Evidence-Based Dose Optimization

True Dose is a spin-out from Karolinska Institutet in Stockholm, Sweden, bringing pioneering research in Therapeutic Drug Monitoring and precision medicine into clinical use. The research, Tailordose, started 2013 by Elham Hedayati together with Per Rydberg.

01

THERAPEUTIC DRUG MONITORING

Therapeutic Drug Monitoring (TDM) is a crucial yet often underutilized aspect of modern healthcare. Many healthcare providers and patients remain unaware of its benefits, resulting in missed opportunities for optimizing treatment outcomes. By understanding and leveraging TDM, we can significantly enhance patient care and safety.

  • TDM is essential for tailoring drug dosages to individual patient needs, maximizing therapeutic effects while minimizing side effects. This personalized approach is increasingly important in modern healthcare.

  • TDM ensures that drug levels remain within the therapeutic range, leading to better clinical outcomes, enhanced patient safety, and reduced incidence of adverse drug reactions, which are significant concerns in healthcare.

  • TDM is widely supported by clinical guidelines and regulatory bodies for various medications, reinforcing its critical role in healthcare. This endorsement underlines the reliability and necessity of TDM in medical practice.

  • By monitoring drug levels accurately, TDM significantly reduces the risk of toxicity and other adverse effects, ensuring a safer treatment process for patients.

  • Ongoing innovations in diagnostic technologies are making TDM more efficient and accessible. These advancements are paving the way for new applications and improved patient care in both clinical and home settings.

Publications 1 to 6

  1. Beumer JH. Without Therapeutic Drug Monitoring, There Is No Personalized Cancer Care. Clinical Pharmacology & Therapeutics. 2013 Mar;93(3):228–30.

  2. Groenland SL, van Eerden RAG, Westerdijk K, Meertens M, Koolen SLW, Moes DJAR, et al. Therapeutic drug monitoring-based precision dosing of oral targeted therapies in oncology: a prospective multicenter study☆. Annals of Oncology. 2022 Oct 1;33(10):1071–82.

  3. Lyashchenko AK, Cremers S. On precision dosing of oral small molecule drugs in oncology. British Journal of Clinical Pharmacology. 2020 Jul 17;87(2):263–70.

  4. Beumer JH, Chu E, Salamone SJ. All Optimal Dosing Roads Lead to Therapeutic Drug Monitoring – Why Take the Slow Lane. JAMA oncology. 2022 Dec 1;8(12):1733–5.

  5. Syversen SW, Jørgensen KK, Goll GL, Brun MK, Sandanger Ø, Bjørlykke KH, et al. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases. JAMA. 2021 Dec 21;326(23):2375.

  6. Meertens M, Giraud EL, van der Kleij MBA, Westerdijk K, Niels A D Guchelaar, Bleckman RF, et al. Evaluating the Clinical Impact and Feasibility of Therapeutic Drug Monitoring of Pazopanib in a Real-World Soft-Tissue Sarcoma Cohort. Clinical Pharmacokinetics. 2024 Jul 1;63(7):1045–54.

02

MICROSAMPLING

Microsampling is a powerful yet often underutilized technique in modern healthcare. Many healthcare providers and patients remain unaware of its benefits, resulting in missed opportunities for optimizing treatment outcomes. By understanding and leveraging microsampling, particularly in conjunction with TDM, we can significantly enhance patient care and safety.

  • Microsampling involves collecting small volumes of blood or other biological samples, reducing the discomfort and risk associated with traditional blood draws. This minimally invasive approach is especially beneficial for patients requiring frequent monitoring.

  • Due to its ease and convenience, microsampling encourages better patient adherence to monitoring schedules. This leads to more accurate and consistent data, which is crucial for effective TDM.

  • Microsampling can be performed in a variety of settings, including at home, making it more accessible to patients who may have difficulty visiting healthcare facilities frequently. This accessibility supports more widespread use of TDM.

  • By allowing for more frequent sampling, microsampling provides a richer data set for healthcare providers. This improves the precision of TDM, enabling more accurate adjustments to medication regimens.

