Basics and Clinical Applications of Drug Disposition in Special Populations

• Autore: Amponsah Seth Kwabena
• Pubblicazione: Newark : , : John Wiley & Sons, Incorporated, , 2025; ©2025
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (483 pages)
• Disciplina: 615.7
• Soggetto topico: Pharmaceutical Preparations - metabolism; Pharmaceutical Preparations - administration & dosage; Pharmacokinetics; Drug Monitoring - methods; Drug Therapy - methods
• Altri autori: PathakYashwant
• Nota di contenuto: Cover -- Title Page -- Copyright Page -- Dedication -- Contents -- About the Editors -- List of Contributors -- Foreword -- Preface -- Chapter 1 Pharmacokinetic Principles and Concepts: An Overview -- 1.1 Introduction -- 1.2 Pharmacokinetic Parameters -- 1.2.1 Absorption -- 1.2.2 Distribution -- 1.2.3 Metabolism -- 1.2.4 Excretion -- 1.3 Pharmacokinetic Models -- 1.4 Applications -- 1.5 Conclusion -- References -- Chapter 2 Model-Based Pharmacokinetic Approaches -- 2.1 Introduction -- 2.1.1 Importance of PK -- 2.1.2 Overview of Model-Based Approaches -- 2.2 Basics of Pharmacokinetics -- 2.2.1 Key Pharmacokinetic Parameters -- 2.2.1.1 Absorption -- 2.2.1.2 Key Parameter -- 2.2.1.3 Distribution -- 2.2.1.4 Key Parameter -- 2.2.1.5 Metabolism -- 2.2.1.6 Key Parameter -- 2.2.1.7 Excretion -- 2.2.1.8 Key Parameter -- 2.2.2 Differences Between Traditional and Model-Based Pharmacokinetic Approaches -- 2.3 Pharmacokinetic (PK) Models -- 2.3.1 Introduction -- 2.3.2 Compartment Modeling -- 2.3.2.1 One-CompartmentModel -- 2.3.2.2 Multi-CompartmentModel -- 2.3.2.3 Two-CompartmentModel -- 2.3.3 Population PK Model -- 2.3.4 Physiologically Based PK (PBPK) Model -- 2.4 Model Development and Validation -- 2.4.1 Data Requirements for Model Development -- 2.4.2 Data Requirements for Model Validation -- 2.4.3 Steps in Model Building (E.g., Model Selection and Parameter Estimation) -- 2.5 Applications of Model-Based Approaches -- 2.5.1 Dose Optimization -- 2.5.2 Predicting Drug Interactions -- 2.5.3 Drug Tailoring in Special Populations (E.g., Pediatrics, Geriatrics, and Renal Impairment) -- 2.5.4 Translational PK from Preclinical to Clinical Settings -- 2.6 Modeling in Special Populations -- 2.6.1 Challenges and Considerations -- 2.6.1.1 Challenges in PK Modeling -- 2.6.1.2 Considerations in PK Modeling -- 2.7 Software and Tools for PK Modeling -- 2.7.1 Gastroplus™. ; 2.7.2 Berkeley Madonna -- 2.7.3 MATLAB -- 2.7.4 PK-Sim® -- 2.7.5 Simcyp® -- 2.7.6 Auxiliary PBPK Modeling Software -- 2.7.6.1 Julia -- 2.7.6.2 NONMEM -- 2.7.6.3 Phoenix WinNonlin -- 2.7.6.4 GraphPad Prism -- 2.7.6.5 Minitab -- 2.7.6.6 PlotDigitizer -- 2.7.6.7 GNU MCSim -- 2.7.6.8 WebPlotDigitizer -- 2.8 Regulatory Perspectives of PK Modeling -- 2.9 Future Directions of PK Modeling -- 2.10 Conclusion -- Abbreviations -- References -- Chapter 3 Physiologically Based Pharmacokinetic Modeling -- 3.1 Introduction -- 3.2 Significance of PBPK Modeling -- 3.3 Principles for the Development of PBPK for Special Populations -- 3.4 Data Integration for Special Populations -- 3.4.1 Demographic Data -- 3.4.2 Physiological Consideration -- 3.4.3 Ontogeny -- 3.4.4 Age and Maturation Changes -- 3.4.5 Steady State Volume of Distribution (Vdss) -- 3.5 Applications of PBPK Modeling -- 3.5.1 Dose Optimization/Regimen/Selection -- 3.5.2 Dose Individualization/Precision Dosing -- 3.5.3 Biopharmaceutics -- 3.6 Regulatory Applications/Pre-Post Market Utilization -- 3.7 Case Studies -- 3.7.1 Simulation Application -- 3.7.2 Successful Applications -- 3.8 Lessons Learned -- 3.9 Conclusion -- References -- Chapter 4 Therapeutic Drug Monitoring in Special Populations -- 4.1 Introduction -- 4.2 Pediatrics -- 4.2.1 Importance of TDM in Pediatrics -- 4.2.2 Pharmacokinetic Differences in Pediatric Patients -- 4.2.3 Drug Absorption in the Pediatric Population -- 4.2.4 Drug Distribution in the Pediatric Population -- 4.2.5 Drug Metabolism and Elimination in the Pediatric Population -- 4.3 TDM Practices in Pediatrics -- 4.3.1 Vancomycin -- 4.3.2 Aminoglycosides -- 4.3.3 Ganciclovir/Valganciclovir -- 4.3.4 Antiepileptic Drugs (AEDs) -- 4.3.5 Enoxaparin -- 4.4 Conclusion -- 4.5 Pregnancy -- 4.5.1 Physiological Adaptations in Pregnancy. ; 4.5.2 Current State of Clinical Practice of TDM in Pregnancy -- 4.5.3 TDM in Pregnancy -- 4.5.3.1 Antiepileptics -- 4.5.3.2 Antidepressants -- 4.5.3.3 Antiretroviral Drugs -- 4.5.3.4 Immunomodulatory Drugs -- 4.5.4 Challenges in the Implementation of TDM in the Pregnant Population -- 4.6 The Elderly -- 4.6.1 Physiological Changes in the Elderly -- 4.6.2 Effect of Aging on Drug Pharmacokinetics -- 4.6.3 Application of TDM in the Elderly -- 4.6.3.1 Cardiac Glycosides -- 4.6.3.2 Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) -- 4.6.3.3 Anticoagulants -- 4.6.3.4 Benzodiazepines -- 4.7 Conclusion -- 4.8 Hepatic and Renal Impairments -- 4.8.1 Hepatic Impairment -- 4.8.2 TDM in Patients with Hepatic Impairment -- 4.8.2.1 Meropenem -- 4.8.2.2 Metoprolol -- 4.8.2.3 Midazolam -- 4.8.3 Renal Impairment -- 4.8.4 Prerenal Disease -- 4.8.5 Intrinsic Renal Vascular Disease -- 4.8.6 Intrinsic Glomerular Disease (Nephritic or Nephrotic) -- 4.8.7 TDM in Renal Impairment -- 4.8.7.1 Vancomycin -- 4.8.7.2 Metformin -- 4.9 Conclusion -- 4.10 Overall Conclusion and Future Direction -- Acknowledgment -- References -- Chapter 5 Optimization of Drug Dosing Regimen -- 5.1 Introduction -- 5.2 Dosing Regimen Optimization Approaches and Strategies -- 5.2.1 Models Used for Dosing Regimen Selection -- 5.2.1.1 Pharmacometric Models -- 5.2.1.2 PK Models -- 5.2.1.3 Empirical Dose-Response Models -- 5.2.1.4 Multiple Comparison Procedures Models (MCP-Mod) -- 5.2.1.5 Model Averaging -- 5.2.2 Role of Patient Characteristics in Dose Selection -- 5.2.2.1 Phenotype-GuidedDosing -- 5.2.2.2 Genotype-GuidedDrug Dosing -- 5.2.3 Therapeutic Drug Monitoring (TDM) -- 5.3 Dosing Regimen in Special Populations -- 5.3.1 Dosing Regimen in Cancer Patients -- 5.3.1.1 Metronomic Chemotherapy -- 5.3.2 Dosing Regimen for Patients on Antimicrobial Therapy -- 5.3.2.1 Antimicrobial Stewardship Strategy. ; 5.3.2.2 Mathematical Models for Optimizing Antimicrobial Therapy -- 5.3.2.3 Antimicrobial Dosing Strategies During CRRT -- 5.3.2.4 Methods for Enhancing Dosing of Antimicrobials via Nebulization -- 5.3.3 Dosing Regimen in Pediatric Patients -- 5.3.3.1 Physiological Differences Between Pediatric and Adult Patients -- 5.3.3.2 Application of MIDD in Pediatric Dose Selection -- 5.3.3.3 Scaling from Adults to Pediatric Patients -- 5.3.3.4 Scaling from Animals to Pediatric Patients -- 5.3.3.5 Integrating Mechanistic Models in Neonates and Infants -- 5.3.3.6 Dose Optimization in Neonates and Infants -- 5.4 Conclusion -- References -- Chapter 6 Artificial Intelligence in Drug Development -- 6.1 Introduction -- 6.2 Application of AI in Drug Design -- 6.2.1 Target Identification and Validation -- 6.2.2 Drug Candidate Design and Optimization -- 6.2.3 Virtual Screening and Molecular Docking -- 6.2.4 Synthesis Planning -- 6.2.5 Predicting Drug Toxicity and Pharmacokinetics -- 6.2.6 Personalized Medicine -- 6.3 AI Use in Drug Formulation -- 6.4 Drug Release