Biopharmaceutics and Pharmacokinetics Considerations

Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce.

Cover image
Title page
Table of Contents
Copyright
Dedication
List of contributors
Chapter 1. Overview of biopharmaceutics and pharmacokinetics
Abstract
Outline
1.1 Biopharmaceutics
1.2 Pharmacokinetics
1.3 Pharmacodynamics
1.4 Toxicokinetics
1.5 Measurement of drug concentration in biological matrices
1.6 PK models
1.7 Conclusion
List of abbreviations
References
Chapter 2. Pharmacokinetics and biopharmaceutics: “a leader or attendant”
Abstract
Outline
2.1 Introduction
2.2 The how’s and whys of pharmacokinetics
2.3 Drug metabolism and toxicity
2.4 Therapeutic response of drug
2.5 The role of PK in the treatment of illnesses
2.6 Cell-based model and in silico support to justify animal studies
2.7 PK-coupled therapeutic drug monitoring
2.8 Personalized therapy
2.9 Patient counseling to follow administration protocol
2.10 Awareness program toward food–drug interaction
2.11 Conclusion
List of abbreviations
References
Chapter 3. Dose, dosage regimen, and dose adjustment in organ failure
Abstract
Outline
3.1 Disease, drug, and dose of drug
3.2 Dosing individualization
3.3 Dosage regimen
3.4 Organ failure
3.5 What is dose adjustment in organ failure?
3.6 Dose adjustment in renal failure
3.7 Dose adjustment in hepatic failure
3.8 Individual dose adjustment of riociguat in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
3.9 Dose adjustment of anesthetics in the morbidly obese
3.10 Platelet testing to guide aspirin dose adjustment in pediatric patients after cardiac surgery
3.11 Multiple organ dysfunction syndromes
3.12 Patterns and early evolution of organ failure in the intensive care unit and their relation to the outcome
3.13 Conclusion
List of abbreviations
References
Chapter 4. Pharmacokinetics aspects of structural modifications in drug design and therapy
Abstract
Outline
4.1 Introduction
4.2 Structural requirements and ideal properties of classes of drugs
4.3 Molecular modifications affecting ADME properties of drugs
4.4 Molecular modifications affecting physicochemical properties of drugs
4.5 Prodrug approach to enhance PK of drugs
4.6 Effect of isomers of drugs on its PK
4.7 Conclusion
List of abbreviations
References
Chapter 5. Biopharmaceutical considerations in the pediatric and geriatric formulation development
Abstract
Outline
5.1 Introduction
5.2 Hurdles in fabrications of age-appropriate products
5.3 Characteristic of an ideal formulation for special age-group
5.4 Type of formulations and route of delivery
5.5 Design of flexible formulations for pediatrics and geriatrics
5.6 Current status of the research and marketed oral products for specific age-group population
5.7 Global regulations for pediatric and geriatrics
5.8 Pharmacokinetics or clinical reports on pediatric product development
5.9 Pharmacokinetics or clinical report on the geriatric population
5.10 Conclusion
List of abbreviations
References
Chapter 6. Kinetics of maternal–fetal drug transfer
Abstract
Outline
6.1 Introduction and general principle
6.2 Factors affecting maternal–fetal drug transfer
6.3 Kinetics of maternal–fetal drug transfer
6.4 Model to assess placental drug transport
6.5 Conclusion
List of abbreviations
References
Chapter 7. Chronopharmacokinetics
Abstract
Outline
7.1 Introduction
7.2 Things to know “chronotherapeutics”
7.3 Biological rhythm involved in cPK
7.4 Influence of circadian rhythms on the PK of the drugs
7.5 Factors that affect the PK of the drug: a quick overview
7.6 Applications of cPK
7.7 Recently available different technologies for chronotherapy
7.8 Hurdles in chronopharmaceutical drug research and development
7.9 Conclusion
List of abbreviations
References
Chapter 8. Pharmacokinetic characterization of drugs and new product development
Abstract
Outline
8.1 Introduction
8.2 The rationale of PK studies in different phases of drug development
8.3 Pharmacokinetic concepts and parameters (theory and rationale)
8.4 Prediction of PK parameters in the early (preclinical) stage of drug development
8.5 PK characterization (studies) in the clinical stage of drug development
8.6 Application of PKPD modeling in drug development
8.7 Microdosing PK studies in drug development (phase 0)
8.8 Micro-pharmacokinetics in drug discovery and product development
8.9 Case study on “Pharmacokinetic characterization of the clinical phase of development of dupilumab, a blockbuster in atopic dermatitis”
8.10 Conclusion
List of abbreviations
References
Chapter 9. Pharmacokinetics modeling in drug delivery
Abstract
Outline
9.1 Pharmacokinetics parameters
9.2 Pharmacogenetic factors influencing PK of the drug
9.3 PK models
9.4 PK modeling in pediatrics drug development
9.5 Conclusion
List of abbreviations
References
Chapter 10. Drug metabolic kinetics
Abstract
Outline
10.1 Introduction
10.2 Metabolic kinetics of uncatalyzed reaction
10.3 Reaction orders
10.4 MK of reactions involving enzyme (E) catalysis
10.5 Conclusion
List of abbreviations
References
Chapter 11. Pharmacogenomics and drug metabolism
Abstract
Outline
11.1 Introduction
11.2 The influence of pharmacogenomics on PK and PD
11.3 Effect of genetic variation on PK processes
11.4 Effect of genetic variability on PD and dosing regimen design
11.5 Genetic variation in CYP enzyme metabolism
11.6 Clinical applications of CYP polymorphisms
11.7 Polymorphism in enzymes
11.8 Polymorphisms in drug transporter genes
11.9 AmpliChip CYP450 test
11.10 Methods to conduct pharmacogenomics studies
11.11 Conclusion
List of abbreviations
References
Chapter 12. Revamping the pharmacokinetics of poorly soluble drugs using different formulations
