Concepts and challenges in quantitative pharmacology and model-based drug development

Liping Zhang, Marc Pfister, Bernd Meibohm

Research output: Contribution to journalArticle

66 Citations (Scopus)

Abstract

Model-based drug development (MBDD) has been recognized as a concept to improve the efficiency of drug development. The acceptance of MBDD from regulatory agencies, industry, and academia has been growing, yet today's drug development practice is still distinctly distant from MBDD. This manuscript is aimed at clarifying the concept of MBDD and proposing practical approaches for implementing MBDD in the pharmaceutical industry. The following concepts are defined and distinguished: PK-PD modeling, exposure-response modeling, pharmacometrics, quantitative pharmacology, and MBDD. MBDD is viewed as a paradigm and a mindset in which models constitute the instruments and aims of drug development efforts. MBDD covers the whole spectrum of the drug development process instead of being limited to a certain type of modeling technique or application area. The implementation of MBDD requires pharmaceutical companies to foster innovation and make changes at three levels: (1) to establish mindsets that are willing to get acquainted with MBDD, (2) to align processes that are adaptive to the requirements of MBDD, and (3) to create a closely collaborating organization in which all members play a role in MBDD. Pharmaceutical companies that are able to embrace the changes MBDD poses will likely be able to improve their success rate in drug development, and the beneficiaries will ultimately be the patients in need.

Original languageEnglish (US)
Pages (from-to)552-559
Number of pages8
JournalAAPS Journal
Volume10
Issue number4
DOIs
StatePublished - Dec 1 2008

Fingerprint

Pharmacology
Pharmaceutical Preparations
Drug Industry
Industry

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science
  • Medicine(all)

Cite this

Concepts and challenges in quantitative pharmacology and model-based drug development. / Zhang, Liping; Pfister, Marc; Meibohm, Bernd.

In: AAPS Journal, Vol. 10, No. 4, 01.12.2008, p. 552-559.

Research output: Contribution to journalArticle

Zhang, Liping ; Pfister, Marc ; Meibohm, Bernd. / Concepts and challenges in quantitative pharmacology and model-based drug development. In: AAPS Journal. 2008 ; Vol. 10, No. 4. pp. 552-559.
@article{1d440ef700d44b49875d4ed54a926ef2,
title = "Concepts and challenges in quantitative pharmacology and model-based drug development",
abstract = "Model-based drug development (MBDD) has been recognized as a concept to improve the efficiency of drug development. The acceptance of MBDD from regulatory agencies, industry, and academia has been growing, yet today's drug development practice is still distinctly distant from MBDD. This manuscript is aimed at clarifying the concept of MBDD and proposing practical approaches for implementing MBDD in the pharmaceutical industry. The following concepts are defined and distinguished: PK-PD modeling, exposure-response modeling, pharmacometrics, quantitative pharmacology, and MBDD. MBDD is viewed as a paradigm and a mindset in which models constitute the instruments and aims of drug development efforts. MBDD covers the whole spectrum of the drug development process instead of being limited to a certain type of modeling technique or application area. The implementation of MBDD requires pharmaceutical companies to foster innovation and make changes at three levels: (1) to establish mindsets that are willing to get acquainted with MBDD, (2) to align processes that are adaptive to the requirements of MBDD, and (3) to create a closely collaborating organization in which all members play a role in MBDD. Pharmaceutical companies that are able to embrace the changes MBDD poses will likely be able to improve their success rate in drug development, and the beneficiaries will ultimately be the patients in need.",
author = "Liping Zhang and Marc Pfister and Bernd Meibohm",
year = "2008",
month = "12",
day = "1",
doi = "10.1208/s12248-008-9062-3",
language = "English (US)",
volume = "10",
pages = "552--559",
journal = "AAPS Journal",
issn = "1550-7416",
publisher = "Springer New York",
number = "4",

}

TY - JOUR

T1 - Concepts and challenges in quantitative pharmacology and model-based drug development

AU - Zhang, Liping

AU - Pfister, Marc

AU - Meibohm, Bernd

PY - 2008/12/1

Y1 - 2008/12/1

N2 - Model-based drug development (MBDD) has been recognized as a concept to improve the efficiency of drug development. The acceptance of MBDD from regulatory agencies, industry, and academia has been growing, yet today's drug development practice is still distinctly distant from MBDD. This manuscript is aimed at clarifying the concept of MBDD and proposing practical approaches for implementing MBDD in the pharmaceutical industry. The following concepts are defined and distinguished: PK-PD modeling, exposure-response modeling, pharmacometrics, quantitative pharmacology, and MBDD. MBDD is viewed as a paradigm and a mindset in which models constitute the instruments and aims of drug development efforts. MBDD covers the whole spectrum of the drug development process instead of being limited to a certain type of modeling technique or application area. The implementation of MBDD requires pharmaceutical companies to foster innovation and make changes at three levels: (1) to establish mindsets that are willing to get acquainted with MBDD, (2) to align processes that are adaptive to the requirements of MBDD, and (3) to create a closely collaborating organization in which all members play a role in MBDD. Pharmaceutical companies that are able to embrace the changes MBDD poses will likely be able to improve their success rate in drug development, and the beneficiaries will ultimately be the patients in need.

AB - Model-based drug development (MBDD) has been recognized as a concept to improve the efficiency of drug development. The acceptance of MBDD from regulatory agencies, industry, and academia has been growing, yet today's drug development practice is still distinctly distant from MBDD. This manuscript is aimed at clarifying the concept of MBDD and proposing practical approaches for implementing MBDD in the pharmaceutical industry. The following concepts are defined and distinguished: PK-PD modeling, exposure-response modeling, pharmacometrics, quantitative pharmacology, and MBDD. MBDD is viewed as a paradigm and a mindset in which models constitute the instruments and aims of drug development efforts. MBDD covers the whole spectrum of the drug development process instead of being limited to a certain type of modeling technique or application area. The implementation of MBDD requires pharmaceutical companies to foster innovation and make changes at three levels: (1) to establish mindsets that are willing to get acquainted with MBDD, (2) to align processes that are adaptive to the requirements of MBDD, and (3) to create a closely collaborating organization in which all members play a role in MBDD. Pharmaceutical companies that are able to embrace the changes MBDD poses will likely be able to improve their success rate in drug development, and the beneficiaries will ultimately be the patients in need.

UR - http://www.scopus.com/inward/record.url?scp=65549156693&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65549156693&partnerID=8YFLogxK

U2 - 10.1208/s12248-008-9062-3

DO - 10.1208/s12248-008-9062-3

M3 - Article

VL - 10

SP - 552

EP - 559

JO - AAPS Journal

JF - AAPS Journal

SN - 1550-7416

IS - 4

ER -