3.4 Australia: The Therapeutic Goods Administration (TGA) 384\u003c\/p\u003e \u003cp\u003e15.2.3.5 Brazil: National Health Surveillance Agency (ANVISA) 385\u003c\/p\u003e \u003cp\u003e15.2.3.6 India: Central Drugs Standard Control Organization (CDSCO) 387\u003c\/p\u003e \u003cp\u003e15.2.3.7 China: National Medical Products Administration (NMPA) 388\u003c\/p\u003e \u003cp\u003e15.2.3.8 South Africa: The South African Health Products Regulatory Authority (SAHPRA) 389\u003c\/p\u003e \u003cp\u003e15.2.4 Holistic Analysis of Regional Regulations Concerning Clinical Research Involving Special Populations 391\u003c\/p\u003e \u003cp\u003e15.3 Key Considerations for Clinical Trials in Special Population Groups 392\u003c\/p\u003e \u003cp\u003e15.3.1 Pediatric Population Groups 392\u003c\/p\u003e \u003cp\u003e15.3.1.1 Regulatory Guidelines Governing Pediatric Clinical Research 392\u003c\/p\u003e \u003cp\u003e15.3.2 Regional Legislations Governing Clinical Research in Pediatric Populations 393\u003c\/p\u003e \u003cp\u003e15.3.2.1 The United States: Food and Drug Regulatory Authority (us Fda) 393\u003c\/p\u003e \u003cp\u003e15.3.2.2 Europe: European Medicines Agency (EMA) 395\u003c\/p\u003e \u003cp\u003e15.3.2.3 The United Kingdom: The Medicines and Healthcare Products Regulatory Agency (MHRA) 396\u003c\/p\u003e \u003cp\u003e15.3.2.4 India: Central Drugs Standard Control Organization (CDSCO) 396\u003c\/p\u003e \u003cp\u003e15.3.2.5 Other Global Jurisdictions 397\u003c\/p\u003e \u003cp\u003e15.3.3 Holistic Analysis of Regional Regulations Concerning Clinical Research Involving Pediatric Populations 398\u003c\/p\u003e \u003cp\u003e15.3.4 Ethical Considerations for Clinical Research in Pediatric Populations 398\u003c\/p\u003e \u003cp\u003e15.3.4.1 Assent and Informed Consent 399\u003c\/p\u003e \u003cp\u003e15.3.4.2 Participant Recruitment 402\u003c\/p\u003e \u003cp\u003e15.4 Pregnant Population Groups 403\u003c\/p\u003e \u003cp\u003e15.4.1 Historical Exclusion of Pregnant Persons in Clinical Research 403\u003c\/p\u003e \u003cp\u003e15.4.2 Regulatory Guidelines Governing Clinical Research in Pregnant Persons 404\u003c\/p\u003e \u003cp\u003e15.4.3 Regional Legislations Governing Clinical Research in Pregnant Persons 406\u003c\/p\u003e \u003cp\u003e15.4.3.1 The United States: Food and Drug Regulatory Authority (us Fda) 406\u003c\/p\u003e \u003cp\u003e15.4.3.2 Europe: European Medicines Agency (EMA) 406\u003c\/p\u003e \u003cp\u003e15.4.3.3 Australia: The Therapeutic Goods Administration (TGA) 407\u003c\/p\u003e \u003cp\u003e15.4.3.4 Brazil: National Health Surveillance Agency (ANVISA) 407\u003c\/p\u003e \u003cp\u003e15.4.3.5 India: Central Drugs Standard Control Organization (CDSCO) 408\u003c\/p\u003e \u003cp\u003e15.4.3.6 China: National Medical Products Administration (NMPA) 409\u003c\/p\u003e \u003cp\u003e15.4.4 Challenges and Barriers to Clinical Research in Pregnant Persons 409\u003c\/p\u003e \u003cp\u003e15.5 Geriatric Populations 410\u003c\/p\u003e \u003cp\u003e15.5.1 Key Regulatory Guidelines Governing Geriatric Clinical Research 411\u003c\/p\u003e \u003cp\u003e15.5.2 Regional Legislations Governing Clinical Research in Geriatric Populations 412\u003c\/p\u003e \u003cp\u003e15.5.2.1 The United States: Food and Drug Regulatory Authority (us Fda) 412\u003c\/p\u003e \u003cp\u003e15.5.2.2 Europe: European Medicines Agency (EMA) 414\u003c\/p\u003e \u003cp\u003e15.5.2.3 The United Kingdom: The Medicines and Healthcare Products Regulatory Agency (MHRA) 415\u003c\/p\u003e \u003cp\u003e15.5.2.4 India: Central Drugs Standard Control Organization (CDSCO) 416\u003c\/p\u003e \u003cp\u003e15.5.2.5 Other Global Jurisdictions 417\u003c\/p\u003e \u003cp\u003e15.5.3 Challenges and Barriers to Clinical Research in Geriatric Populations 417\u003c\/p\u003e \u003cp\u003e15.6 Critical Care 417\u003c\/p\u003e \u003cp\u003e15.6.1 Key Regulatory Guidelines Governing Critical Care Clinical Research 418\u003c\/p\u003e \u003cp\u003e15.6.2 Regional Legislations Governing Clinical Research in Critical Care Populations 418\u003c\/p\u003e \u003cp\u003e15.6.2.1 The United States: Food and Drug Regulatory Authority (us Fda) 418\u003c\/p\u003e \u003cp\u003e15.6.2.2 Europe: European Medicines Agency (EMA) 420\u003c\/p\u003e \u003cp\u003e15.6.2.3 The United Kingdom: The Medicines and Healthcare Products Regulatory Agency (MHRA) 420\u003c\/p\u003e \u003cp\u003e15.6.2.4 India: Central Drugs Standard Control Organization (CDSCO) 421\u003c\/p\u003e \u003cp\u003e15.6.2.5 Other Global Jurisdictions 421\u003c\/p\u003e \u003cp\u003e15.6.3 Challenges and Barriers to Clinical Research in Critical Care Populations 422\u003c\/p\u003e \u003cp\u003e15.7 Summary Points 422\u003c\/p\u003e \u003cp\u003e15.7.1 Regulatory Guidelines 422\u003c\/p\u003e \u003cp\u003e15.7.2 Ethical Considerations 423\u003c\/p\u003e \u003cp\u003e15.7.3 Participant Recruitment 423\u003c\/p\u003e \u003cp\u003e15.8 Conclusion 423\u003c\/p\u003e \u003cp\u003eReferences 424\u003c\/p\u003e \u003cp\u003eIndex 435\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eSeth Kwabena Amponsah, PhD,\u003c\/b\u003e is an Associate Professor at the Department of Medical Pharmacology at the University of Ghana Medical School. He has published over 70 research articles, 20 book chapters, 4 books, and several conference abstracts. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eYashwant V. Pathak, PhD,\u003c\/b\u003e is Associate Dean for Faculty Affairs and Tenured Professor of Pharmaceutical Sciences at the University of South Florida. He has published over 410 research articles, reviews, book chapters, and books.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eAn up-to-date exploration of techniques for effectively treating patients from special populations\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eIn \u003ci\u003eBasics and Clinical Applications of Drug Disposition in Special Populations,\u003c\/i\u003e a team of distinguished researchers delivers a timely and authoritative discussion of how to predict drug disposition in special populations, including people with obesity, pediatric patients, geriatric patients, and patients with renal and hepatic impairment. The authors use pharmacokinetic models to account for variabilities between populations and to better predict drug disposition. \u003c\/p\u003e\u003cp\u003eThe book offers a collection of 15 chapters written by recognized experts in their respective fields. They cover topics ranging from the optimization of drug dosing regimens in specialized populations to model-based approaches in drug treatment among pediatrics. \u003c\/p\u003e\u003cp\u003eReaders will also find: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA thorough introduction to considerations and regulatory affairs for clinical research in special populations\u003c\/li\u003e\n\u003cli\u003eComprehensive explorations of drug disposition in geriatrics, patients with hepatic insufficiency, and patients with renal insufficiency \u003c\/li\u003e\n\u003cli\u003ePractical discussions of model-based pharmacokinetic approaches\u003c\/li\u003e\n\u003cli\u003eComplete treatments of artificial intelligence in drug development\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for practicing pharmacologists, pharmacists, and clinical chemists, \u003ci\u003eBasics and Clinical Applications of Drug Disposition in Special Populations \u003c\/i\u003ewill also benefit medical professionals who provide medical and pharmaceutical care to special populations.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988791640293,"sku":"NP9781394251285","price":225.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781394251285.jpg?v=1761781608","url":"https:\/\/k12savings.com\/products\/basics-and-clinical-applications-of-drug-disposition-in-special-populations-isbn-9781394251285","provider":"K12savings","version":"1.0","type":"link"}