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Intro -- Foreword -- Preface -- Contents -- About the Editors -- Contributors -- 1: Therapeutic and Toxic Concentrations of Drugs in Biological Matrices -- 1.1 Introduction -- 1.2 Therapeutic Drug Monitoring -- 1.3 Biological Matrices -- 1.3.1 Blood -- 1.3.2 Urine -- 1.3.3 Saliva -- 1.3.4 Cerebrospinal Fluid (CSF) -- 1.3.5 Hair -- 1.4 Therapeutic Concentration of Drugs -- 1.5 Toxic Concentration of Drugs -- 1.6 Conclusion -- References -- 2: Analytical Techniques for Therapeutic Drug Monitoring and Clinical Toxicology -- 2.1 Introduction -- 2.2 Immunoassays -- 2.3 Electrophoresis -- 2.4 Biosensors -- 2.5 Conventional HPLC and Emerging UHPLC Techniques -- 2.6 Gas Chromatography (GC) -- 2.7 Conclusion and Outlook -- References -- 3: Plasma Therapeutic Drug Monitoring and Clinical Toxicology -- 3.1 Overview of Therapeutic Drug Monitoring (TDM) -- 3.1.1 Assumptions -- 3.1.2 Process of Therapeutic Drug Monitoring -- 3.2 Indications for Measuring Plasma Concentrations -- 3.2.1 Avoiding or Diagnosing Toxicity -- 3.2.2 Diagnosing Undertreatment and Monitoring Patient Adherence -- 3.2.3 Prophylaxis -- 3.2.4 Drug Interactions and Termination of Treatment -- 3.3 Proper Use of Measurements -- 3.3.1 Timing of Blood Samples -- 3.3.2 Type of Sample Used -- 3.3.3 Measurement Technique -- 3.3.4 Individualization of Results -- 3.4 Individualizing Therapy -- 3.4.1 Formulation and Diet -- 3.4.2 Pharmacokinetics: Ion Trapping -- 3.4.3 Pathologic Disease States -- 3.4.4 Cytochrome P450 Enzymes -- 3.4.5 Age -- 3.5 Serum Versus Plasma Monitoring -- 3.5.1 Drugs Requiring Monitoring: Digoxin -- 3.5.2 Drugs Requiring Monitoring: Phenytoin -- 3.6 Renal Clearance and Metabolism in Therapeutic Drug Monitoring -- 3.6.1 Critically Ill Patients -- 3.6.2 Geriatric Patients -- 3.6.3 Pediatric Patients.
3.6.4 Acute or Chronic Renal Failure Patients -- 3.7 Role of Cytochrome P450 Systems in Liver Clearance and Metabolism -- 3.7.1 Acetaminophen -- 3.7.2 Rifampin -- 3.7.3 Erythromycin -- 3.8 Antiretrovirals and Glucose in Therapeutic Drug Monitoring -- 3.8.1 The Role and Influence of Glucose in Therapeutic Drug Monitoring -- 3.8.2 Therapeutic Drug Monitoring of Antiretroviral Drugs -- 3.9 Conclusion -- References -- 4: Dried Blood Spots in Therapeutic Drug Monitoring and Toxicology -- 4.1 Introduction -- 4.2 Therapeutic Drug Monitoring (TDM) -- 4.2.1 DBS in PK Monitoring -- 4.2.2 Factors to Consider in PK Studies Using DBS Sampling -- 4.2.3 Toxicology -- 4.2.3.1 Toxicokinetics -- 4.2.3.2 Forensic Toxicology -- 4.2.3.3 Screening for Environmental Contaminants -- 4.3 The Hematocrit Factor -- 4.3.1 Holistic Analysis of Volumetrically Spotted DBS -- 4.3.2 Use of DPS in Place of DBS -- 4.3.3 Use of Special Filter Substrates -- 4.3.4 Use of Hematocrit Calibrators -- 4.3.5 Estimation or Prediction of Hematocrit -- 4.4 General Steps in DBS Sampling -- 4.4.1 Selection of Filter Material -- 4.4.2 Collection of Specimen -- 4.4.3 Drying of Spotted Cards -- 4.4.4 Packaging of DBS for Storage and Transport -- 4.4.5 Extraction and Analysis of Analyte -- 4.4.6 Validation of DBS-Based Analytical Processes -- 4.5 Recent Innovative DBS Sampling Alternatives -- 4.6 High-Throughput Application of DBS Sampling -- 4.7 Conclusion and Future Perspectives -- References -- 5: The Role of Artificial Intelligence in Therapeutic Drug Monitoring and Clinical Toxicity -- 5.1 Introduction -- 5.2 AI Terms -- 5.2.1 Machine Learning (ML) -- 5.2.2 Deep Learning (DL) -- 5.2.3 Artificial Neural Network (ANN) -- 5.3 Implementing AI in Drug Design: Early Stages -- 5.4 Essentials for Implementing AI in Drug Discovery -- 5.4.1 Data Describing the System.
