Tools for predicting the PK/PD of therapeutic proteins

Lei Diao, Bernd Meibohm

Research output: Contribution to journalReview article

6 Citations (Scopus)

Abstract

Introduction: Assessments of the pharmacokinetic/pharmacodynamic (PK/PD) characteristics are an integral part in the development of novel therapeutic agents. Compared with traditional small molecule drugs, therapeutic proteins possess many distinct PK/PD features that necessitate the application of modified or separate approaches for assessing their PK/PD relationships.Areas covered: In this review, the authors discuss tools that are utilized to describe and predict the PK/PD features of therapeutic proteins and that are valuable additions in the armamentarium of drug development approaches to facilitate and accelerate their successful preclinical and clinical development.Expert opinion: A variety of state-of-the-art PK/PD tools is currently being applied and has been adjusted to support the development of proteins as therapeutics, including allometric scaling approaches, target-mediated disposition models, first-in-man dose calculations, physiologically based PK models and empirical and semi-mechanistic PK/PD modeling. With the advent of the next generation of biologics including bioengineered antibody constructs being developed, these tools will need to be further refined and adapted to ensure their applicability and successful facilitation of the drug development process for these novel scaffolds.

Original languageEnglish (US)
Pages (from-to)1115-1125
Number of pages11
JournalExpert Opinion on Drug Metabolism and Toxicology
Volume11
Issue number7
DOIs
StatePublished - Jul 1 2015

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Pharmacodynamics
Pharmacokinetics
Proteins
Therapeutics
Pharmaceutical Preparations
Expert Testimony
Biological Products
Scaffolds
Molecules
Antibodies

All Science Journal Classification (ASJC) codes

  • Toxicology
  • Pharmacology

Cite this

Tools for predicting the PK/PD of therapeutic proteins. / Diao, Lei; Meibohm, Bernd.

In: Expert Opinion on Drug Metabolism and Toxicology, Vol. 11, No. 7, 01.07.2015, p. 1115-1125.

Research output: Contribution to journalReview article

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