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Preclinical Drug Development 2nd Edition by Mark Rogge, David R Taft ISBN 1420084720 9781420084726

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Preclinical Drug Development Second Edition Drugs and the Pharmaceutical Sciences Vol 187 Mark Rogge Digital Instant Download

Author(s): Mark Rogge, David R. Taft
ISBN(s): 9781420084726, 1420084720
Edition: 2
File Details: PDF, 3.14 MB
Year: 2009
Language: english
SKU: EB-1841020 Category: Tags: ,

Preclinical Drug Development 2nd Edition by Mark Rogge, David R Taft – Ebook PDF Instant Download/Delivery: 1420084720, 9781420084726
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ISBN 10: 1420084720
ISBN 13: 9781420084726
Author: Mark Rogge, David R Taft

Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: Pharmacokinetics Modeling and simulation Formulation and routes of administration Toxicity evaluations The assessment of drug absorption and metabolism Interspecies scaling Lead molecule selection and optimization via profiling Screening using in silico and in vitro toxicity evaluations The book also includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

Preclinical Drug Development 2nd Table of contents:

1. The Scope of Preclinical Drug Development: An Introduction and Framework

  • References

2. Lead Molecule Selection: Pharmaceutical Profiling and Toxicity Assessments

  • Introduction

  • The Emergence of Lead Selection in Drug Discovery

  • Lead Selection by Pharmaceutical Profiling

  • Toxicity Assessments

  • Conclusion

  • Acknowledgements

  • References

3. Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical Data to Human Populations

  • Overview

  • Toxicology Tests: Points to Consider

  • Pharmacology

  • Interspecies Pharmacokinetic Differences

  • Allometry

  • Concluding Thoughts

  • References

4. Pharmacokinetics/ADME of Small Molecules

  • Introduction

  • Absorption, Distribution, Metabolism, and Excretion Mechanisms

  • Bioavailability

  • Drug Interactions

  • Physiologic & Genetic Factors

  • Species Differences

  • Conclusion

  • References

5. Pharmacokinetics/ADME of Large Molecules

  • Introduction

  • Clearance & Metabolism Mechanisms

  • Distribution & Binding

  • Interspecies Scaling

  • Heterogeneity, Modifications, and Immunogenicity

  • Conclusions and Implications

  • References

6. Preclinical Pharmacokinetic–Pharmacodynamic Modeling and Simulation in Drug Development

  • Introduction

  • What is Model-Based Drug Development?

  • Case Studies

  • Closing Thoughts

  • Acknowledgements

  • References

7. Formulation and Production Strategies for Enhancing Bioavailability of Poorly Absorbed Drugs

  • Introduction

  • Nanoparticles, Micelles, Cyclodextrins, Carrier Dispersions

  • Delivery Routes: Oral, Pulmonary, IV, Nasal

  • Self-Emulsifying Systems and Solid Lipid Nanoparticles

  • Processing Technology and Applications

  • Conclusion

  • References

8. Transporters Involved in Drug Disposition, Toxicity, and Efficacy

  • Introduction

  • Role of Transporters in Absorption, Distribution, Metabolism, Excretion

  • Drug-Drug Interactions (DDIs)

  • Toxicity, Resistance, Efficacy, and Targeting

  • Transporter Polymorphisms

  • Conclusions and Perspectives

  • Acknowledgments

  • References

9. Toxicity Evaluations, ICH Guidelines, and Current Practice

  • Chapter Overview

  • ICH Guidelines: Structure and Implementation

  • Toxicity Study Types (Single-dose, Repeat-dose, Reproductive, Genotoxicity, Carcinogenicity)

  • Safety Pharmacology & Toxicokinetics

  • Case Studies: Celebrex, Herceptin, Rituxan, Remicade

  • Conclusions

  • Appendix: Websites of Interest

  • References

10. Application of Pathology in Safety Assessment

  • Introduction to Pathology in Drug Development

  • Methods: Clinical & Postmortem Pathology

  • Histological Evaluation

  • General and Tumor Pathology

  • Species Specificity

  • Interpretation and Reporting of Findings

  • Conclusions

  • Acknowledgments

  • References

11. Utilizing the Preclinical Database to Support Clinical Drug Development

  • Selecting Human Dose

  • Regulatory Perspectives and Mechanistic Approaches

  • Efficacy and Safety Support

  • Designing Metabolic DDI Studies

  • Limitations and Predictive Value

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Tags: Mark Rogge, David R Taft, Preclinical Drug