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Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Pharmacology

  1. Bernd Meibohm1,
  2. Hartmut Derendorf2

Published Online: 15 SEP 2006

DOI: 10.1002/3527600906.mcb.200400105

Reviews in Cell Biology and Molecular Medicine

Reviews in Cell Biology and Molecular Medicine

How to Cite

Meibohm, B. and Derendorf, H. 2006. Pharmacokinetics and Pharmacodynamics of Biotech Drugs. Reviews in Cell Biology and Molecular Medicine. .

Author Information

  1. 1

    The University of Tennessee Health Science Center, Memphis, TN

  2. 2

    University of Florida, Gainesville, FL

Publication History

  1. Published Online: 15 SEP 2006

This is not the most recent version of the article. View current version (27 JUL 2015)

Abstract

In recent years, biotechnologically derived peptide- and protein-based drugs have developed into mainstream therapeutic agents. Peptide and protein drugs, as well as oligonucleotides and DNA, now constitute a substantial portion of the compounds under preclinical and clinical development in the global pharmaceutical industry. The pharmacokinetic and pharmacodynamic properties of a biotech drug determine the relationship between administered dose, resulting systemic exposure, and subsequent pharmacologic response. Pharmacokinetics, and pharmacodynamics are, therefore, frequently crucial determinants of a drug's efficacy and safety, and their evaluation is an important component during the preclinical and clinical development of a drug candidate. However, pharmacokinetic and exposure/response evaluations for peptides and protein therapeutics are frequently complicated by their similarity to endogenous peptides and proteins as well as protein nutrients. In addition, pharmacokinetic/pharmacodynamic (PK/PD) correlations for biotech drugs are frequently convoluted by their close interaction with endogenous substances and physiologic regulatory feedback mechanisms. Extensive use of pharmacokinetic and exposure/response concepts in all phases of drug development has, in the past, been identified as a crucial factor for the success of a scientifically driven, evidence-based, and hence accelerated drug development process. Thus, PK/PD concepts are likely to continue and expand their role as a fundamental factor in the successful development of biotechnologically derived drug products in the future.

Keywords:

  • Biotech Drug;
  • Absorption;
  • Distribution;
  • Elimination;
  • Excretion;
  • Metabolism;
  • Clearance (CL);
  • Volume of Distribution (Vd );
  • Exposure /Response Correlation;
  • PK/PD Model