ReviewJournal of pharmacokinetics and pharmacodynamics2023
A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.
Review in Journal of pharmacokinetics and pharmacodynamics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed, 40 citations in OpenAlex.
- Population Pharmacokinetics and Exposure-Response Analyses of Savolitinib Alone or in Combination With Osimertinib in Patients With Locally Advanced or Metastatic Solid Tumors.Clinical and translational science · 2026Trial
- Exposure-Response Analyses of Datopotamab Deruxtecan (Dato-DXd), a TROP2-Directed Antibody-Drug Conjugate, in Advanced Non-small Cell Lung Cancer.Clinical pharmacology and therapeutics · 2026Article
- The 95% CDIRAs, a Credible Interval Based Method to Capture Uncertainty in Population Modeling: Pharmacokinetics Versus Sum of Exponentials Case Study.CPT: pharmacometrics & systems pharmacology · 2026Article
- Clinical innovations and future directions of nanoparticles in the treatment of psychiatric and neurological disorders.Molecular psychiatry · 2026Review
- Article
- Precision in Pharmacoeconomics: A Comparative Cost-Utility Analysis of Osimertinib in EGFR-Mutant NSCLC Using Traditional and Pharmacometric Models.Therapeutic innovation & regulatory science · 2026Article
- Follow-Up Bias in Tumor Dynamic Modeling: A Comparison of Classical and Neural-ODE Approaches.CPT: pharmacometrics & systems pharmacology · 2026Article
- Longitudinal Tumor Size and Survival Modeling for Exposure-Response Analysis of Drugs with Frequent Dose Reductions: Dose Justification of Abemaciclib in Patients with Metastatic Breast Cancer.Clinical pharmacology and therapeutics · 2026Article
- Applications of Pharmacometrics in Antibody-Drug Conjugate Development.Pharmaceutics · 2026Review
- Can evolutionary therapy be applied in non-small cell lung cancer?Scientific reports · 2026Article
- RNA therapeutic targeting of recalcitrant and rare cancers.Exploration of targeted anti-tumor therapy · 2026Review
- Exposure-Response Analysis for Time-to-Event Data in the Presence of Adaptive Dosing: Efficient Approaches and Pitfalls.CPT: pharmacometrics & systems pharmacology · 2026Article
- Exposure-response relationship of sintilimab in advanced gastric cancer: insights from time-dependent pharmacokinetics and biomarker integration for precision immunotherapy.Frontiers in pharmacology · 2026Review
- Oleanolic acid and its derivatives in breast cancer therapy: mechanistic insights, structural modifications, and novel delivery strategies.Frontiers in pharmacology · 2026Review
- Exposure-Response Analysis of Repotrectinib to Support the Dose Recommendation for Patients With ROS1-Positive NSCLC or NTRK-Positive Solid Tumors.CPT: pharmacometrics & systems pharmacology · 2025Article
- Evaluation and Mitigation of Time-Dependent Confounding Effects in Conventional Exposure-Response Analyses for Oncology Drugs.CPT: pharmacometrics & systems pharmacology · 2025Article
- FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Population Pharmacokinetics of Valemetostat and Exposure-Response Analyses of Efficacy and Safety in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma.Journal of clinical pharmacology · 2025Article
- Practical Pharmacokinetic-Pharmacodynamic Models in Oncology.Pharmaceutics · 2025Review
- Use of PopPK and E-R Analyses toward Explaining Causal Link Between ADAMTS13 in Recombinant vs. Plasma-Based Therapies and Clinical Effects in cTTP.Clinical pharmacology and therapeutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 11 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Exposure-response (E-R) analyses are an integral component in the development of oncology products. Characterizing the relationship between drug exposure metrics and response allows the sponsor to use modeling and simulation to address both internal and external drug development questions (e.g., optimal dose, frequency of administration, dose adjustments for special populations). This white paper is the output of an industry-government collaboration among scientists with broad experience in E-R modeling as part of regulatory submissions. The goal of this white paper is to provide guidance on what the preferred methods for E-R analysis in oncology clinical drug development are and what metrics of exposure should be considered.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.