---
title: "Optimal Limited Sampling for Busulfan TDM in Adults and Adolescents Undergoing Allogeneic HSCT"
id: "pubmed-42678294"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42678294"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42678294/"
doi: "10.1002/jcph.70281"
published_at: "2026-09-01T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Optimal Limited Sampling for Busulfan TDM in Adults and Adolescents Undergoing Allogeneic HSCT
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42678294
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42678294/)
- **DOI:** [10.1002/jcph.70281](https://doi.org/10.1002%2Fjcph.70281)
- **Published At:** 2026-09-01T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- Busulfan has a **narrow therapeutic index** and high pharmacokinetic variability, so therapeutic drug monitoring (**TDM**) is used to achieve target exposure in hematopoietic stem cell transplantation (HSCT). - There is no consensus on an optimal limited sampling strategy (**LSS**) for once-daily (QD) intravenous busulfan prior to this analysis. - The study used Monte Carlo simulation to generate a virtual adult cohort (n = 1000) receiving once-daily IV busulfan 3.2 mg/kg as a 3-hour infusion, informed by three published population pharmacokinetic models. - Individual PK parameters were estimated from Day‑1 one- and two-sample LSS designs using maximum a posteriori Bayesian estimation; these estimates were used to predict the 4-day cumulative area under the concentration-time curve (AUC). - A model-informed precision-dosing (**MIPD**) analysis quantified the benefit of TDM and dose adjustment guided by each LSS design in terms of cumulative target attainment. - Across all three population PK models, a two-sample **early-plus-late** LSS was most informative; the recommended two-sample schedule was samples at **3 and 7 hours** after infusion start. - TDM guided by a well-chosen two-sample LSS approximately **doubled cumulative target attainment** compared with no TDM; a single early 3-hour sample performed markedly worse. - In an external validation cohort (n = 37) of adults and adolescents, two-sample designs recovered the 4-day cumulative AUC with median absolute percentage error (MAPE) of approximately **5%–8%**, versus **11%–13%** for a single 3-hour sample. - As a simpler alternative, a single 6-hour sample provided performance inferior to the two-sample schedule but better than a single 3-hour sample. - The study supports a two-sample LSS at 3 and 7 hours for QD intravenous busulfan in adults and adolescents to inform MIPD and improve dosing decisions and target attainment.
## Clinical Analysis & Structured Key Points
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Affiliations Expand ### Affiliations * 1 Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands. * 2 Division of Systems Pharmacology and Pharmacy, Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands. * 3 Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands. * 4 Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands. * 5 Department of Hospital Pharmacy, Rotterdam Erasmus Medical Center, Rotterdam, The Netherlands. * PMID: **42678294** * DOI: [ 10.1002/jcph.70281 ](https://doi.org/10.1002/jcph.70281) Item in Clipboard # Simulation-Based Evaluation of Busulfan Sampling Strategies in Adults and Adolescents Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Zhiyuan Tan et al. J Clin Pharmacol. 2026 Sep. Show details Display options Display options Format Abstract PubMed PMID J Clin Pharmacol Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22J+Clin+Pharmacol%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22J+Clin+Pharmacol%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) . 2026 Sep;66(9):e70281. doi: 10.1002/jcph.70281. ### Authors [Zhiyuan Tan](https://pubmed.ncbi.nlm.nih.gov/?term=Tan+Z&cauthor_id=42678294)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-1 "Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-2 "Division of Systems Pharmacology and Pharmacy, Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands."), [Federica R Achini-Gutzwiller](https://pubmed.ncbi.nlm.nih.gov/?term=Achini-Gutzwiller+FR&cauthor_id=42678294)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-3 "Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands."), [Arjan C Lankester](https://pubmed.ncbi.nlm.nih.gov/?term=Lankester+AC&cauthor_id=42678294)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-3 "Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands."), [Joost G K van der Hem](https://pubmed.ncbi.nlm.nih.gov/?term=van+der+Hem+JGK&cauthor_id=42678294)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-4 "Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands."), [Peter A von dem Borne](https://pubmed.ncbi.nlm.nih.gov/?term=von+dem+Borne+PA&cauthor_id=42678294)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-4 "Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands."), [Dirk Jan A R Moes](https://pubmed.ncbi.nlm.nih.gov/?term=Moes+DJAR&cauthor_id=42678294)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-1 "Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands."), [Tim Preijers](https://pubmed.ncbi.nlm.nih.gov/?term=Preijers+T&cauthor_id=42678294)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42678294/#short-view-affiliation-5 "Department of Hospital Pharmacy, Rotterdam Erasmus Medical Center, Rotterdam, The Netherlands.") ### Affiliations * 1 Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands. * 2 Division of Systems Pharmacology and Pharmacy, Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands. * 3 Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands. * 4 Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands. * 5 Department of Hospital Pharmacy, Rotterdam Erasmus Medical Center, Rotterdam, The Netherlands. * PMID: **42678294** * DOI: [ 10.1002/jcph.70281 ](https://doi.org/10.1002/jcph.70281) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract Busulfan, used in hematopoietic stem cell transplantation, exhibits a narrow therapeutic index and high pharmacokinetic (PK) variability. Therapeutic drug monitoring (TDM) is currently employed to achieve target exposure. However, there is no consensus on an optimal limited sampling strategy (LSS) for busulfan on the once-daily (QD) regimen. A virtual cohort of adult patients (n = 1000) receiving OD intravenous busulfan 3.2 mg/kg as a 3-h infusion was generated by Monte Carlo simulation using three published busulfan population PK models. For each one- and two-sample LSS, individual PK parameters were estimated from Day-1 sample(s) by maximum a posteriori Bayesian estimation and used to estimate the 4-day cumulative AUC. A model-informed precision-dosing (MIPD) analysis quantified the target-attainment benefit of TDM per design. The best-performing designs were validated in an external cohort (n = 37) with adults and adolescents. Across all three models, a two-sample early-plus-late schedule was the most informative, and the recommended two-sample design was 3 and 7 h after the start of infusion. TDM guided by a well-chosen LSS approximately doubled cumulative-target attainment, whereas a single early 3-h sample was markedly weaker. In the external cohort, two-sample designs recovered the cumulative 4-day AUC to ∼5%-8% MAPE versus ∼11%-13% for a single 3-h sample. For OD intravenous busulfan in adults and adolescents, a two-sample schedule at 3 and 7 h after the start of infusion supports the correct dosing decision and, through MIPD-guided dose adjustment, approximately doubles target attainment; a single 6-h sample is a simpler but less robust alternative. **Keywords:** busulfan; hematopoietic stem cell transplantation; limited sampling strategy; model‐informed precision dosing; optimal design. © 2026 The Author(s). The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## References 1. 1. Santos GW, Tutschka PJ, Brookmeyer R, et al. Marrow transplantation for acute nonlymphocytic leukemia after treatment with busulfan and cyclophosphamide. N Engl J Med. 1983;309(22):1347‐1353. doi:10.1056/nejm198312013092202 2. 1. Ciurea SO, Andersson BS. Busulfan in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2009;15(5):523‐536. doi:10.1016/j.bbmt.2008.12.489 3. 1. Singhal S, Kim T, Jenkins P, Bassett B, Tierney DK, Rezvani AR. Costs and outcomes with once‐daily versus every‐6‐hour intravenous busulfan in allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2020;26(1):145‐149. doi:10.1016/j.bbmt.2019.09.008 4. 1. Clemmons AB, Evans S, DeRemer DL, Awan FT. Busulfan dosing (Q6 or Q24) with adjusted or actual body weight, does it matter? J Oncol Pharm Pract. 2015;21(6):425‐432. doi:10.1177/1078155214541571 5. 1. Marsit H, Philippe M, Neely M, et al. Intra‐individual pharmacokinetic variability of intravenous busulfan in hematopoietic stem cell‐transplanted children. Clin Pharmacokinet. 2020;59(8):1049‐1061. doi:10.1007/s40262‐020‐00877‐z Show all 25 references ## MeSH terms * Adolescent Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Adolescent%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Adolescent) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Adult Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Adult%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Adult) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Area Under Curve Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Area+Under+Curve%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Area+Under+Curve) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Bayes Theorem Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Bayes+Theorem%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Bayes+Theorem) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Busulfan* / administration & dosage Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Busulfan%2Fadministration+and+dosage%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Busulfan) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Busulfan* / blood Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Busulfan%2Fblood%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Busulfan) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Busulfan* / pharmacokinetics Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Busulfan%2Fpharmacokinetics%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Busulfan) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Computer Simulation Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Computer+Simulation%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Computer+Simulation) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Drug Monitoring* / methods Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Drug+Monitoring%2Fmethods%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Drug+Monitoring) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Female Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Female%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Female) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Hematopoietic Stem Cell Transplantation* / methods Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Hematopoietic+Stem+Cell+Transplantation%2Fmethods%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Hematopoietic+Stem+Cell+Transplantation) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Humans Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Humans%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Humans) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Immunosuppressive Agents* / administration & dosage Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Immunosuppressive+Agents%2Fadministration+and+dosage%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Immunosuppressive+Agents) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Immunosuppressive Agents* / pharmacokinetics Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Immunosuppressive+Agents%2Fpharmacokinetics%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Immunosuppressive+Agents) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42678294/) * Male Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Male%22%5BMeSH%5D&sort=date&s
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