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  • 1
    Online Resource
    Online Resource
    Pharmacokinetics of Temozolomide in a Patient With Glioblastoma Undergoing Hemodialysis: A Short Communication
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Therapeutic Drug Monitoring ( 2023-8-15)
    Details
    In: Therapeutic Drug Monitoring, Ovid Technologies (Wolters Kluwer Health), ( 2023-8-15)
    Abstract: Temozolomide (TMZ) is an alkylating agent used to treat glioblastoma. However, the pharmacokinetics of TMZ to establish a treatment strategy for patients undergoing hemodialysis (HD) remain unclear. In this case report, we evaluated the pharmacokinetics and HD removal rate of TMZ in a patient with glioblastoma undergoing HD to determine optimal dosing of TMZ. Methods: A 78-year-old man with glioblastoma who underwent HD 3 times a week was treated with TMZ concomitant with radiotherapy. One dose of TMZ was prescribed at 75 mg/m 2 on the day before HD and another dose of 37.5 mg/m 2 on the day before non-HD. Peak and trough concentrations (1 hour and 12 hours after dosing, respectively) were evaluated before HD and on non-HD days. HD removal rate of TMZ was calculated based on the predialyzer and postdialyzer plasma concentrations. Furthermore, the TMZ plasma concentrations were measured using liquid chromatography–tandem mass spectrometry. Results: The mean plasma peak and trough concentrations ± SD after 75 mg/m 2 TMZ were 2917 ± 914 and 108 ± 17.6 ng/mL, respectively. Those after 37.5 mg/m 2 TMZ dosage were 1305 ± 650 and 53.8 ± 11.8 ng/mL, respectively. The mean HD TMZ removal rate was 84.9 ± 1.9%. Conclusions: TMZ was tolerable in patients undergoing HD. Based on the data from a single individual pharmacokinetic perspective, the pharmacokinetics of TMZ in this patient undergoing HD were comparable with those observed in patients with normal renal function. In addition, it may be reasonable to administer TMZ after HD because of the high HD removal rate.
    Type of Medium: Online Resource
    ISSN: 0163-4356
    URL: Article
    DOI: 10.1097/FTD.0000000000001125
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2048919-5
    SSG: 15,3
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  • 2
    Online Resource
    Online Resource
    Population pharmacokinetics and exposure–clinical outcome relationship of remdesivir major metabolite GS ‐441524 in patients with moderate and severe COVID ‐19
    Wiley ; 2023
    In:  CPT: Pharmacometrics & Systems Pharmacology Vol. 12, No. 4 ( 2023-04), p. 513-521
    Details
    In: CPT: Pharmacometrics & Systems Pharmacology, Wiley, Vol. 12, No. 4 ( 2023-04), p. 513-521
    Abstract: Although remdesivir, a prodrug of nucleoside analog (GS‐441524), has demonstrated clinical benefits in coronavirus disease 2019 (COVID‐19) treatment, its pharmacokinetics (PKs) in patients with COVID‐19 remain poorly understood. Therefore, in this study, the PKs of remdesivir and its major metabolite, GS‐441524, were evaluated using a population PK (PopPK) approach to understand the PK aspect and exposure–clinical outcome relationship. The serum concentrations of remdesivir and GS‐441524 (102 points in 39 patients) were measured using liquid chromatography–tandem mass spectrometry. All patients received 200 mg remdesivir on the first day, followed by 100 mg on 2–5 days, except for one patient who discontinued remdesivir on day 4. The median (range) age, body surface area, and estimated glomerular filtration rate (eGFR) were 70 (42–85), 1.74 m 2 (1.36–2.03), and 68 mL/min/1.73 m 2 (33–113), respectively. A compartment model with first‐order elimination combined with remdesivir and GS‐441524 was used for nonlinear mixed‐effects model analysis. Remdesivir was rapidly eliminated after infusion, whereas GS‐441524 was eliminated relatively slowly (half‐time = 17.1 h). The estimated apparent clearance (CL) and distribution volume of GS‐441524 were 11.0 L/h (intersubject variability [ISV]% = 43.0%) and 271 L (ISV% = 58.1%), respectively. The CL of GS‐441524 was significantly related to the eGFR (CL × [eGFR/68] 0.745 ). The post hoc area under the curve of GS‐441524 was unrelated to the recovery rate or aspartate aminotransferase/alanine aminotransferase elevation. Overall, PopPK analysis showed the rapid elimination of remdesivir in the blood, and GS‐441524 accumulation depended on eGFR in patients with COVID‐19. However, no relevance of exposure–clinical outcome was not suggestive of the dose adjustment of remdesivir.
