Chapter 8. Pharmacokinetics and Pharmacodynamics of Biotech Drugs

  1. Dr. Oliver Kayser,
  2. Prof. Dr. Rainer H. Müller
  1. Prof. Dr. Bernd Meibohm1,
  2. Prof. Dr. Hartmut Derendorf2

Published Online: 28 JAN 2005

DOI: 10.1002/3527602410.ch8

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

How to Cite

Meibohm, B. and Derendorf, H. (2005) Pharmacokinetics and Pharmacodynamics of Biotech Drugs, in Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications (eds O. Kayser and R. H. Müller), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, FRG. doi: 10.1002/3527602410.ch8

Editor Information

  1. Free University Berlin, Institute of Pharmacy, Pharmaceutical Technology, Biopharmacy & Biotechnology, Kelchstr. 31, 12169 Berlin, Germany

Author Information

  1. 1

    Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee, Health Science Center, Memphis, TN 38163, USA

  2. 2

    Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, FL 32610, USA

Publication History

  1. Published Online: 28 JAN 2005
  2. Published Print: 28 JAN 2004

ISBN Information

Print ISBN: 9783527305544

Online ISBN: 9783527602414

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Keywords:

  • pharmaceutical biotechnology;
  • biotech drugs;
  • pharmacodynamics of biotech drugs;
  • pharmacokinetics of peptides;
  • pharmacokinetics proteins;
  • pharmacokinetics of oligonucleotides;
  • pharmacokinetics of DNA;
  • exposure/response correlations;
  • PK/PD models

Summary

  • Introduction

  • Bioanalytical Challenges

  • Pharmacokinetics of Peptides and Proteins

    • Absorption

    • Distribution

    • Protein Binding

    • Elimination

      • Proteolysis

      • Gastrointestinal Elimination

      • Renal Elimination

      • Hepatic Elimination

      • Receptor-mediated Elimination

    • Species Specificity and Allometry

    • Immunogenicity

  • Pharmacokinetics of Oligonucleotides

  • Pharmacokinetics of DNA

  • Exposure/Response Correlations for Biotech Drugs

    • Direct Link PK/PD Models

    • Indirect Link PK/PD Models

    • Indirect Response PK/PD Models

    • Precursor Pool PK/PD Models

    • Complex PK/PD Models

  • Summary

  • References