Drug-Drug Interactions in Pharmaceutical Development
(Sprache: Englisch)
Early evaluation of potential drug-drug interactions
Addressing the potential for adverse interactions among coadministered drugs before marketing a new drug can save time, money, and lives. In this reference, distinguished international experts...
Addressing the potential for adverse interactions among coadministered drugs before marketing a new drug can save time, money, and lives. In this reference, distinguished international experts...
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Klappentext zu „Drug-Drug Interactions in Pharmaceutical Development “
Early evaluation of potential drug-drug interactionsAddressing the potential for adverse interactions among coadministered drugs before marketing a new drug can save time, money, and lives. In this reference, distinguished international experts comprehensively review the issues, relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. Focusing on evaluation during the drug discovery process, Drug-Drug Interactions in Pharmaceutical Development:
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Details the major scientific concepts and preclinical experimental approaches
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Covers both clinical and nonclinical aspects
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Discusses in vitro and in vivo methodologies
*
Covers genomic approaches
*
Addresses U.S., European, and Japanese regulations
*
Includes a chapter on herbal drug interactions
Compiling current information into one accessible resource, this is an excellent reference for industrial scientists and regulatory specialists in drug development as well as academic researchers and students in the fields of pharmacology, drug metabolism, and toxicology.
Early evaluation of potential drug-drug interactions
Addressing the potential for adverse interactions among coadministered drugs before marketing a new drug can save time, money, and lives. In this reference, distinguished international experts comprehensively review the issues, relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. Focusing on evaluation during the drug discovery process, Drug-Drug Interactions in Pharmaceutical Development:
- Details the major scientific concepts and preclinical experimental approaches
- Covers both clinical and nonclinical aspects
- Discusses in vitro and in vivo methodologies
- Covers genomic approaches
- Addresses U.S., European, and Japanese regulations
- Includes a chapter on herbal drug interactions
Compiling current information into one accessible resource, this is an excellent reference for industrial scientists and regulatory specialists in drug development as well as academic researchers and students in the fields of pharmacology, drug metabolism, and toxicology.
Addressing the potential for adverse interactions among coadministered drugs before marketing a new drug can save time, money, and lives. In this reference, distinguished international experts comprehensively review the issues, relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. Focusing on evaluation during the drug discovery process, Drug-Drug Interactions in Pharmaceutical Development:
- Details the major scientific concepts and preclinical experimental approaches
- Covers both clinical and nonclinical aspects
- Discusses in vitro and in vivo methodologies
- Covers genomic approaches
- Addresses U.S., European, and Japanese regulations
- Includes a chapter on herbal drug interactions
Compiling current information into one accessible resource, this is an excellent reference for industrial scientists and regulatory specialists in drug development as well as academic researchers and students in the fields of pharmacology, drug metabolism, and toxicology.
Inhaltsverzeichnis zu „Drug-Drug Interactions in Pharmaceutical Development “
- Preface- Contributors
1 In Vitro Evaluation of Metabolic Drug-Drug Interactions: Concepts and Practice (Albert P. Li)
1.1 Introduction
1.2 Mechanisms of Adverse Drug-Drug Interactions
1.3 Drug Metabolism
1.4 CYP Isoforms
1.5 Human In Vitro Experimental Systems for Drug Metabolism
1.6 Mechanisms of Metabolic Drug-Drug Interactions
1.7 Mechanism-Based Approach for Evaluation of Drug-Drug Interaction Potential
1.8 Experimental Approaches for In Vitro Evaluation of Drug-Drug Interaction Potential
1.9 Data Interpretation
1.10 Conclusion
- References
2 In Vitro Approaches to Anticipating Clinical Drug Interactions (Laurie P. Volak, David J. Greenblatt, and Lisa L. von Moltke)
2.1 In Vitro Systems for Human CYP450 Metabolism
2.2 Analysis of Data from In Vitro Systems
2.3 Use of In Vitro Kinetic Data to Predict In Vivo Clearance
2.4 Use of In Vitro Kinetic Data to Predict Drug-Drug Interactions
2.5 Consideration of Non-CYP Enzymatic Systems
2.6 Summary
2.7 Acknowledgments
- References
3 Inhibition of Drug-Metabolizing Enzymes and Drug-Drug Interactions in Drug Discovery and Development (R. Scott Obach)
3.1 Introduction
3.2 Laboratory Approaches Inhibiting Drug-Metabolizing Enzymes
3.3 Selection of Substrates for Inhibition Experiments in Drug Metabolism
