title: Model-based drug development.
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.
authors.affiliation: Department of Clinical Pharmacology, Pfizer Global Research and Development, Groton, CT, USA. richard.lalonde@pfizer.com
authors.forename: R L
authors.initials: RL
authors.lastname: Lalonde
authors.forename: K G
authors.initials: KG
authors.lastname: Kowalski
authors.forename: M M
authors.initials: MM
authors.lastname: Hutmacher
authors.forename: W
authors.initials: W
authors.lastname: Ewy
authors.forename: D J
authors.initials: DJ
authors.lastname: Nichols
authors.forename: P A
authors.initials: PA
authors.lastname: Milligan
authors.forename: B W
authors.initials: BW
authors.lastname: Corrigan
authors.forename: P A
authors.initials: PA
authors.lastname: Lockwood
authors.forename: S A
authors.initials: SA
authors.lastname: Marshall
authors.forename: L J
authors.initials: LJ
authors.lastname: Benincosa
authors.forename: T G
authors.initials: TG
authors.lastname: Tensfeldt
authors.forename: K
authors.initials: K
authors.lastname: Parivar
authors.forename: M
authors.initials: M
authors.lastname: Amantea
authors.forename: P
authors.initials: P
authors.lastname: Glue
authors.forename: H
authors.initials: H
authors.lastname: Koide
authors.forename: R
authors.initials: R
authors.lastname: Miller
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy / Q000523:psychology; D000588:Amines / Q000494:pharmacology / Q000627:therapeutic use; D000700:Analgesics / Q000494:pharmacology / Q000627:therapeutic use; D000818:Animals; D000924:Anticholesteremic Agents / Q000494:pharmacology / Q000627:therapeutic use; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000494:pharmacology / Q000627:therapeutic use; D002208:Caproates / Q000494:pharmacology / Q000627:therapeutic use; D002784:Cholesterol / Q000097:blood; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D003071:Cognition / Q000187:drug effects; D003198:Computer Simulation; D003509:Cyclohexanecarboxylic Acids / Q000494:pharmacology / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D015195:Drug Design; D000077206:Gabapentin; D006023:Glycoproteins / Q000494:pharmacology / Q000627:therapeutic use; D017408:Guidelines as Topic; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy; D007155:Immunologic Factors / Q000494:pharmacology / Q000627:therapeutic use; D015201:Meta-Analysis as Topic; D008954:Models, Biological; D015233:Models, Statistical; D018721:Muscarinic Agonists / Q000494:pharmacology / Q000627:therapeutic use; D051474:Neuralgia, Postherpetic / Q000188:drug therapy; D020556:Neutrophil Infiltration / Q000187:drug effects; D010091:Oximes / Q000494:pharmacology / Q000627:therapeutic use; D010599:Pharmacokinetics; D010600:Pharmacology; D015203:Reproducibility of Results; D012107:Research Design; D020521:Stroke / Q000188:drug therapy / Q000276:immunology; D014481:United States; D014486:United States Food and Drug Administration; D005680:gamma-Aminobutyric Acid / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000588:Amines; D000700:Analgesics; D000924:Anticholesteremic Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D002208:Caproates; D003509:Cyclohexanecarboxylic Acids; D006023:Glycoproteins; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007155:Immunologic Factors; D018721:Muscarinic Agonists; D010091:Oximes; C476006:UK279276; C096405:PD 142505-0028; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D002784:Cholesterol; C111024:gemcabene