Active 沙巴体育 Initiatives
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Pharmacometric Model Development of Sunitinib and Recommendation of Dosing Nomograms
■???? The aim of this study is to develop a pharmacometrics model and dosing nomogram for sunitinib in renal cell carcinoma patients
■???? Principal Investigator: Dr. Surulivel Rajan M
■???? Co-Investigator: Ms. Heta Shah
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Clinical Assessment of Pharmacometric model guided dosing in oncology
■???? The aim of the study was to develop a population pharmacokinetics model for Imatinib and Tamoxifen in chronic myeloid leukemia and breast cancer patients using a pharmacometric approach.
■???? Principal Investigator: Dr. Surulivel Rajan M
■???? Co-Investigator: Dr. Jaya Shree Dilli Batcha
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Pharmacometric and Pharmacogenomic Integration for Precision Dosing of Tacrolimus
■???? The study aims to assess the impact of CYP3A5 polymorphism, develop a population pharmacokinetic model, and recommend an optimal Tacrolimus dosage regimen.
■???? Principal Investigator: Dr. Surulivel Rajan M
■???? Co-Investigator: Dr. Arun Prasath
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Precision therapy of Gefitinib in Non-Small Cell lung Cancer Patients: An Integrated Pharmacogenomic and Population Pharmacokinetic Approach
■???? Objectives of the study include carrying out the pharmacogenomic screening and pharmacokinetic analysis of gefitinib in NSCLC patients and to develop a population pharmacokinetic model for gefitinib in the studied population.
■???? Principal Investigator: Dr. Mahadev Rao
■???? Co-Investigators: Dr. Surulivel Rajan M & Ms. Prathvi Shenoy
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Integrating Pharmacogenomic and Population Pharmacokinetic Analysis for Precision Therapy of Isoniazid in TB Patients.
■???? The current study aims to explore the use of NAT2 polymorphisms among TB patients for developing an isoniazid population pharmacokinetic (PopPK) model and potential dosage individualization plan
■???? Principal Investigator: Dr. Mahadev Rao
■???? Co-Investigators: Dr. Surulivel Rajan M & Mr. Levin Thomas M
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Population pharmacodynamic model of Morphine and Tapentadol in palliative oncology
■???? The current study aims to develop pharmacodynamic models that can potentially help in dosage optimisation? decisions in palliative oncology patients.??
■???? Principal Investigator: Dr. Rajesh V
■???? Co-Investigators: Dr. Surulivel Rajan M & Mr. Elstin Anburaj
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Where Modeling Drives Discoveries
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○???? Clinical Pharmacometrics : Application of Pharmacometrics in the bedside for assisting in? precision pharmacotherapy. We conduct clinical pharmacokinetics studies to collect pharmacokinetic data in patient- population that includes special populations like neonates, renal transplant patients and oncology patients. The data will be analyzed using appropriate pharmacometric methods to derive the pharmacokinetic parameters and nomograms. These nomograms can aid in precise dosing as per the requirements of patients.
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○???? Model informed drug development : Clinical pharmacology based decisions drive the drug development pathways and pharmacometrics is an important tool in clinical pharmacology that can be helpful in driving the progression of drug development. Pharmacometrics can also be applied in the drug development stages spanning from the preclinical to clinical stages.
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Training and mentoring : Centre focuses on developing the talent base needed for clinical pharmacology and pharmacometrics. Centre runs certificate courses, offering fellowships in pharmacometrics and conducting workshops on relevant focus areas of drug development and clinical pharmacometrics. Centre envisages for the conduct of national conferences in the area of drug development and pharmacometrics.?
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Our Contributions to the Field
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List of publications
○???? Garg, K., Bhandari, R.K., Shafiq, N. et al. Population pharmacokinetics of ciprofloxacin in newborns with early onset neonatal sepsis and suspected meningitis. Pediatr Res (2023). https://doi.org/10.1038/s41390-023-02941-3.
