Author(s):
Saloni Vaibhav Koli, Madhuri Bhushan Patil
Email(s):
salonnikolli9@gmail.com
DOI:
10.52711/0974-360X.2026.00408
Address:
Saloni Vaibhav Koli1*, Madhuri Bhushan Patil2
1Department of Pharmacy Practice, Krishna Institute of Pharmacy, Krishna Vishwa Vidyapeeth (Deemed to Be University), Karad, Maharashtra – 415539, India.
2Department of Pharmaceutics, Krishna Institute of Pharmacy, Krishna Vishwa Vidyapeeth (Deemed to Be University), Karad, Maharashtra – 415539, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 6,
Year - 2026
ABSTRACT:
Therapeutic Drug Monitoring (TDM) is a cornerstone of precision pharmacotherapy aimed at optimising drug efficacy while minimising toxicity. A thorough review of TDM in clinical practice is given in this review, with a focus on its use in the management of drugs with limited therapeutic indices, including immunosuppressant’s (cyclosporine, tacrolimus), cardiovascular agents (digoxin), psychiatric drugs (lithium), and antiepileptic’s (phenytoin, valproic acid, carbamazepine, and lamotrigine). We searched the literature for peer-reviewed studies published between 2000 and 2025 using PubMed, Scopus, Web of Science, and Google Scholar. Assay methods, therapeutic and hazardous ranges, important pharmacokinetic parameters, and monitoring plans were retrieved and examined. The integration of pharmacogenomics (e.g., CYP2C9 and CYP3A5 polymorphisms), its applicability in special populations (paediatrics, geriatrics, pregnancy, and critically ill), and recent developments in point-of-care diagnostics and AI-driven dosing platforms are some of the other emerging trends in TDM that are highlighted in this review. TDM lowers hospitalisations, enhances therapeutic results, and helps provide patient care at a reasonable cost. The advancement of TDM implementation in standard clinical settings depends on the creation of standardised guidelines, the application of contemporary biosensors, and the integration of genetic profiling.
Cite this article:
Saloni Vaibhav Koli, Madhuri Bhushan Patil. Therapeutic Drug Monitoring: Enhancing Drug Safety and Efficacy in Clinical Practice. Research Journal Pharmacy and Technology. 2026;19(6):2859-8. doi: 10.52711/0974-360X.2026.00408
Cite(Electronic):
Saloni Vaibhav Koli, Madhuri Bhushan Patil. Therapeutic Drug Monitoring: Enhancing Drug Safety and Efficacy in Clinical Practice. Research Journal Pharmacy and Technology. 2026;19(6):2859-8. doi: 10.52711/0974-360X.2026.00408 Available on: https://rjptonline.org/AbstractView.aspx?PID=2026-19-6-65
REFERENCES:
1. Ghiculescu RA. Therapeutic drug monitoring: which drugs, why, when and how to do it. Aust Prescr. 2008; 31(2): 42–4.
2. Lee ZN, van Nuland M, Bognàr T, Leijten FSS, van der Elst KCM. Association of lamotrigine plasma concentrations with efficacy and toxicity in patients with epilepsy: A retrospective study. Clin Ther. 2022; 44(6): 1011–23. doi:10.1016/j.clinthera.2022.03.011.
3. Ali AS, Rahman AF, Hmed MS. Basic principles of therapeutic drug monitoring. J Pharm Biomed Sci. 2021; 12(2): 67–78.
4. Chong E, Dupuis LL. Therapeutic drug monitoring of lamotrigine: An evaluation of routine monitoring of serum concentrations. Ann Pharmacother. 2002; 36(6): 917–20.
5. Syahputra RA, Harahap U, Dalimunthe A, Nasution MP, Satria D. Drug therapy monitoring (TDM) of digoxin: Safety and efficacy review. J Pharm Sci Res. 2023; 15(4): 112–9.
6. Abdi Syahputra R, Harahap U, Dalimunthe A, Nasution MP, Satria D. Drug therapy monitoring (TDM) of digoxin: safety and efficacy review. Pharmacia. 2022; 69(2): 261–4. doi:10.3897/pharmacia.69.e81467.
