Study design and simulation approach

Stephanie Läer, Bernd Meibohm

Research output: Chapter in Book/Report/Conference proceedingChapter

3 Citations (Scopus)

Abstract

Modeling and simulation techniques are a mainstay of clinical drug development and are particularly useful to support clinical trials in children. If a pediatrician wants to use these tools most efficiently, a basic understanding of the principles and methods of classical and novel techniques of modeling and simulation is essential. Key elements comprise the definition and description of terms like deterministic simulation, Monte Carlo simulation, classical "top down" or novel "bottom up" approach, as well as the term "virtual world simulation." The illustrated examples in this chapter from pediatric clinical trials will help to understand and demonstrate these key elements. The importance of the understanding of developmental physiology and pharmacokinetics will become visible when explaining novel "bottom up" approaches like physiologically based pharmacokinetic simulations which also bridge to current research tools from other areas such as systems biology using mathematical models to describe biological systems.

Original languageEnglish (US)
Title of host publicationPediatric Clinical Pharmacology
Pages125-148
Number of pages24
DOIs
StatePublished - Oct 31 2011

Publication series

NameHandbook of Experimental Pharmacology
Volume205
ISSN (Print)0171-2004
ISSN (Electronic)1865-0325

Fingerprint

Pharmacokinetics
Clinical Trials
Pediatrics
Systems Biology
Physiology
Biological systems
Theoretical Models
Mathematical models
Research
Pharmaceutical Preparations
Monte Carlo simulation
Pediatricians

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Läer, S., & Meibohm, B. (2011). Study design and simulation approach. In Pediatric Clinical Pharmacology (pp. 125-148). (Handbook of Experimental Pharmacology; Vol. 205). https://doi.org/10.1007/978-3-642-20195-0_6

Study design and simulation approach. / Läer, Stephanie; Meibohm, Bernd.

Pediatric Clinical Pharmacology. 2011. p. 125-148 (Handbook of Experimental Pharmacology; Vol. 205).

Research output: Chapter in Book/Report/Conference proceedingChapter

Läer, S & Meibohm, B 2011, Study design and simulation approach. in Pediatric Clinical Pharmacology. Handbook of Experimental Pharmacology, vol. 205, pp. 125-148. https://doi.org/10.1007/978-3-642-20195-0_6
Läer S, Meibohm B. Study design and simulation approach. In Pediatric Clinical Pharmacology. 2011. p. 125-148. (Handbook of Experimental Pharmacology). https://doi.org/10.1007/978-3-642-20195-0_6
Läer, Stephanie ; Meibohm, Bernd. / Study design and simulation approach. Pediatric Clinical Pharmacology. 2011. pp. 125-148 (Handbook of Experimental Pharmacology).
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