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Related Concept Videos

Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
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Pharmacodynamic (PD) responses describe the interaction between a drug and its biological target, culminating in a physiological effect. These responses can be classified into different types: continuous variables, such as blood glucose levels; categorical outcomes, like survival rates; and time-to-event metrics, such as disease progression. Understanding and modeling PD responses are critical for optimizing drug efficacy and safety.PD models describe the relationship between drug concentration...
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The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

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Published on: December 11, 2016

Model-based drug development: a rational approach to efficiently accelerate drug development.

P A Milligan1, M J Brown, B Marchant

  • 1Global Clinical Pharmacology, Pfizer, Sandwich, UK. peter.a.milligan@pfizer.com

Clinical Pharmacology and Therapeutics
|April 17, 2013
PubMed
Summary
This summary is machine-generated.

Drug development faces high costs and low success rates, especially in late stages due to insufficient efficacy. Model-based drug development (MBDD) offers a strategy to optimize compound development and improve efficiency.

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Last Updated: May 12, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Biotechnology

Background:

  • The pharmaceutical industry struggles with low drug candidate success rates, leading to substantial financial losses.
  • High investment costs, exceeding $1.8 billion per successful drug, are compounded by declining new medicine output.
  • Late-stage failures in Phase II and III trials, primarily due to insufficient efficacy, represent the most significant waste in current drug development.

Purpose of the Study:

  • To explore the application of model-based drug development (MBDD) approaches.
  • To demonstrate how MBDD can accelerate and optimize compound development strategies.
  • To provide illustrative examples of MBDD in practice.

Main Methods:

  • Discussion of model-based drug development (MBDD) principles.
  • Analysis of challenges in current pharmaceutical development paradigms.
  • Case studies and examples illustrating MBDD implementation.

Main Results:

  • MBDD approaches can proactively address efficacy challenges.
  • Optimization of compound development strategies is achievable through MBDD.
  • Accelerated timelines and improved resource allocation are potential outcomes of MBDD.

Conclusions:

  • Model-based drug development (MBDD) is a viable strategy to mitigate late-stage failures.
  • MBDD enhances the efficiency and success rates of pharmaceutical R&D.
  • Implementing MBDD can lead to more predictable and cost-effective drug development pipelines.