    Type of Medium: Online Resource
    ISSN: 2163-8306 , 2163-8306
    URL: Issue
    URL: Article
    DOI: 10.1002/psp4.v12.4
    DOI: 10.1002/psp4.12936
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2697010-7
    SSG: 15,3
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  • 3
    Online Resource
    Online Resource
    Survey on Practical Training in Community Pharmacies and Hospital Pharmacies
    Japanese Society of Pharmaceutical Health Care and Sciences ; 2006
    In:  Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) Vol. 32, No. 1 ( 2006), p. 64-72
    Details
    In: Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences), Japanese Society of Pharmaceutical Health Care and Sciences, Vol. 32, No. 1 ( 2006), p. 64-72
    Type of Medium: Online Resource
    ISSN: 1882-1499 , 1346-342X
    Uniform Title: 保険薬局および病院・診療所における学生実務実習の実態調査
    URL: Article
    DOI: 10.5649/jjphcs.32.64
    Language: Japanese
    Publisher: Japanese Society of Pharmaceutical Health Care and Sciences
    Publication Date: 2006
    SSG: 15,3
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  • 4
    Online Resource
    Online Resource
    Population pharmacokinetics of favipiravir in patients with COVID‐19
    Wiley ; 2021
    In:  CPT: Pharmacometrics & Systems Pharmacology Vol. 10, No. 10 ( 2021-10), p. 1161-1170
    Details
    In: CPT: Pharmacometrics & Systems Pharmacology, Wiley, Vol. 10, No. 10 ( 2021-10), p. 1161-1170
    Abstract: The antiretroviral drug favipiravir (FPV) inhibits RNA‐dependent RNA polymerase. It has been developed for the treatment of the novel coronavirus (severe acute respiratory syndrome coronavirus 2) infection disease, coronavirus disease 2019 (COVID‐19). However, its pharmacokinetics in patients with COVID‐19 is poorly understood. In this study, we measured FPV serum concentration by liquid chromatography–tandem mass spectrometry and conducted population pharmacokinetic analysis. A total of 39 patients were enrolled in the study: 33 were administered FPV 1600 mg twice daily (b.i.d.) on the first day followed by 600 mg b.i.d., and 6 were administered FPV 1800 mg b.i.d. on the first day followed by 800 mg or 600 mg b.i.d. The median age was 68 years (range, 27–89 years), 31 (79.5%) patients were men, median body surface area (BSA) was 1.72 m 2 (range, 1.11–2.2 m 2 ), and 10 (25.6%) patients required invasive mechanical ventilation (IMV) at the start of FPV. A total of 204 serum concentrations were available for pharmacokinetic analysis. A one‐compartment model with first‐order elimination was used to describe the pharmacokinetics. The estimated mean clearance/bioavailability (CL/F) and distribution volume/bioavailability (V/F) were 5.11 L/h and 41.6 L, respectively. Covariate analysis revealed that CL/F was significantly related to dosage, IMV use, and BSA. A simulation study showed that the 1600 mg/600 mg b.i.d. regimen was insufficient for the treatment of COVID‐19 targeting the 50% effective concentration (9.7 µg/mL), especially in patients with larger BSA and/or IMV. A higher FPV dosage is required for COVID‐19, but dose‐dependent nonlinear pharmacokinetics may cause an unexpected significant pharmacokinetic change and drug toxicity. Further studies are warranted to explore the optimal FPV regimen.
    Type of Medium: Online Resource
    ISSN: 2163-8306 , 2163-8306
    URL: Issue
    URL: Article
    DOI: 10.1002/psp4.v10.10
    DOI: 10.1002/psp4.12685
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2697010-7
    SSG: 15,3
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  • 5
    Online Resource
    Online Resource
    Population Pharmacokinetics of Nivolumab in Japanese Patients with Nonsmall Cell Lung Cancer
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Therapeutic Drug Monitoring Vol. 45, No. 1 ( 2023-02), p. 110-116
    Details
    In: Therapeutic Drug Monitoring, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 1 ( 2023-02), p. 110-116
    Abstract: Nivolumab is an antiprogrammed death-1 (PD-1) antibody used for immuno-oncological therapy of various cancers, including nonsmall cell lung cancer (NSCLC). This study aimed to characterize the real-world population pharmacokinetics (PK) of nivolumab in patients with NSCLC. Methods: PK samples were collected by opportunistic sampling of Japanese patients with NSCLC treated with nivolumab monotherapy. Population PK analysis was performed using a two-compartment model in Nonlinear Mixed Effect Model. Patient-specific factors such as body weight, age, sex, serum albumin, estimated glomerular filtration rate, performance status, programmed cell death receptor ligand 1 expression in tumors, and treatment periods were evaluated as potential covariates for clearance. Results: A total of 223 serum samples collected from 34 patients were available for analysis. The median (min–max) age and weight were 69 years (38–83 years) and 62.7 kg (36.8–80.5 kg), respectively. The mean (95% confidence interval) clearance estimate was 0.0064 L/h (0.0058–0.0070 L/h). The inclusion of the ALB level, estimated glomerular filtration rate, and treatment period significantly improved the model fit. Conclusions: A real-world nivolumab population PK model was developed using an opportunistic sampling strategy in Japanese patients with NSCLC. Further studies are warranted to characterize the exposure–response relationship and determine the optimal dosing regimens for these patients.
    Type of Medium: Online Resource
    ISSN: 0163-4356
    URL: Article
    DOI: 10.1097/FTD.0000000000000996
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2048919-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
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