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Related Concept Videos

Dose Size and Dosing Frequency: Determination Methods01:21

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Determining the optimal dose size and dosing frequency in pharmacotherapy is crucial for achieving therapeutic effectiveness while minimizing adverse effects. This article explores the methodologies employed in determining these parameters, focusing on their significance and interplay to tailor dosing regimens.Dose Size: Dose size refers to the amount of a drug administered in a single dose. It is determined based on the drug's pharmacodynamics and pharmacokinetics properties and...
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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Dosage Regimens: Partial Pharmacokinetic Parameters01:01

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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...
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Dosage Regimen: Individualization01:24

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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...
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Dosage Regimens: Designs and Approaches01:28

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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...
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Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

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Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
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Updated: Dec 23, 2025

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
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A dose-finding approach for genomic patterns in phase I trials.

S Kaneko1, A Hirakawa2, Y Kakurai3,4

  • 1Japan Development, Biostatistics Pharma, Integrated Biostatistics Japan, Novartis Pharma K.K ., Minato-ku, Tokyo, Japan.

Journal of Biopharmaceutical Statistics
|April 21, 2020
PubMed
Summary

This study introduces a new method for finding the best dose of cancer drugs in early trials. It simultaneously determines the optimal dose and relevant genes for precision medicine.

Keywords:
Oncologydose-findinggenomic mutation patternphase Iprecision medicine

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Area of Science:

  • Oncology
  • Genomics
  • Pharmacology

Background:

  • Precision medicine tailors treatment to individual variability in genes, environment, and lifestyle.
  • Cancer's genomic nature necessitates understanding how mutations affect drug response.
  • Individualized optimal drug doses, balancing efficacy and safety, are crucial for precision cancer therapy.

Purpose of the Study:

  • To propose a novel dose-finding algorithm for identifying individualized optimal doses of molecularly targeted agents in Phase I cancer trials.
  • To simultaneously determine optimal drug dosage and identify influential genes for precision medicine applications.
  • To enhance early-phase drug development by integrating genomic data into dose selection.

Main Methods:

  • Developed a novel dose-finding approach using L1 and L2 penalized regression for simultaneous dose and gene selection.
  • Modeled non-monotonic dose-efficacy and dose-toxicity relationships, accounting for outcome correlations using multinomial distribution.
  • Utilized a predictive probability algorithm based on estimated penalized regression models for dose determination.

Main Results:

  • The proposed method enables simultaneous determination of individualized optimal doses and identification of relevant genes.
  • The algorithm effectively handles complex dose-response relationships and outcome correlations.
  • Simulation studies demonstrated the operating characteristics of the novel approach compared to existing methods.

Conclusions:

  • The novel dose-finding approach is effective for identifying individualized optimal doses in precision oncology.
  • Simultaneous gene selection and dose determination are feasible and beneficial for early-phase cancer trials.
  • This method advances precision medicine by optimizing drug selection and dosing based on individual genomic profiles.