Characterization Using AI -- 6.5 AI-Based Dose/Dosing Regimen -- 6.6 Dissolution Rate Predictions with AI -- 6.7 Clinical End-Point Evaluation with AI -- 6.8 AI in Prediction of Fate of Drugs Administered Via Mucosal, Transdermal, and Parenteral Routes -- 6.9 AI-Integrated Mechanistic Modeling Platform for Drug Delivery and Monitoring -- 6.10 AI-Based Tools for Metabolism and Clearance Prediction -- 6.11 Limitations of Existing Tools -- 6.12 Conclusions -- 6.13 Conflict of Interest -- Acknowledgments -- References -- Chapter 7 Drug Disposition in Neonates and Infants -- 7.1 Introduction -- 7.2 Drug Absorption in Neonates and Infants -- 7.3 Drug Distribution in Neonates and Infants -- 7.4 Hepatic Metabolism of Drugs in Neonates and Infants -- 7.4.1 Phase I Metabolism -- 7.4.2 Phase II Metabolism. ; 7.5 Drug Excretion in Neonates and Infants -- 7.6 Pharmacodynamics in Neonates and Infants -- 7.7 Age-Related Dosing Regimen in Neonates and Infants -- 7.8 Conclusion -- References -- Chapter 8 Drug Disposition in Adolescents -- 8.1 Introduction -- 8.2 Physiological Considerations in Adolescents -- 8.2.1 Organ Development: Liver and Kidney Maturation -- 8.2.2 Variations in Body Composition -- 8.2.3 Hormonal Changes -- 8.2.3.1 Males -- 8.2.3.2 Females -- 8.2.4 Other Physiological Changes -- 8.3 Medication Adherence Challenges in Adolescents -- 8.4 Psychological Development on Drug Disposition -- 8.5 Risk-Taking behaviors and Their Implications on Medication Use -- 8.6 Drug Use Among Adolescents -- 8.6.1 Acetaminophen Use in Adolescents -- 8.6.2 Antidepressant Use in Adolescents -- 8.6.3 Drugs for ADHD -- 8.7 Pharmacokinetic Variability in Adolescents Drug Examples -- 8.7.1 Acetaminophen -- 8.7.2 Theophylline -- 8.7.3 Antidepressants -- 8.7.4 Drugs for ADHD -- 8.8 Legal and Ethical Considerations -- 8.8.1 Consent and Confidentiality in Adolescent Healthcare -- 8.8.2 Involving Adolescents in Treatment Decisions -- 8.8.3 Regulatory Aspects of Adolescents Drug Prescribing -- 8.9 Conclusion -- References -- Chapter 9 Drug Disposition in Pregnancy -- 9.1 Introduction -- 9.2 Physiological Changes in Pregnancy -- 9.2.1 Changes in Absorption -- 9.2.2 Changes in Distribution and Free Medication -- 9.2.3 Changes in Cytochrome Metabolism -- 9.2.4 Changes in Renal Excretion -- 9.2.5 General Considerations in Drug Dosing with Pregnancy -- 9.3 Placental Drug Disposition -- 9.3.1 Placental Barrier Anatomy and Physiology -- 9.3.2 Placental Transport Mechanisms -- 9.3.3 Methods of Study for Placental Drug Transfer -- 9.4 Drug Classification in Pregnancy -- 9.5 Pharmacokinetic (PK) Modeling -- 9.6 Physiologically Based Pharmacokinetic (PBPK) Modeling. ; 9.7 Limitations in PK and PBPK Models.
• Sommario/riassunto: "This book, in 15 chapters, presents fundamental facts alongside practical and clinically-related data. Contributors bring expert perspectives in the field of pharmacokinetics, pharmacodynamics, mathematical and computational science to the coverage. The topics include: optimization of drug dosing regimen in specialized populations, model-based approaches in drug treatment among pediatrics, pharmacotherapeutic considerations in pregnancy and lactation, and therapeutic drug monitoring in special populations. Pavadharini Ravindran [e-mail] 914443950500"--
• Titolo autorizzato: Basics and Clinical Applications of Drug Disposition in Special Populations
• ISBN: 9781394251292; 1394251297; 9781394251308; 1394251300; 9781394251315; 1394251319
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9911019742603321
• Lo trovi qui: Univ. Federico II