  • Advances in microsampling technology are making it increasingly feasible to combine with TDM. These innovations are driving new applications and improving patient care by enabling real-time monitoring and more personalized treatment plans.

Publications 1 to 3

  1. Chen Z, Goudarzi CC, Sikorski TW, Weng N. Enhancing drug development and clinical studies with patient‐centric sampling using microsampling techniques: Opportunities, challenges, and insights into liquid chromatography‐mass spectrometry strategies. Journal of Mass Spectrometry. 2024 Apr 16;59(5).

  2. Mazzarino M, Al-Mohammed H, Sara Khalid Al-Darwish, Salama S, AlAnoud Al-Kaabi, Waseem Samsam, et al. Liquid vs dried blood matrices: Application to longitudinal monitoring of androstenedione, testosterone, and IGF-1 by LC-MS-based techniques. Journal of Pharmaceutical and Biomedical Analysis. 2024 May 1;242:116007–7.

  3. Maass KF, Barfield MD, Ito M, James CA, Kavetska O, Kozinn M, et al. Leveraging patient‐centric sampling for clinical drug development and decentralized clinical trials: Promise to reality. Clinical and Translational Science. 2022 Oct 8;15(12):2785–95.

03

HEALTH ECONOMY

The integration of TDM with microsampling presents significant economic advantages for the healthcare system. Despite its proven benefits, this innovative approach is not yet widely adopted, leading to missed opportunities for cost savings and improved efficiency. By embracing TDM with microsampling, healthcare providers can achieve substantial economic gains while enhancing patient care.

  • Implementing TDM with microsampling can significantly reduce hospital visits and associated healthcare costs by enabling more accurate and timely drug dosage adjustments, preventing costly adverse drug reactions and hospital readmissions.

  • Microsampling streamlines the sample collection process, reducing the need for specialized personnel and equipment, thus lowering operational costs and increasing the efficiency of healthcare services.

  • With more accurate and frequent drug monitoring, healthcare providers can allocate resources more effectively, prioritizing patients who need immediate intervention and optimizing the overall management of chronic conditions.

  • By ensuring drugs are used at their most effective doses, TDM with microsampling minimizes waste and maximizes the therapeutic value of medications, leading to better healthcare outcomes and cost-efficiency.

  • The convenience and reduced discomfort of microsampling encourages greater patient adherence to monitoring protocols, resulting in improved long-term health outcomes and reduced overall healthcare expenditures.

Publications 1 to 5

  1. Carland JE, Carland DJ, Brett J, Stocker SL, Roberts DM, Day RO, et al. Economic evaluations of therapeutic drug monitoring interventions in acute hospital‐based settings: A systematic review. British Journal of Clinical Pharmacology. 2024 Jul 10;242.

  2. C. Louwrens Braal, Kleijburg A, Jager A, Stijn L. W. Koolen, Mathijssen RHJ, Isaac Corro Ramos, et al. Therapeutic Drug Monitoring-Guided Adjuvant Tamoxifen Dosing in Patients with Early Breast Cancer: A Cost-Effectiveness Analysis from the Prospective TOTAM Trial. Clinical drug investigation. 2022 Jan 12;42(2):163–75.

  3. Erku D, Schneider J, Scuffham P. A framework for economic evaluation of therapeutic drug monitoring—guided dosing in oncology. Pharmacology Research & Perspectives. 2021 Sep 21;9(5).

  4. Vithanachchi DT, Annick Maujean, Downes M, Paul Anthony Scuffham. A comprehensive review of economic evaluations of therapeutic drug monitoring interventions for cancer treatments. British Journal of Clinical Pharmacology. 2021 Feb 1;87(2):271–83.

  5. M. van Nuland, Vreman RA, Ten Ham RMT, de Vries Schultink AHM, Rosing H, J. H. M. Schellens, et al. Cost-effectiveness of monitoring endoxifen levels in breast cancer patients adjuvantly treated with tamoxifen. Breast Cancer Research and Treatment. 2018 Jul 13;172(1):143–50.