Preclinical Drug Development, Second Edition By Mark Rogge, David R. Taft

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Preclinical Drug Development, Second Edition

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Features

 

  • chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling
  • a completely new chapter on lead molecule selection
  • lead molecule selection and optimization via profiling, and screening using in silico and in vitro toxicity evaluations
  • case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development
  • a review of ICH preclinical guidelines
  • experimental methods used to study membrane drug transport and metabolism
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    Summary

     

    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.

     

    Table of Contents

     

    The Scope of Preclinical Drug Development: An Introduction and Framework; Mark C. Rogge

    Lead Molecule Selection: Pharmaceutical Profiling and Toxicity Assessments; P. L. Bullock

    Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical

    Data to Human Populations; M. N. Martinez

    Pharmacokinetics/ADME of Small Molecules; A. D. Ajavon and David R. Taft

    Pharmacokinetics/ADME of Large Molecules; R. Braeckman

    Preclinical Pharmacokinetic–Pharmacodynamic Modeling and Simulation in Drug Development; P. L. Bonate and P. Vicini

    Formulation and Production Strategies for Enhancing Bioavailability of Poorly Absorbed Drugs; A. B. Watts and R. O. Williams III

    Transporters Involved in Drug Disposition, Toxicity, and Efficacy; C. Q. Xia and G. T. Miwa

    Toxicity Evaluations, ICH Guidelines, and Current Practice; J. L. Larson

    Application of Pathology in Safety Assessment; Robert A. Ettlin and David E. Prentice

    Utilizing the Preclinical Database to Support Clinical Drug Development; H. Lee

    Index

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