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Clinical Pharmacology

Master's Program Human Sciences, Graduate School of Medicine
Doctor's Program Medical Science Division, Department of Medical Science, Graduate School of Medicine, Science and Technology

Staff List

Professor NAITO Takafumi
Research Assistant KAMIJO Shinobu

Contact

E-mail : naitou(at)shinshu-u.ac.jp
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Summary of Activity

Our department creates the drug information for implementing the rational pharmacotherapy in clinical settings. For the goal, we develop the quantitative methods of drugs in human biological samples using a liquid chromatograph coupled to mass spectrometer. The present projects quantitatively evaluate the inter-individual variations in clinical responses to drugs from the viewpoints of pharmacokinetics and pharmacodynamics. We finally aim to construct the rational pharmacotherapy based on the factors related to the clinical responses to drugs for each disease and its condition. Our recent attempts are to detect the unknown adverse events and drug-drug interactions using non-experimental methods.

Research Subject

  • ・Development of quantitative methods of drugs in human biological samples
  • ・Evaluation of inter-individual variations in clinical responses to drugs
  • ・Construction of rational pharmacotherapy for the disease and its conditions
  • ・Detection of unknown adverse events and drug-drug interactions using non-experimental methods

Outlook for Research

Development of quantitative methods of drugs in human biological samples
We develop the quantitative methods of drugs in human biological samples using an ultra-high performance liquid chromatography and liquid chromatography coupled to mass spectrometer. Our methods are validated to apply to clinical samples according to international guidance. Our department recently puts effort into the development of rapid quantitation of biomedicines including antibody drug in human serum.

Evaluation of inter-individual variation in clinical responses to drugs
Our researches aim to identify determinants/factors that can be used in day-to-day practice to support treatment decisions. We attempt the evaluations of patient data on factors related to the pharmacokinetics, drug efficacy, and adverse reactions observed in clinical settings. Our department recently puts effort into the evaluation of inter-individual variation in clinical responses to drugs at inflammatory conditions and during the perinatal period.

Construction of rational pharmacotherapy for the disease and its conditions
Our researches focus on optimizing pharmacotherapy and pharmaceutical care to the individual patient. Clarification of patient factors related to the pharmacokinetics, drug efficacy, and adverse reactions leads to the construction of rational pharmacotherapy. We aim to construct the rational pharmacotherapy for the disease and its conditions.

Detection of unknown adverse events and drug-drug interactions using non-experimental methods
We aim to detect the unknown adverse events and drug-drug interactions using non-experimental methods. For the goal, our department uses the medical information system in Shinshu University Hospital and the Japanese Adverse Drug Event Report Database. Our pharmacoepidemiological studies using non-experimental methods potentially contribute to the promotion of appropriate and safety use of pharmaceutical products.

Major Publications

1. Shibata K, Naito T, Hirakawa S, Suzuki K, Hosokawa S, Mineta H, Kawakami J (2021) Correlations between serum cetuximab and EGFR-related markers, and skin disorders in head and neck cancer patients. Cancer Chemother Pharmacol. 87(4): 555-565.

2. Imoto Y, Naito T, Miyadera Y, Ono T, Kawakami J (2021) Associations between plasma hydroxylated metabolite of itraconazole and serum creatinine in patients with a hematopoietic or immune-related disorder. Eur J Clin Pharmacol. 77(3): 369-379.

3. Suzuki K, Naito T, Tanaka H, Shibata K, Yamada Y, Itoh K, Kawakami J (2021) Impact of CYP2D6 activity and cachexia progression on enantiomeric alteration of plasma tramadol and its demethylated metabolites and their relationships with central nervous system symptoms in head and neck cancer patients. Basic Clin Pharmacol Toxicol. 128(3): 472-481.

4. Yagi T, Naito T, Kato A, Hirao K, Kawakami J (2021) Association between the prothrombin time-international normalized ratio and concomitant use of antibiotics in warfarin users: Focus on type of antibiotic and its susceptibility to Bacteroides fragilis. Ann Pharmacother. 55(2): 157-164.

5. Hoshikawa K, Naito T, Akutsu S, Saotome M, Maekawa Y, Kawakami J (2020) Impact of CYP3A5 genotype on tolvaptan pharmacokinetics and their relationships with endogenous markers of CYP3A activity and serum sodium level in heart failure patients. Basic Clin Pharmacol Toxicol. 126(4): 353-363.

6. Abe K, Shibata K, Naito T, Karayama M, Hamada E, Maekawa M, Yamada Y, Suda T, Kawakami J (2020) Quantitative LC-MS/MS method for nivolumab in human serum using IgG purification and immobilized tryptic digestion. Anal Methods. 12: 54-62.

7. Taguchi R, Naito T, Kubono N, Ogawa N, Itoh H, Kawakami J (2019) Relationships between endogenous CYP3A markers and plasma amlodipine exposure and metabolism in early postpartum and non-peripartum women with hypertension. Pregnancy Hypertens. 17: 209-215.

8. Yoshikawa N, Naito T, Yagi T, Kawakami J (2019) Impact of cachexia and opioid analgesic co-treatment on pregabalin pharmacokinetics and central nervous system symptoms in cancer patients. Ther Drug Monit. 41(5): 591-597.

9. Naito T, Ohshiro J, Sato H, Torikai E, Suzuki M, Ogawa N, Kawakami J (2019) Relationships between concomitant biologic DMARDs and prednisolone administration and blood tacrolimus exposure or serum CYP3A4/5-related markers in rheumatoid arthritis patients. Clin Biochem. 69: 8-14.

10. Shida H, Naito T, Shibata K, Yamada Y, Kawakami J (2018) LC-MS/MS method for denosumab quantitation in human serum with rapid protein digestion using immobilized trypsin. Bioanalysis. 10(18): 1501-1510.

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