Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Model-based drug development.

R L Lalonde1, K G Kowalski, M M Hutmacher

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

Clinical Pharmacology and Therapeutics
|May 25, 2007
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

In vitro comparative study on the mechanical behavior of Zirconia and Polyetheretherketone in applied dental sciences.

European review for medical and pharmacological sciences·2023
Same author

Forced Suppression of let-7a-5p in Mouse Blastocysts Improves Implantation Rate.

Reproductive sciences (Thousand Oaks, Calif.)·2021
Same author

The effects of Finasteride on the expression of Dazl, Tsga10, Sycp3, Prm2 genes during spermatogenesis in testes of NMRI mice.

European review for medical and pharmacological sciences·2020
Same author

The alteration of stress-related physiological parameters after probiotics administration in oral surgeons with different degrees of surgical experience.

La Clinica terapeutica·2020
Same author

The effect of maternal sleep deprivation on differentiation of mesenchymal stem cells in the presence of neonates brain cerebrospinal fluid of Wistar rats.

Bratislavske lekarske listy·2020
Same author

PRDM14 promotes malignant phenotype and correlates with poor prognosis in colorectal cancer.

Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·2019
Same journal

Symposium Report: Stakeholders' Perspectives on Phase 1 Trials in Japanese Prior to Multi-Regional Clinical Trials and Future Pathways.

Clinical pharmacology and therapeutics·2026
Same journal

Resolving CYP2D6 Structural Complexity with Long-Read Sequencing: Implications for Tamoxifen Precision Dosing in Thai Breast Cancer Patients.

Clinical pharmacology and therapeutics·2026
Same journal

Identification of a Functional CYP2C8 Variant Allele that Alters Splicing, Reduces Protein Expression, and Increases Drug Exposure.

Clinical pharmacology and therapeutics·2026
Same journal

Risk of Hyperkalemia in Patients with Heart Failure Treated with Spironolactone in Combination with Sacubitril/Valsartan vs. Renin-Angiotensin System Inhibitors.

Clinical pharmacology and therapeutics·2026
Same journal

Composite Endpoints in Contemporary Cardiovascular Trials: Trends in Phase 3 Trials and Key Issues in Regulatory Review.

Clinical pharmacology and therapeutics·2026
Same journal

Patient-Specific Determinants of Response to BCMA- and GPRC5D-Targeted CAR T-Cell Therapy in Multiple Myeloma: A QSP Analysis of Clinical Trial and Real-World Data.

Clinical pharmacology and therapeutics·2026
See all related articles

Model-based drug development (MBDD) offers a strategic approach to overcome the low productivity and high costs in pharmaceutical research. This method integrates key elements to enhance decision-making throughout the drug development process.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Discovery and Development
  • Regulatory Science

Background:

  • Drug development faces significant challenges, including low success rates (less than 10% of compounds reach market) and escalating costs.
  • Many drug candidates fail during preclinical and clinical trial stages, impacting the efficiency of the drug development pipeline.
  • A 2004 US Food and Drug Administration (FDA) publication highlighted these critical path issues and recommended new strategies.

Purpose of the Study:

  • To define the core components of model-based drug development (MBDD).
  • To explain how these MBDD elements can be integrated to improve drug development strategy.
  • To provide a framework for informed decision-making in pharmaceutical research and development.

Main Methods:

Related Experiment Videos

  • Review and synthesis of existing literature and FDA recommendations on drug development optimization.
  • Conceptual framework development for integrating MBDD principles.
  • Analysis of how MBDD elements contribute to strategic decision-making.

    • Main Results:

    • Identification of key elements constituting MBDD.
    • A proposed structure for how these elements interact and inform development strategy.
    • Emphasis on the potential of MBDD to address productivity and cost issues.

    Conclusions:

    • Model-based drug development (MBDD) presents a viable opportunity to enhance the efficiency and success rate of pharmaceutical R&D.
    • Integrating MBDD principles can lead to more informed strategic decisions, optimizing the drug development pathway.
    • The framework discussed provides a foundation for implementing MBDD in practice.