Abstract
Outline
12.1 Introduction
12.2 Old drugs in a new form to enhance the pharmacokinetics of poorly water soluble drugs
12.3 Future prospective
12.4 Conclusion
List of abbreviations
References
Chapter 13. Molecular mechanisms of circadian rhythm and its influence on the pharmacokinetics of drugs
Abstract
Outline
13.1 The molecular circadian clock and its regulation
13.2 Functions of the molecular clock
13.3 Influence of physical movement on circadian rhythms
13.4 Metabolic regulation of circadian rhythms
13.5 The role of synchronizers in circadian rhythm
13.6 Monitoring of circadian rhythm and detecting techniques
13.7 Influence of circadian rhythms on the pharmacokinetics of the drug
13.8 Conclusion
List of abbreviations
References
Chapter 14. Influence of fever on pharmacokinetics of drugs
Abstract
Outline
14.1 Introduction
14.2 Effect of fever on physiological changes and their influence on the PK profile of drugs
14.3 Effect of fever on the PK of some drug classes
14.4 Conclusion
List of abbreviations
References
Chapter 15. Implications for sex-related issues in clinical pharmacology and biopharmaceutics
Abstract
Outline
15.1 Introduction
15.2 Historical review
15.3 Where men and women differ—a view of health professionals
15.4 Sex-based clinical pharmacology and PD
15.5 Adverse drug reactions in women
15.6 Sex-based biopharmaceutics and PK
15.7 Potential risk to women childbearing capacity
15.8 Medications used in pregnancy
15.9 Sex-by-formulation interactions
15.10 Policy and regulations—the new era
15.11 Conclusion
List of abbreviations
References
Further reading
Chapter 16. Bioanalytical method development and validation for establishing bioavailability and bioequivalence
Abstract
Outline
16.1 Introduction
16.2 Study design and procedures to conduct BA study
16.3 Technological developments over time in bioanalytical method development
16.4 The terminology used in bioanalytical method validation (BMV)
16.5 BMV parameters
16.6 Sample extracting techniques
16.7 Trends in bioanalytical method development and validation
16.8 Future prospectives
16.9 Conclusion
List of abbreviations
References
Chapter 17. Factors affecting the stability of drugs and their metabolites in biological matrices
Abstract
Outline
17.1 Introduction
17.2 Sources of drug instability in biological matrices
17.3 Factors affecting the drug stability in the biological matrix
17.4 Regulatory recommended stability studies for bioanalysis
17.5 Strategies to overcome the stability problems of drugs and their metabolites in biological matrices
17.6 Conclusion
List of abbreviations
References
Chapter 18. Pharmacokinetics aspects of biotechnological products
Abstract
Outline
18.1 Introduction to biotechnological products
18.2 Pitfalls in PK and or pharmacodynamics of biotechnological products
18.3 PK of protein and peptide drugs
18.4 PK of RNAi
18.5 PK of MAbs
18.6 Bioequivalence of biotechnological products
18.7 Preclinical and clinical development of MAbs, RNAi, peptide, and protein drugs
18.8 Regulatory guidance
18.9 Future prospects
18.10 Conclusion
List of abbreviations
References
Chapter 19. Factors affecting the pharmacokinetics of the liposomal drugs
Abstract
Outline
19.1 Introduction
19.2 Mechanisms of liposomal absorption through oral route
19.3 Factors affecting the pharmacokinetics of the liposomes
19.4 Conclusion
List of abbreviations
References
Chapter 20. Microdialysis: an emerging technique for pharmacokinetic–pharmacodynamic profiling
Abstract
Outline
20.1 Introduction
20.2 Features of PK–PD modeling
20.3 The principle of MD for PK–PD studies
20.4 Experimental setup of MD in rats
20.5 Preclinical and clinical application of MD for PK–PD studies
20.6 Conclusion
List of abbreviations
References
Chapter 21. Positron emission tomography as a noninvasive tool in pharmacokinetic studies
Abstract
Outline
21.1 Introduction
21.2 Principle of PET
21.3 Instrumentation of PET
21.4 Radiolabeling for PET
21.5 FDA-approved process for PET probe
21.6 Routes of administration in PET-based PK study
21.7 PET microdosing
21.8 PK of drugs with PET
21.9 Static PET acquisition
21.10 Dynamic PET acquisition
21.11 Role of PET for biodistribution and PK study of theranostic agents
21.12 Limitations of PET
21.13 Conclusion
List of abbreviations
References
Chapter 22. “Organ-on-a-chip”-based physiologically relevant pharmacokinetic models
Abstract
Outline
22.1 Introduction: organ-on-a-chip
22.2 Understanding OOAC
22.3 Key components of OOAC
22.4 Role of OOAC in physiologically based PK model
22.5 In vitro PK/PD modeling with vascularized organ chips
22.6 Determination of PK parameters using the first-pass vascularized organ chip system
22.7 Emerging OOAC technologies
22.8 In vitro–in vivo extrapolation
22.9 Fluidically coupled vascularized organ chips as a tool to quantitatively predict human PK responses
22.10 Conclusion
List of abbreviations
References
Chapter 23. Artificial intelligence in preventive and managed healthcare
Abstract
Outline
23.1 Introduction
23.2 Need for AI implementation
23.3 AI in healthcare and medicine
23.4 Conclusion
List of abbreviations
References
Chapter 24. Software used in ADME computation
Abstract
Outline
24.1 Introduction
24.2 Computational PK in drug discovery
24.3 Computational software in personalized medicine
24.4 Conclusion
List of abbreviations
References
Index

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Biopharmaceutics and Pharmacokinetics Considerations

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Rakesh Kumar Tekade

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