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Application of quantitative pharmacology analysis to support early clinical development of oncology drugs: dose

Ningyuan Zhang1, Yu Li1, Wenbin Cui1

  • 1Hansoh Pharmaceutical Group, Shanghai, China.

Xenobiotica; the Fate of Foreign Compounds in Biological Systems
|July 12, 2024
PubMed

Insights

Quantitative pharmacology analysis (QPA) offers a scientifically rigorous approach to selecting optimal starting doses for novel oncology drugs in early clinical trials. This method moves beyond traditional, risky practices to improve drug development success rates.

Area of Science:

  • Oncology Drug Development
  • Clinical Pharmacology
  • Quantitative Pharmacology Analysis (QPA)

Background:

  • Selecting appropriate starting doses and predicting efficacious doses for novel oncology drugs in early development is challenging.
  • Traditional methods like body surface area transformation and using maximum tolerated dose (MTD) or maximum administered dose (MAD) are often inadequate and risky.
  • Regulatory focus is shifting towards benefit/risk assessment for dose optimization in oncology.

Purpose of the Study:

  • To review the application of Quantitative Pharmacology Analysis (QPA) in selecting starting doses for first-in-human (FIH) oncology studies.
  • To explore QPA's role in identifying potential efficacious doses for later-phase trials (e.g., expansion or Phase 2).

Main Methods:

  • Mini-review summarizing the use of QPA in oncology drug development.
  • Integration of data across studies and development phases through QPA.
  • Focus on benefit/risk assessment-based approaches facilitated by QPA.

Main Results:

  • QPA provides a more rational and scientifically grounded method for dose selection compared to traditional approaches.
  • QPA enables the integration of diverse data to inform dose decisions.
  • This approach supports a comprehensive benefit/risk assessment crucial for modern oncology drug development.

Conclusions:

  • Quantitative Pharmacology Analysis (QPA) is pivotal in the evolving landscape of oncology drug dose selection.
  • Implementing QPA can significantly enhance clinical trial success rates.
  • QPA ultimately supports informed clinical decision-making, particularly for optimizing drug dosage.
Keywords:
Early clinical developmentdose selectiononcology drugquantitative pharmacologyquantitative system pharmacology

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