5.4.2 Integration of Data -- 5.4.3 System Stability -- 5.4.4 Dimension and Interdependency -- 5.4.5 Field Knowledge -- 5.5 AI or Ligand Discovery: Which One Is Critical in Drug Discovery? -- 5.6 AI in Drug Monitoring: Gathering Medical Big Data -- 5.7 Pipeline for Disease Monitoring -- 5.7.1 Target Selection, Validation -- 5.7.2 Design, Optimization of Drug Design -- 5.7.3 Clinical Studies (Virtual) -- 5.8 AI in Pharmacovigilance -- 5.9 AI in Toxicity -- 5.10 Structural Toxicity for Endpoints -- 5.10.1 Toxicity for Multiple-Time Point Assays -- 5.11 AI for Drug Safety: Recent Advances and Post-Market Surveillance -- 5.12 Illusions and Reality of AI in Drug Design -- 5.13 Future of AI in Drug Design -- 5.14 Conclusions -- References -- 6: Therapeutic Drug Monitoring and Optimal Pharmacotherapy with Medicines of Narrow Therapeutic Index -- 6.1 Background -- 6.2 Therapeutic Drug Monitoring -- 6.3 Medicines That Are Known to Require Therapeutic Drug Monitoring -- 6.4 Medication Therapy That Requires TDM for Optimal Outcomes -- 6.5 Guidelines for Sample Collection -- 6.6 Timing of Plasma Sample for TDM -- 6.7 Request for Therapeutic Drug Monitoring -- 6.8 Therapeutic Drug Monitoring and Interpretation of Results -- 6.9 Medications That May Benefit from Therapeutic Drug Monitoring -- 6.10 Techniques for Measurement of Therapeutic Drug Monitoring -- 6.11 Practical Use of Therapeutic Drug Monitoring -- References -- 7: Therapeutic Drug Monitoring (TDM) and Toxicological Studies in Alternative Biological Matrices -- 7.1 Introduction -- 7.2 Therapeutic Drug Monitoring (TDM) -- 7.2.1 Purpose of Therapeutic Drug Monitoring (TDM) -- 7.2.2 TDM: Estimating Plasma Drug Concentration -- 7.2.3 TDM Analytical Issues -- 7.2.4 Practical Issues in TDM -- 7.2.5 TDM's Translational Challenges -- 7.2.6 Recent Advances in TDM Practice.
