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Atkinson's Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal…mehr
Atkinson's Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology.
Presents the essential knowledge for effective practice of clinical pharmacology
Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology
Offers an extensive regulatory section that addresses US and international issues and guidelines
Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK
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Inhaltsangabe
1. Introduction to Clinical Pharmacology Arthur John Atkinson Jr., Juan J. L. Lertora and Shiew Mei Huang 2. Clinical Pharmacokinetics Arthur John Atkinson Jr. 3. Compartmental Analysis of Drug Distribution Arthur John Atkinson Jr. 4. Drug Absorption and Bioavailability Arthur John Atkinson Jr. 5. Effect of Renal Disease on Pharmacokinetics Thomas D. Nolin, Albert Dreisbach and Juan J. L. Lertora 6. Pharmacokinetics in Patients Requiring Renal Replacement Therapy Arthur John Atkinson Jr., Thomas D. Nolin and John Allen 7. Effect of Liver Disease on Pharmacokinetics Juan J. L. Lertora, Robert A. Branch and Nathalie K. Zgheib 8. Non-Compartmental and Compartmental Approaches to Pharmacokinetic Data Analysis Paolo Vicini 9. Population Pharmacokinetics Raymond Miller and Ophelia Yin 10. Pathways of Drug Metabolism Nina Isoherranen and R. Scott Obach 11. Methods of Analysis of Drugs and Drug Metabolites Mark Edward Arnold and Brian Booth 12. Clinical Pharmacogenomics Anuradha Ramamoorthy, Tristan Sissung and Michael Pacanowski 13. Mechanisms and genetics of drug transport Lei Zhang, Sook Wah Yee, Osatohanmwen Enogieru, Shiew Mei Huang and Kathleen Giacomini 14. drug-drug interactions Aleksandra Galetin, Lei Zhang, A. David Rodrigues and Shiew Mei Huang 15. Biochemical Mechanisms of Drug Toxicity Arthur John Atkinson Jr., Jack Uetrecht, Denis M. Grant and Peter G. Wells 16. pharmacogenomic mechanisms of drug toxicity Shiew Mei Huang, Ligong Chen and Kathleen Giacomini 17. Biomarkers in Drug Development Robert N. Schuck, Jana G. Delfino, Christopher Leptak and John A. Wagner 18. imaging in drug development Owen Carmichael 19. dose-effect and concentration-effect analysis Juan J. L. Lertora, Yaning Wang, Jiang Liu and Justin C. Earp 20. time course of drug response Nick Holford 21. disease progress models Diane Renee Mould, Nick Holford and Carl Peck 22. Pharmacological Differences between Men and Women Mary F. Paine and Karen Dinh Vo 23. drug therapy in pregnant and nursing women Catherine Stika and Marilynn C. Frederiksen 24. pediatric clinical pharmacology and therapeutics Bridgette Jones, John N. van den Anker, Gilbert J. Burckart and Gregory Kearns 25. Medication Therapy in Older Adults S. W. Johnny Lau, Danijela Gnjidic and Darrell Abernethy 26. clinical analysis of adverse drug reactions Christine Chamberlain, Cindy Kortepeter and Monica Munoz 27. Quality Assessment of Drug Therapy Charles Edward Daniels 28. portfolio and project planning and management in the drug discovery evaluation, development, and regulatory review process Charles V. Grudzinskas, Michael Dyszel, Khushboo Sharma and Charles T. Gombar 29. Drug Discovery Thomas Bateman 30. Non-Clinical Drug Development Chris H. Takimoto 31. pre-clinical prediction of human pharmacokinetics Malcolm Rowland 32. Phase I Clinical Studies Robert Joseph Noveck and Martina D. Sahre 33. pharmacokinetic and pharmacodynamic considerations in the development of biotechnology products and large molecules Pamela Garzone and Yow-Ming C. Wang 34. Design of Clinical Development Programs Megan Gibbs, Bengt Hamren, Helen Tomkinson, Renee Bailey Iacona and David Boulton 35. the role of the FDA in guiding drug development; Elimika Pfuma Fletcher, Rajanikanth Madabushi, Chandrahas Sahajwalla, Lawrence J. Lesko and Shiew Mei Huang 36. Emerging Clinical Pharmacology Topics in Drug Development and Precision Medicine Qi Liu, Jack A. Gilbert, Hao Zhu, Shiew Mei Huang, Elizabeth Kunkoski, Promi Das, Kimberly Bergman, Mary Buschmann and M Khair ElZarrad Appendix I Appendix II