○???? Matcha, S., Dillibatcha, J., Raju, A.P. et al. Predictive Performance of Population Pharmacokinetic Models for Amikacin in Term Neonates. Pediatr Drugs 25, 365–375 (2023). https://doi.org/10.1007/s40272-023-00564-z
○???? Dilli Batcha, J.S.; Raju, A.P.; Matcha, S.; Raj S., E.A.; Udupa, K.S.; Gota, V.; Mallayasamy, S. Factors Influencing Pharmacokinetics of Tamoxifen in Breast Cancer Patients: A Systematic Review of Population Pharmacokinetic Models. Biology 2023, 12, 51. https://doi.org/10.3390/biology12010051
○???? Raj JP, Gogtay NJ, Pandey A, Kakkar AK, Shafiq N, Mekala P, Pingali U, Raju AP, Mallayasamy S, Kshirsagar NA. Population Pharmacokinetics of Hydroxychloroquine Sulfate in Healthcare Workers, Given for Prophylaxis Against Coronavirus Disease 2019 (COVID-19) in India. J Clin Pharmacol. 2022 Nov;62(11):1403-1411. doi: 10.1002/jcph.2092. Epub 2022 Jun 30. PMID: 35656997; PMCID: PMC9347612.
○???? Thomas, L., Raju, A.P., Chaithra et al. Influence of N-acetyltransferase 2 (NAT2) genotype/single nucleotide polymorphisms on clearance of isoniazid in tuberculosis patients: a systematic review of population pharmacokinetic models. Eur J Clin Pharmacol 78, 1535–1553 (2022). https://doi.org/10.1007/s00228-022-03362-7.
○???? Farhan M, Rani P, Moledina F, George T, Tummala HP, Mallayasamy S. Application of Physiologically Based Pharmacokinetic Modeling of Lamotrigine Using PK-Sim in Predicting the Impact of Drug Interactions and Dosage Adjustment. Journal of Pharmacology and Pharmacotherapeutics. 2022;13(2):160-166. doi:10.1177/0976500X221111455
○???? Kaibara A, Peng A, Xie R, Ho YF, Lin CJ, Tham LS, Mallayasamy S, Sathirakul K, Lo YL, Tran MH, Pham VT, Kharis Nugroho A, Myo Oo K, Kunwar B, Mannapperuma U, Ya K, Usman M, Ming LC, Park K. The Asian Pharmacometrics Network: The historical background, establishment, objectives and roles, and recent activities. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):403-408. doi: 10.1002/psp4.12777. Epub 2022 Mar 14. PMID: 35286775; PMCID: PMC9007605.
○???? Kalluru H, Mallayasamy SR, Kondaveeti SS, Chandrasekhar V, Kalachaveedu M. Effect of turmeric supplementation on the pharmacokinetics of paclitaxel in breast cancer patients: A study with population pharmacokinetics approach. Phytotherapy 沙巴体育 : PTR. 2022 Apr;36(4):1761-1769. DOI: 10.1002/ptr.7412. PMID: 35181963.
○???? Tummala HP, Balusu R, Thotakura S, et al. Development of Physiologically Based Pharmacokinetic Model and Assessment of the Impact of Renal Underdevelopment in Preterm Infants on the Pharmacokinetics of Aminophylline. Journal of Pharmacology and Pharmacotherapeutics. 2022;13(1):72-78. doi:10.1177/0976500X221080209
○???? Matcha, S., Raj, E.A., Mahadevan, R. et al. Pharmacometric approach to assist dosage regimen design in neonates undergoing therapeutic hypothermia. Pediatr Res 92, 249–254 (2022). https://doi.org/10.1038/s41390-021-01714-0
○???? Sridharan K, Ansari EA, Mulubwa M, Raju AP, Madhoob AA, Jufairi MA, Hubail Z, Marzooq RA, Hasan SJR, Mallaysamy S. Population pharmacokinetic-pharmacodynamic modeling of acetaminophen in preterm neonates with hemodynamically significant patent ductus arteriosus. Eur J Pharm Sci. 2021 Dec 1;167:106023. doi: 10.1016/j.ejps.2021.106023. Epub 2021 Sep 28. PMID: 34592463.
○???? Sridharan K, Sannala CKR, Mallayasamy S, Chaturvedula A, Kadam P, Hase N, Shukla A, Gogtay N, Thatte U. Population pharmacokinetics of primaquine and the effect of hepatic and renal dysfunction: An exploratory approach. Indian J Pharmacol. 2019 Jan-Feb;51(1):17-24. doi: 10.4103/ijp.IJP_230_16. PMID: 31031463; PMCID: PMC6444836.
○???? Mallaysamy, S., Johnson, M.G., Rao, P.G.M. et al. Population pharmacokinetics of lamotrigine in Indian epileptic patients. Eur J Clin Pharmacol 69, 43–52 (2013). https://doi.org/10.1007/s00228-012-1311-9