7.2.6.1 Chromatographic Methods -- 7.2.6.2 Immunoassays -- 7.2.6.3 Biosensors -- 7.2.6.4 Biochips -- 7.3 Science of Toxicology -- 7.3.1 Toxicology: Biological Sampling and Use of Different Analytical Techniques -- 7.3.1.1 Reasons for Testing -- 7.3.1.2 Pharmacologic Reasons -- 7.3.1.3 Pharmacokinetic Reasons -- 7.3.1.4 Availability of Specimens -- 7.3.1.5 Ease of Collection -- 7.4 Alternative Matrices in Toxicology -- 7.5 Different Approaches in Various Biological Matrices, with an Emphasis on Toxicology -- 7.5.1 Microextraction Techniques in Different Biological Matrices -- 7.5.2 Other Green Extraction Technique Application -- 7.5.3 Applications of Mass Spectrometry Techniques in Alternative Biological Matrices -- 7.6 Artificial Intelligence (AI) in Toxicity and Drug Discovery -- 7.7 Promises and Pitfalls of Alternative Matrices -- 7.8 Artificial Intelligence (AI) in Toxicology and TDM -- 7.8.1 Artificial Intelligence for Clinical Toxicity and Patient Safety -- 7.8.2 Artificial Intelligence (AI) in the Prediction of Adverse Drug Reaction (ADR) and a Case Study -- 7.9 Importance and Future Perspective of TDM -- 7.10 Challenges Faced in Managing Patient Health Data -- 7.11 Conclusions -- References -- 8: Analyzing Data from Therapeutic Drug Monitoring, Pharmacokinetics, and Clinical Toxicology Studies -- 8.1 Introduction -- 8.1.1 Software Setup -- 8.2 Endpoints -- 8.3 Types of Data -- 8.4 Data Handling -- 8.5 Pharmacokinetics -- 8.5.1 Single-Dose PK Parameters -- 8.5.1.1 Cmax and tmax -- 8.5.1.2 AUCt -- 8.5.1.3 λ and t1/2 -- 8.5.1.4 AUC∞ -- 8.5.1.5 CL/F and Vd/F -- 8.5.2 Steady-State PK Parameters -- 8.5.2.1 Cav,SS and CSS -- 8.5.2.2 Ctrough and Cmax,SS -- 8.6 Pharmacodynamics -- 8.6.1 PK/PD -- 8.7 Descriptive and Inferential Statistics -- 8.7.1 Statistical Hypothesis Testing -- 8.7.1.1 Type I Error.
8.7.1.2 Type II Error -- 8.7.1.3 Significance Testing and p-Value -- 8.7.2 Confidence Interval (CI) -- 8.8 Sample Size and Power -- 8.9 Analysis Methods -- 8.9.1 Categorical Endpoints/Comparison of Proportions -- 8.9.1.1 Chi-Square Test -- 8.9.1.2 Fisher's Exact Test -- 8.9.1.3 McNemar Test -- 8.9.1.4 Logistic Regression -- 8.9.2 Continuous Endpoints/Comparison of Means -- 8.9.2.1 One-Sample T-Test -- 8.9.2.2 One-Sample Wilcoxon Test -- 8.9.2.3 Independent T-Test -- 8.9.2.4 Wilcoxon Rank Sum (Mann-Whitney U) Test -- 8.9.2.5 Paired T-Test -- 8.9.2.6 Wilcoxon Signed Rank Test -- 8.9.2.7 Linear Regression -- 8.9.2.8 Analysis of Variance (ANOVA) -- 8.9.2.9 Kruskal-Wallis Test -- References -- 9: Reducing Toxicity in Critically Ill Patients by Using Therapeutic Drug Monitoring -- 9.1 Introduction -- 9.1.1 Critically Ill Patients -- 9.1.2 Therapeutic Drug Monitoring -- 9.2 Antimicrobial Agents -- 9.2.1 General Pharmacokinetics (PK)/Pharmacodynamics (PD) Targets -- 9.2.2 Antibacterial Agents/Antibiotics -- 9.2.2.1 Aminoglycosides -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.2.2 ß-Lactams -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.2.3 Fluoroquinolones -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.2.4 Vancomycin -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.2.5 Linezolid -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.3 Antifungal Agents -- 9.2.3.1 Fluconazole -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.3.2 Flucytosine -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.4 Antiviral Agents -- 9.2.4.1 Acyclovir/Valacyclovir -- PK/PD Targets -- Dose Adjustment Strategies -- Bioanalytical Assay -- 9.2.4.2 Ribavirin.
PK/PD Targets.
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Ain Shams Journal of Forensic Medicine and Clinical Toxicology