1. Introduction to Clinical Pharmacology Arthur John Atkinson Jr., Juan J. L. Lertora and Shiew Mei Huang 2. Clinical Pharmacokinetics Arthur John Atkinson Jr. 3. Compartmental Analysis of Drug Distribution Arthur John Atkinson Jr. 4. Drug Absorption and Bioavailability Arthur John Atkinson Jr. 5. Effect of Renal Disease on Pharmacokinetics Thomas D. Nolin, Albert Dreisbach and Juan J. L. Lertora 6. Pharmacokinetics in Patients Requiring Renal Replacement Therapy Arthur John Atkinson Jr., Thomas D. Nolin and John Allen 7. Effect of Liver Disease on Pharmacokinetics Juan J. L. Lertora, Robert A. Branch and Nathalie K. Zgheib 8. Non-Compartmental and Compartmental Approaches to Pharmacokinetic Data Analysis Paolo Vicini 9. Population Pharmacokinetics Raymond Miller and Ophelia Yin 10. Pathways of Drug Metabolism Nina Isoherranen and R. Scott Obach 11. Methods of Analysis of Drugs and Drug Metabolites Mark Edward Arnold and Brian Booth 12. Clinical Pharmacogenomics Anuradha Ramamoorthy, Tristan Sissung and Michael Pacanowski 13. Mechanisms and genetics of drug transport Lei Zhang, Sook Wah Yee, Osatohanmwen Enogieru, Shiew Mei Huang and Kathleen Giacomini 14. drug-drug interactions Aleksandra Galetin, Lei Zhang, A. David Rodrigues and Shiew Mei Huang 15. Biochemical Mechanisms of Drug Toxicity Arthur John Atkinson Jr., Jack Uetrecht, Denis M. Grant and Peter G. Wells 16. pharmacogenomic mechanisms of drug toxicity Shiew Mei Huang, Ligong Chen and Kathleen Giacomini 17. Biomarkers in Drug Development Robert N. Schuck, Jana G. Delfino, Christopher Leptak and John A. Wagner 18. imaging in drug development Owen Carmichael 19. dose-effect and concentration-effect analysis Juan J. L. Lertora, Yaning Wang, Jiang Liu and Justin C. Earp 20. time course of drug response Nick Holford 21. disease progress models Diane Renee Mould, Nick Holford and Carl Peck 22. Pharmacological Differences between Men and Women Mary F. Paine and Karen Dinh Vo 23. drug therapy in pregnant and nursing women Catherine Stika and Marilynn C. Frederiksen 24. pediatric clinical pharmacology and therapeutics Bridgette Jones, John N. van den Anker, Gilbert J. Burckart and Gregory Kearns 25. Medication Therapy in Older Adults S. W. Johnny Lau, Danijela Gnjidic and Darrell Abernethy 26. clinical analysis of adverse drug reactions Christine Chamberlain, Cindy Kortepeter and Monica Munoz 27. Quality Assessment of Drug Therapy Charles Edward Daniels 28. portfolio and project planning and management in the drug discovery evaluation, development, and regulatory review process Charles V. Grudzinskas, Michael Dyszel, Khushboo Sharma and Charles T. Gombar 29. Drug Discovery Thomas Bateman 30. Non-Clinical Drug Development Chris H. Takimoto 31. pre-clinical prediction of human pharmacokinetics Malcolm Rowland 32. Phase I Clinical Studies Robert Joseph Noveck and Martina D. Sahre 33. pharmacokinetic and pharmacodynamic considerations in the development of biotechnology products and large molecules Pamela Garzone and Yow-Ming C. Wang 34. Design of Clinical Development Programs Megan Gibbs, Bengt Hamren, Helen Tomkinson, Renee Bailey Iacona and David Boulton 35. the role of the FDA in guiding drug development; Elimika Pfuma Fletcher, Rajanikanth Madabushi, Chandrahas Sahajwalla, Lawrence J. Lesko and Shiew Mei Huang 36. Emerging Clinical Pharmacology Topics in Drug Development and Precision Medicine Qi Liu, Jack A. Gilbert, Hao Zhu, Shiew Mei Huang, Elizabeth Kunkoski, Promi Das, Kimberly Bergman, Mary Buschmann and M Khair ElZarrad Appendix I Appendix II
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