Related Experiment Video

Updated: May 6, 2026

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
08:52

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids

Published on: November 22, 2021

6.0K

Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology

Ye Xiong1, Robyn Konicki1, Jeanne Fourie Zirkelbach2

  • 1Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

The Oncologist
|May 4, 2026
PubMed

Insights

Model-informed drug development (MIDD) optimizes oncology drug dosage by integrating diverse data, improving benefit-risk balance and potentially reducing the need for postmarketing studies. This approach enhances early dosage selection for better clinical outcomes.

Area of Science:

  • Oncology
  • Pharmacometrics
  • Drug Development

Background:

  • Conventional oncology dose-finding studies often result in suboptimal dosage selection.
  • This can lead to insufficient clinical data for optimal benefit-risk assessment, necessitating postmarketing studies.

Purpose of the Study:

  • To review the utilization of model-informed drug development (MIDD) for optimizing oncology drug dosage.
  • To highlight the unique challenges associated with applying MIDD in this field.

Main Methods:

  • Leveraging model-based approaches with clinical and non-clinical data.
  • Utilizing modeling and simulation techniques, including quantitative systems pharmacology and PK/PD models.
  • Employing integrative exposure-response analysis.

Main Results:

  • MIDD significantly enhances dosage selection and optimization in oncology.
  • Model-based approaches can improve the benefit-risk balance of oncology products.
  • Early identification of optimized dosages can streamline drug development.

Conclusions:

  • MIDD is a powerful tool for optimizing oncology drug dosage and improving benefit-risk profiles.
  • Addressing the challenges of MIDD is crucial for its effective implementation in oncology drug development.
  • This approach supports more efficient and effective drug development pathways.
Keywords:
MIDDProject Optimusdosage optimization

More Related Videos

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo09:19

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Published on: February 6, 2015

8.3K
Multiparametric Tumor Organoid Drug Screening Using Widefield Live-Cell Imaging for Bulk and Single-Organoid Analysis12:41

Multiparametric Tumor Organoid Drug Screening Using Widefield Live-Cell Imaging for Bulk and Single-Organoid Analysis

Published on: December 23, 2022

5.9K

Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
97
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
405
Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
10.4K
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
605
Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
366
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...
561