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Pharmacokinetics and Pharmacodynamics of Biotech Drugs
Principles and Case Studies in Drug Development
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Fler böcker av Bernd Meibohm
Daan J A Crommelin, Robert D Sindelar, Bernd Meibohm
Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, includi...
Drug-Drug Interactions for Therapeutic Biologics
Honghui Zhou, Bernd Meibohm
Drug-drug interactions (DDIs) occur when a patient is exposed simultaneously to multiple pharmaceuticals, which can result in variations in drug response of the co-administered drugs. Using illustrative case studies and examples, Drug-Drug Interac...
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"... There is an urgent need to understand the PK and PD characteristics of these different types of drugs. This book meets that need. ..." Anticancer Research
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Bernd Meibohm is an Associate Professor of Pharmaceutical Sciences at the College of Pharmacy of the University of Tennessee Health Science Center, Memphis. He obtained his PhD from the University Carolo-Wilhelmina in Braunschweig, Germany, and underwent postdoctoral training in clinical pharmacology at the University of Florida, Gainesville. His research is focused on pharmacokinetics (PK), pharmacodynamics (PD), and pharmacogenetics (PG) with special emphasis on PK/PD/PG correlations. Professor Meibohm is a Fellow of the American College of Clinical Pharmacology (ACCP) and has received numerous awards, including the 'Young Investigator Award in PK, PD and Drug Metabolism' from the American Association of Pharmaceutical Scientists (AAPS) in 2000. He is currently serving as Section Editor for PK and PD for the Journal of Clinical Pharmacology and on the Editorial Boards of the Journal of Pediatric Pharmacology and Therapeutics and Die Pharmazie.
Foreword. Preface. List of Contributors. Part I: Introduction. 1 The Role of Pharmacokinetics and Pharmacodynamics in the Development of Biotech Drugs (Bernd Meibohm). 1.1 Introduction. 1.2 Biotech Drugs and the Pharmaceutical Industry. 1.3 Pharmacokinetics and Pharmacodynamics in Drug Development. 1.4 PK and PK/PD Pitfalls for Biotech Drugs. 1.5 Regulatory Guidance. 1.6 Future. 1.7 References. Part II: The Basics. 2 Pharmacokinetics of Peptides and Proteins (Lisa Tang and Bernd Meibohm). 2.1 Introduction. 2.2 Administration Pathways. 2.3 Administration Route and Immunogenicity. 2.4 Distribution. 2.5 Elimination. 2.6 Interspecies Scaling. 2.7 Conclusions. 2.8 References. 3 Pharmacokinetics of Monoclonal Antibodies (Katharina Kuester and Charlotte Kloft). 3.1 Introduction. 3.2 The Human Immune System. 3.3 Physiological Antibodies. 3.4 Therapeutic Antibodies. 3.5 Effector Functions and Modes of Action of Antibodies. 3.6 Prerequisites for mAb Therapy. 3.7 Issues in the Bioanalysis of Antibodies. 3.8 Catabolism of Antibodies. 3.9 Pharmacokinetic Characteristics of mAbs. 3.10 Pharmacokinetic Modeling of mAbs. 3.11 Pharmacodynamics of mAbs. 3.12 Conclusions. 3.13 References. 4 Pharmacokinetics and Pharmacodynamics of Antisense Oligonucleotides (Rosie Z. Yu, Richard S. Geary, and Arthur A. Levin). 4.1 Introduction. 4.2 Pharmacokinetics. 4.3 Pharmacodynamics. 4.4 Summary. 4.5 References. 5 Pharmacokinetics of Viral and Non-Viral Gene Delivery Vectors (Martin Meyer, Gururaj Rao, Ke Ren, and Jeffrey Hughes). 5.1 General Overview of Gene Therapy. 5.2 Anatomical Considerations. 5.3 Naked DNA. 5.4 Non-Viral Vectors. 5.5 Viral Vectors. 5.6 Summary. 5.7 References. Part III: Challenges and Opportunities. 6 Bioanalytical Methods Used for Pharmacokinetic Evaluations of Biotech Macromolecule Drugs: Issues, Assay Approaches, and Limitations (Jean W. Lee). 6.1 Introduction. 6.2 Bioanalytical Methods for Macromolecule Drug Analysis: Common Considerations. 6.3 The Bioanalytical Method Workhorses. 6.4 Case Studies. 6.5 Future Perspectives: Emerging Quantitative Methods. 6.6 Conclusions. 6.7 References. 7 Limitations of Noncompartmental Pharmacokinetic Analysis of Biotech Drugs (Arthur B. Straughn). 7.1 Introduction. 7.2 The Concept of Volume of Distribution. 7.3 Calculation of Vss. 7.4 Pitfalls in Calculating Vss. 7.5 Results and Discussion. 7.6 Conclusions. 7.7 References. 8 Bioequivalence of Biologics (Jeffrey S. Barrett). 8.1 Introduction. 8.2 Prevailing Opinion: Science, Economics, and Politics. 8.3 Biologics: Time Course of Immunogenicity. 8.4 Pharmaceutical Equivalence. 8.5 Bioequivalence: Metrics and Methods for Biologics? 8.6 Case Study: Low-Molecular-Weight Heparins. 8.7 Conclusions. 8.8 References. 9 Biopharmaceutical Challenges: Pulmonary Delivery of Proteins and Peptides (Kun Cheng and Ram I. Mahato). 9.1 Introduction. 9.2 Structure and Physiology of the Pulmonary System. 9.3 Barriers to Pulmonary Absorption of Peptides and Proteins. 9.4 Strategies for Pulmonary Delivery. 9.5 Experimental Models. 9.6 Pulmonary Delivery of Peptides and Proteins. 9.7 Limitations of Aerosol Delivery. 9.8 Summary. 9.9 References. 10 Biopharmaceutical Challenges: Delivery of Oligonucleotides (Lloyd G. Tillman and Gregory E. Hardee). 10.1 Introduction. 10.2 ASOs: The Physico-Chemical Properties. 10.3 Local Administration. 10.4 Systemic Delivery. 10.5 Conclusions. 10.6 References. 11 Custom-Tailored Pharmacokinetics and Pharmacodynamics via Chemical Modifications of Biotech Drugs (Francesco M. Veronese and Paolo Caliceti). 11.1 Introduction. 11.2 Polymers Used in Biotechnological Drug PEGylation. 11.3 Advantages of PEG as Drug Carrier. 11.4 Chemical Aspects Critical for the P