7. Ooba N, Tsutsumi D, Kobayashi N, Hidaka S, Hayashi H, Obara T, et al. Prevalence of therapeutic drug monitoring for lithium and the impact of regulatory warnings: analysis using the Japanese claims database. Ther Drug Monit. 2018; 40(2): 252–6. doi:10.1097/FTD.0000000000000483.
8. Sharma S, Joshi S, Chadda RK. Therapeutic drug monitoring of lithium in patients with bipolar affective disorder: experiences from a tertiary care hospital in India. Am J Ther. 2009; 16(5): 393–7. doi:10.1097/MJT.0b013e31818a88da.
9. von Winckelmann SL, Spriet I, Willems L. Therapeutic drug monitoring of phenytoin in critically ill patients. Pharmacotherapy. 2008; 28(11): 1391–400. doi:10.1592/phco.28.11.1391.
10. Ates HC, Roberts JA, Lipman J, Cass AEG, Urban GA, Dincer C. On-site therapeutic drug monitoring: A review of advancements in point-of-care drug analysis. Biosens Bioelectron. 2023; 217: 114763. doi:10.1016/j.bios.2023.114763.
11. Costa B, Silva I, Oliveira JC, Reguengo H, Vale N. Pharmacokinetic simulation study: Exploring the impact of clinical parameters on lamotrigine for different patient populations with implications for liver function assessment and therapeutic drug monitoring. Sci Pharm. 2024; 92(1): 15. doi:10.3390/scipharm92010015.
12. Märtson AG, Sturkenboom MGG, Stojanova J, Cattaneo D, Hope W, Marriott D, et al. How to design a study to evaluate therapeutic drug monitoring in infectious diseases? Clin Microbiol Infect. 2020; 26(8): 1008–16. doi:10.1016/j.cmi.2020.03.008.
13. Takahashi N, Kondo Y, Kubo K, Egi M, Kano K, Ohshima Y, et al. Efficacy of therapeutic drug monitoring-based antibiotic regimen in critically ill patients: A systematic review and meta-analysis of randomised controlled trials. J Intensive Care. 2023; 11: 48. doi:10.1186/s40560-023-00689-4.
14. Tsyvunin V, Shtrygol S, Mishchenko M, Ryzhenko I, Shtrygol D, Oklei D. Low-dose digoxin is associated with anticonvulsant effect enhancement of classical antiepileptic drugs in the electro-induced seizures in mice. Res J Pharm Technol. 2022; 15(9): 4241–7. doi:10.52711/0974-360X.2022.00713.
15. Khandelwal R, Vagha JD, Meshram RJ, Patel A. A comprehensive review on unveiling the journey of digoxin: past, present, and future perspectives. Cureus. 2024; 16(3): e56755. doi:10.7759/cureus 56755.
16. Paruthi P, Pansare G, Khairnar A. Use of triggers to detect adverse drug reaction induced by cardiovascular drugs in the outpatient department in Nasik city. Res J Pharm Technol. 2011; 4(12): 1819–21.
17. Safdar A, Ismail F. A comprehensive review on pharmacological applications and drug-induced toxicity of valproic acid. Saudi Pharm J. 2023; 31(2): 265–78. doi:10.1016/j.jsps.2022.12.001.
18. Porter RJ, Dhir A, Macdonald RL, Rogawski MA. Mechanisms of action of antiseizure drugs. Handb Clin Neurol. 2012; 108: 663–81. doi:10.1016/B978-0-444-52899-5.00021-6.
19. Costa B, Silva I, Oliveira JC, Reguengo H, Vale N. Pharmacokinetic simulation study: exploring the impact of clinical parameters on lamotrigine for different patient populations with implications for liver function assessment and therapeutic drug monitoring. Sci Pharm. 2024; 92(1): 15. doi:10.3390/scipharm92010015.
