Molecular Biopharmaceutics 1st Edition by Bente Steffansen ,Birger Brodin ,Carsten Uhd Nielsen – Ebook PDF Instant Download/Delivery:0853697221 ,978-0853697220
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Product details:
ISBN 10:0853697221
ISBN 13:978-0853697220
Author:Bente Steffansen ,Birger Brodin ,Carsten Uhd Nielsen
This is an introductory textbook on molecular biopharmaceutics. “Molecular Biopharmaceutics” involves the study of drug absorption, transport and delivery at the molecular level. In particular, increasing knowledge of the molecular structure and function of membrane transporter proteins and the understanding that they play a significant role in drug transport across biological membranes has lead to growing interest in this area from the pharmaceutical industry. This emerging knowledge of membrane transporter proteins has implications for understanding drug disposition and in turn for the development of more effective drug delivery strategies. The text provides an overview of the field of molecular biopharmaceutics, and explains its importance in drug development. It focuses on describing the interplay between the chemistry of drug molecules and membrane transporters, and will guide researchers in setting up experiments that may help in understanding the mechanisms and kinetics involved in drug absorption, transport and delivery.
Table of contents:
Outline
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Biopharmaceutics
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Pharmacokinetics
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Pharmacodynamics
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Toxicokinetics
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Measurement of drug concentration in biological matrices
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PK models
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Conclusion
List of abbreviations
References
Pharmacokinetics and biopharmaceutics: “a leader or attendant”
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Introduction
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The how’s and whys of pharmacokinetics
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Drug metabolism and toxicity
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Therapeutic response of drug
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The role of PK in the treatment of illnesses
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Cell-based model and in silico support to justify animal studies
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PK-coupled therapeutic drug monitoring
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Personalized therapy
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Patient counseling to follow administration protocol
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Awareness program toward food–drug interaction
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Conclusion
List of abbreviations
References
Dose, dosage regimen, and dose adjustment in organ failure
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Disease, drug, and dose of drug
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Dosing individualization
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Dosage regimen
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Organ failure
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What is dose adjustment in organ failure?
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Dose adjustment in renal failure
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Dose adjustment in hepatic failure
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Individual dose adjustment of riociguat in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
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Dose adjustment of anesthetics in the morbidly obese
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Platelet testing to guide aspirin dose adjustment in pediatric patients after cardiac surgery
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Multiple organ dysfunction syndromes
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Patterns and early evolution of organ failure in the intensive care unit and their relation to the outcome
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Conclusion
List of abbreviations
References
Pharmacokinetics aspects of structural modifications in drug design and therapy
Abstract
Outline
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Introduction
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Structural requirements and ideal properties of classes of drugs
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Molecular modifications affecting ADME properties of drugs
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Molecular modifications affecting physicochemical properties of drugs
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Prodrug approach to enhance PK of drugs
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Effect of isomers of drugs on its PK
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Conclusion
List of abbreviations
References
Biopharmaceutical considerations in the pediatric and geriatric formulation development
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Introduction
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Hurdles in fabrications of age-appropriate products
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Characteristic of an ideal formulation for special age-group
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Type of formulations and route of delivery
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Design of flexible formulations for pediatrics and geriatrics
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Current status of the research and marketed oral products for specific age-group population
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Global regulations for pediatric and geriatrics
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Pharmacokinetics or clinical reports on pediatric product development
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Pharmacokinetics or clinical report on the geriatric population
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Conclusion
List of abbreviations
References
Kinetics of maternal–fetal drug transfer
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Introduction and general principle
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Factors affecting maternal–fetal drug transfer
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Kinetics of maternal–fetal drug transfer
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Model to assess placental drug transport
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Conclusion
List of abbreviations
References
Chronopharmacokinetics
Introduction
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Things to know “chronotherapeutics”
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Biological rhythm involved in cPK
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Influence of circadian rhythms on the PK of the drugs
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Factors that affect the PK of the drug: a quick overview
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Applications of cPK
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Recently available different technologies for chronotherapy
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Hurdles in chronopharmaceutical drug research and development
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Conclusion
List of abbreviations
References
Pharmacokinetic characterization of drugs and new product development
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Introduction
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The rationale of PK studies in different phases of drug development
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Pharmacokinetic concepts and parameters (theory and rationale)
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Prediction of PK parameters in the early (preclinical) stage of drug development
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PK characterization (studies) in the clinical stage of drug development
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Application of PKPD modeling in drug development
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Microdosing PK studies in drug development (phase 0)
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Micro-pharmacokinetics in drug discovery and product development
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Case study on “Pharmacokinetic characterization of the clinical phase of development of dupilumab, a blockbuster in atopic dermatitis”
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Conclusion
List of abbreviations
References
Pharmacokinetics modeling in drug delivery
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Pharmacokinetics parameters
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Pharmacogenetic factors influencing PK of the drug
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PK models
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PK modeling in pediatrics drug development
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Conclusion
List of abbreviations
References
Drug metabolic kinetics
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Introduction
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Metabolic kinetics of uncatalyzed reaction
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Reaction orders
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MK of reactions involving enzyme (E) catalysis
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Conclusion
List of abbreviations
References
Pharmacogenomics and drug metabolism
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Introduction
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The influence of pharmacogenomics on PK and PD
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Effect of genetic variation on PK processes
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Effect of genetic variability on PD and dosing regimen design