3.4 Inhibition of Drug-Metabolizing Enzymes in Drug Discovery and Development
3.5 Summary
- References
4 Mechanism-Based CYP Inhibition: Enzyme Kinetics, Assays, and Prediction of Human Drug-Drug Interactions (Magang Shou)
4.1 Kinetic Model for Mechanism-Based Inhibition
4.2 Methodological Measurements of Kinetic Parameters
4.3 Incubation
4.4 Prediction of Human DDIs from In Vitro MBI Data
4.5 Acknowledgments
- References
5 Genomic Approaches To Drug-Drug Interactions (Yi Yang and Jeffrey F. Waring)
5.1 Introduction
5.2 DNA Microarrays
5.3 Genomic Application Toward the Prediction of DDIs
5.4 Genomics Approach to Decipher the Molecular Basis of DDI: Nuclear Receptors
5.5
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Genomic Approaches to Address the Genetic Variability in DDIs
5.6 Conclusion
- References
6 Transporters and Drug Interactions (Yoshihisa Shitara, Toshiharu Horie, and Yuichi Sugiyama)
6.1 Introduction
6.2 Interactions Involving Liver Transporters
6.3 Interactions in Intestine Transporters
6.4 Drug Toxicity Involving Drug Transporters
6.5 Drugs that Affect the Expression or Localization of Transporters
6.6 Conclusion
- References
7 Transporter-Mediated Drug Interactions: Molecular Mechanisms and Clinical Implications (Jiunn H. Lin)
7.1 Introduction
7.2 Tissue Distribution and Cellular Location of Transporters
7.3 Molecular Mechanisms for Transporter Inhibition and Induction
7.4 Drug Interactions Caused by Transporter Inhibition and Induction
7.5 Clinical Significance of Transporter-Mediated Drug Interactions
7.6 Conclusion
- References
8 Recent Case Studies of Clinically Significant Drug-Drug Interactions and the Limits of In Vitro Prediction Methodology (René H. Levy, Isabelle Ragueneau-Majlessi, and Carol Collins)
8.1 Introduction
8.2 Case Studies
- References
9 U.S. Regulatory Perspective: Drug-Drug Interactions (John Strong and Shiew-Mei Huang)
9.1 Introduction
9.2 An Integrated Approach
9.3 Methods for Evaluating Metabolic Clearance In Vitro
9.4 In Vivo Approaches
9.5 Clinical Cases
9.6 Regulatory Considerations
9.7 Labeling
9.8 Summary
- References
10 Herbal Drug Interactions--A Canadian Perspective (Brian C. Foster)
10.1 Introduction
10.2 Interaction Risk Determination
10.3 NHP Products
10.4 Disposition
10.5 PD and PK interactions
10.6 Action
- References
- Index
- Wiley Series in Drug Discovery and Development
5.6 Conclusion
- References
6 Transporters and Drug Interactions (Yoshihisa Shitara, Toshiharu Horie, and Yuichi Sugiyama)
6.1 Introduction
6.2 Interactions Involving Liver Transporters
6.3 Interactions in Intestine Transporters
6.4 Drug Toxicity Involving Drug Transporters
6.5 Drugs that Affect the Expression or Localization of Transporters
6.6 Conclusion
- References
7 Transporter-Mediated Drug Interactions: Molecular Mechanisms and Clinical Implications (Jiunn H. Lin)
7.1 Introduction
7.2 Tissue Distribution and Cellular Location of Transporters
7.3 Molecular Mechanisms for Transporter Inhibition and Induction
7.4 Drug Interactions Caused by Transporter Inhibition and Induction
7.5 Clinical Significance of Transporter-Mediated Drug Interactions
7.6 Conclusion
- References
8 Recent Case Studies of Clinically Significant Drug-Drug Interactions and the Limits of In Vitro Prediction Methodology (René H. Levy, Isabelle Ragueneau-Majlessi, and Carol Collins)
8.1 Introduction
8.2 Case Studies
- References
9 U.S. Regulatory Perspective: Drug-Drug Interactions (John Strong and Shiew-Mei Huang)
9.1 Introduction
9.2 An Integrated Approach
9.3 Methods for Evaluating Metabolic Clearance In Vitro
9.4 In Vivo Approaches
9.5 Clinical Cases
9.6 Regulatory Considerations
9.7 Labeling
9.8 Summary
- References
10 Herbal Drug Interactions--A Canadian Perspective (Brian C. Foster)
10.1 Introduction
10.2 Interaction Risk Determination
10.3 NHP Products
10.4 Disposition
10.5 PD and PK interactions
10.6 Action
- References
- Index
- Wiley Series in Drug Discovery and Development
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Autoren-Porträt von Binghe Wang
Albert P. Li is the President and CEO of In Vitro ADMET Laboratories, LLC (www.invitroadmet.com), and Advanced Pharmaceutical Sciences, Inc. (www.apsciences.com), and the cofounder, Chairman, and CSO of the ADMET Group (www.admetgroup.com). Dr. Li has over twenty-five years in the drug development industry, is a distinguished international speaker in the field, and has over 150 publications. He has edited several books.
Bibliographische Angaben
- Autor: Binghe Wang
- 2007, 1. Auflage, 264 Seiten, Masse: 16,1 x 24 cm, Gebunden, Englisch
- Herausgegeben: Albert P. Li
- Verlag: Wiley & Sons
- ISBN-10: 0471794414
- ISBN-13: 9780471794417
- Erscheinungsdatum: 30.10.2007
Sprache:
Englisch
Rezension zu „Drug-Drug Interactions in Pharmaceutical Development “
"I am pleased to have read this book from cover-to-cover. I will value owning it and keep it near the front of my bookshelf" ( Good Clinical Practice Journal , June 2008)
Pressezitat
"I am pleased to have read this book from cover-to-cover. I will value owning it and keep it near the front of my bookshelf" ( Good Clinical Practice Journal , June 2008)
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