Model-based drug development

R L Lalonde; K G Kowalski; M M Hutmacher; W Ewy; D J Nichols; P A Milligan; B W Corrigan; P A Lockwood; S A Marshall; L J Benincosa; T G Tensfeldt; K Parivar; M Amantea; P Glue; H Koide; R Miller

doi:10.1038/sj.clpt.6100235

Model-based drug development

Clin Pharmacol Ther. 2007 Jul;82(1):21-32. doi: 10.1038/sj.clpt.6100235. Epub 2007 May 23.

Authors

R L Lalonde¹, K G Kowalski, M M Hutmacher, W Ewy, D J Nichols, P A Milligan, B W Corrigan, P A Lockwood, S A Marshall, L J Benincosa, T G Tensfeldt, K Parivar, M Amantea, P Glue, H Koide, R Miller

Affiliation

¹ Department of Clinical Pharmacology, Pfizer Global Research and Development, Groton, CT, USA. richard.lalonde@pfizer.com

PMID: 17522597
DOI: 10.1038/sj.clpt.6100235

Abstract

The low productivity and escalating costs of drug development have been well documented over the past several years. Less than 10% of new compounds that enter clinical trials ultimately make it to the market, and many more fail in the preclinical stages of development. These challenges in the "critical path" of drug development are discussed in a 2004 publication by the US Food and Drug Administration. The document emphasizes new tools and various opportunities to improve drug development. One of the opportunities recommended is the application of "model-based drug development (MBDD)." This paper discusses what constitutes the key elements of MBDD and how these elements should fit together to inform drug development strategy and decision-making.

Publication types

Review

MeSH terms

Alzheimer Disease / drug therapy
Alzheimer Disease / psychology
Amines / pharmacology
Amines / therapeutic use
Analgesics / pharmacology
Analgesics / therapeutic use
Animals
Anticholesteremic Agents / pharmacology
Anticholesteremic Agents / therapeutic use
Bridged Bicyclo Compounds, Heterocyclic / pharmacology
Bridged Bicyclo Compounds, Heterocyclic / therapeutic use
Caproates / pharmacology
Caproates / therapeutic use
Cholesterol / blood
Clinical Trials as Topic / legislation & jurisprudence
Clinical Trials as Topic / methods*
Clinical Trials as Topic / statistics & numerical data
Cognition / drug effects
Computer Simulation
Cyclohexanecarboxylic Acids / pharmacology
Cyclohexanecarboxylic Acids / therapeutic use
Dose-Response Relationship, Drug*
Drug Approval*
Drug Design*
Gabapentin
Glycoproteins / pharmacology
Glycoproteins / therapeutic use
Guidelines as Topic
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / pharmacology
Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
Hypercholesterolemia / blood
Hypercholesterolemia / drug therapy
Immunologic Factors / pharmacology
Immunologic Factors / therapeutic use
Meta-Analysis as Topic
Models, Biological*
Models, Statistical
Muscarinic Agonists / pharmacology
Muscarinic Agonists / therapeutic use
Neuralgia, Postherpetic / drug therapy
Neutrophil Infiltration / drug effects
Oximes / pharmacology
Oximes / therapeutic use
Pharmacokinetics
Pharmacology*
Reproducibility of Results
Research Design*
Stroke / drug therapy
Stroke / immunology
United States
United States Food and Drug Administration
gamma-Aminobutyric Acid / pharmacology
gamma-Aminobutyric Acid / therapeutic use

Substances

Amines
Analgesics
Anticholesteremic Agents
Bridged Bicyclo Compounds, Heterocyclic
Caproates
Cyclohexanecarboxylic Acids
Glycoproteins
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Immunologic Factors
Muscarinic Agonists
Oximes
UK279276
PD 142505-0028
gamma-Aminobutyric Acid
Gabapentin
Cholesterol
gemcabene