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Genetic variation in CYP enzyme metabolism
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Clinical applications of CYP polymorphisms
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Polymorphism in enzymes
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Polymorphisms in drug transporter genes
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AmpliChip CYP450 test
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Methods to conduct pharmacogenomics studies
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Conclusion
List of abbreviations
References
Revamping the pharmacokinetics of poorly soluble drugs using different formulations
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Introduction
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Old drugs in a new form to enhance the pharmacokinetics of poorly water soluble drugs
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Future prospective
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Conclusion
List of abbreviations
References
Molecular mechanisms of circadian rhythm and its influence on the pharmacokinetics of drugs
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The molecular circadian clock and its regulation
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Functions of the molecular clock
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Influence of physical movement on circadian rhythms
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Metabolic regulation of circadian rhythms
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The role of synchronizers in circadian rhythm
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Monitoring of circadian rhythm and detecting techniques
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Influence of circadian rhythms on the pharmacokinetics of the drug
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Conclusion
List of abbreviations
References
Influence of fever on pharmacokinetics of drugs
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Introduction
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Effect of fever on physiological changes and their influence on the PK profile of drugs
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Effect of fever on the PK of some drug classes
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Conclusion
List of abbreviations
References
Implications for sex-related issues in clinical pharmacology and biopharmaceutics
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Introduction
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Historical review
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Where men and women differ—a view of health professionals
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Sex-based clinical pharmacology and PD
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Adverse drug reactions in women
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Sex-based biopharmaceutics and PK
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Potential risk to women childbearing capacity
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Medications used in pregnancy
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Sex-by-formulation interactions
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Policy and regulations—the new era
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Conclusion
List of abbreviations
References
Further reading
Bioanalytical method development and validation for establishing bioavailability and bioequivalence
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Introduction
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Study design and procedures to conduct BA study
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Technological developments over time in bioanalytical method development
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The terminology used in bioanalytical method validation (BMV)
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BMV parameters
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Sample extracting techniques
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Trends in bioanalytical method development and validation
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Future prospectives
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Conclusion
List of abbreviations
References
Factors affecting the stability of drugs and their metabolites in biological matrices
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Introduction
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Sources of drug instability in biological matrices
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Factors affecting the drug stability in the biological matrix
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Regulatory recommended stability studies for bioanalysis
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Strategies to overcome the stability problems of drugs and their metabolites in biological matrices
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Conclusion
List of abbreviations
References
Pharmacokinetics aspects of biotechnological products
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Introduction to biotechnological products
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Pitfalls in PK and or pharmacodynamics of biotechnological products
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PK of protein and peptide drugs
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PK of RNAi
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PK of MAbs
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Bioequivalence of biotechnological products
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Preclinical and clinical development of MAbs, RNAi, peptide, and protein drugs
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Regulatory guidance
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Future prospects
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Conclusion
List of abbreviations
References
Factors affecting the pharmacokinetics of the liposomal drugs
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Introduction
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Mechanisms of liposomal absorption through oral route
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Factors affecting the pharmacokinetics of the liposomes
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Conclusion
List of abbreviations
References
Microdialysis: an emerging technique for pharmacokinetic–pharmacodynamic profiling
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Introduction
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Features of PK–PD modeling
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The principle of MD for PK–PD studies
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Experimental setup of MD in rats
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Preclinical and clinical application of MD for PK–PD studies
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Conclusion
List of abbreviations
References
Positron emission tomography as a noninvasive tool in pharmacokinetic studies
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Introduction
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Principle of PET
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Instrumentation of PET
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Radiolabeling for PET
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FDA-approved process for PET probe
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Routes of administration in PET-based PK study
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PET microdosing
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PK of drugs with PET
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Static PET acquisition
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Dynamic PET acquisition
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Role of PET for biodistribution and PK study of theranostic agents
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Limitations of PET
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Conclusion
List of abbreviations
References
“Organ-on-a-chip”-based physiologically relevant pharmacokinetic models
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Introduction: organ-on-a-chip
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Understanding OOAC
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Key components of OOAC
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Role of OOAC in physiologically based PK model
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In vitro PK/PD modeling with vascularized organ chips
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Determination of PK parameters using the first-pass vascularized organ chip system
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Emerging OOAC technologies
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In vitro–in vivo extrapolation
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Fluidically coupled vascularized organ chips as a tool to quantitatively predict human PK responses
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Conclusion
List of abbreviations
References
Artificial intelligence in preventive and managed healthcare
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Introduction
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Need for AI implementation
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AI in healthcare and medicine
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Conclusion
List of abbreviations
References
Software used in ADME computation
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Introduction
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Computational PK in drug discovery
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Computational software in personalized medicine
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Conclusion
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Tags: Bente Steffansen, Birger Brodin, Carsten Uhd Nielsen, Molecular, Biopharmaceutics