20. Sawant RL, Bhatia MS. Application of Topliss Modified Approach in the design and synthesis of GABA-nergic anticonvulsants. Res J Pharm Technol. 2008; 1(3): 273–5.
21. Grześk G, Stolarek W, Kasprzak M, Grześk E, Rogowicz D, Wiciński M, et al. Therapeutic drug monitoring of carbamazepine: A 20-year observational study. J Clin Med. 2021; 10(22): 5396. doi:10.3390/jcm10225396.
22. Grześk G, Stolarek W, Kasprzak M, Grześk E, Rogowicz D, Wiciński M, et al. Therapeutic drug monitoring of carbamazepine: A 20-year observational study. J Clin Med. 2021; 10(22): 5396. doi:10.3390/jcm10225396.
23. Ningrum DVA, Sukemi P, Rhidohan KA, Yuniarti E. A study of carbamazepine utilisation in the hospitals in Yogyakarta Special Province. Res J Pharm Technol. 2022; 15(6): 2577–84. doi:10.52711/0974-360X.2022.00431.
24. Alda M. Lithium in the treatment of bipolar disorder: Pharmacology and pharmacogenetics. Mol Psychiatry. 2015; 20(6): 661–70. doi:10.1038/mp 2015.4.
25. Menaka K, Sarumathy S, Sivakumar T. Study on the adverse reactions of antipsychotics and therapeutic drug monitoring of olanzapine in psychiatric patients. Res J Pharm Technol. 2016; 9(6): 687–90. doi:10.5958/0974-360X.2016.00128.1.
26. Kumar SB. Role of caffeine in dementia, Alzheimer’s, Parkinsonism, and bipolar mood disorder. Res J Pharm Technol. 2015; 8(11): 1582–7.
27. Arora P, Ranawat MS, Arora N. Synthesis and screening of some novel coumarin derivatives for antipsychotic activity. Res J Pharm Technol. 2012; 5(7): 968–72.
28. Kong Q, Gao N, Wang Y, Hu G, Qian J, Chen B. Functional evaluation of cyclosporine metabolism by CYP3A4 variants and potential drug interactions. Front Pharmacol. 2023; 13: 1044817. doi:10.3389/fphar.2022.1044817.
29. Sarumathy S, George PSG, Kumar BYP, Mukundan VA, Shanmugarajan TS, Maheshwari P. Clinical comparison of serum lipids between cyclosporine and tacrolimus treated renal transplant recipients. Res J Pharm Technol. 2016; 9(6): 694–8. doi:10.5958/0974-360X.2016.00130.
30. Chehade A, Rao J. Topical calcineurin inhibitors. In: Wolverton SE, editor. Comprehensive Dermatologic Drug Therapy. 4th ed. Philadelphia: Elsevier; 2021. p. 549–56.e5. doi:10.1016/B978-0-323-61211-1.00048-6.
31. Yu M, Liu M, Zhang W, Ming Y. Pharmacokinetics, pharmacodynamics, and pharmacogenetics of tacrolimus in kidney transplantation. Curr Drug Metab. 2018; 19(6): 513–22. doi:10.2174/1389200219666180129151948.
32. Inselman AL, Hansen DK. Phenytoin. In: Wexler P, editor. Encyclopedia of Toxicology. 3rd ed. New York: Academic Press; 2014. p. 895–7. doi:10.1016/B978-0-12-386454-3.00771-5.
33. Islamiyah WR, Suharjono, Jaya HP, Ernawati I. Analysis relationship of self-medication card administration with adherence (ARMS score), phenytoin serum levels and frequency of seizures in patients using phenytoin monotherapy. Res J Pharm Technol. 2019; 12(12): 5991–6000. doi:10.5958/0974-360X.2019.010.
34. Kim YJ, Suh YT. Effect of psychomotor program on self-esteem and cognitive ability of the elderly women. Res. J Pharm. Technol. 2017; 10(7): 2274–8.
35. Ghiculescu RA. Therapeutic drug monitoring: which drugs, why, when and how to do it. Aust Prescr. 2008; 31(2): 42–4