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  • 1
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 81, No. 6 ( 2016-06), p. 1078-1090
    Abstract: To examine whether strict control of clinical trial conditions could reduce apparent differences of pharmacokinetic (PK) parameters among ethnic groups. Methods Open‐label, single dose PK studies of moxifloxacin, simvastatin and meloxicam were conducted in healthy male subjects from three East Asian populations ( Japanese , Chinese and Koreans) and one Caucasian population as a control. These three drugs were selected because differences in PK parameters have been reported, even though the backgrounds of these East Asian populations are similar. Moxifloxacin (400 mg) was administered orally to 20 subjects, and plasma and urine levels of moxifloxacin and its metabolite (M2) were measured. Simvastatin (20 mg) was given to 40 subjects, and plasma levels of simvastatin and simvastatin acid were measured. Meloxicam (7.5 mg) was given to 30 subjects and its plasma concentration was determined. Intrinsic factors (polymorphism of UGT1A1 for moxifloxacin, SLCO1B1 for simvastatin, and CYP2C9 for meloxicam) were also examined. Results AUC inf values for moxifloxacin, simvastatin and meloxicam showed no significant differences among the East Asian groups. C max values of moxifloxacin and simvastatin, but not meloxicam, showed significant differences. There were no significant differences of data for M2 or simvastatin acid. Genetic analysis identified significant differences in the frequencies of relevant polymorphisms, but these differences did not affect the PK parameters observed. Conclusions Although there were some differences in PK parameters among the three East Asian groups, the present study performed under strictly controlled conditions did not reproduce the major ethnic differences observed in previous studies.
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 2016
    detail.hit.zdb_id: 1498142-7
    SSG: 15,3
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  • 2
    In: Cancer Medicine, Wiley, Vol. 7, No. 6 ( 2018-06), p. 2269-2279
    Abstract: We conducted data mining using the US Food and Drug Administration ( FDA ) Adverse Event Reporting System ( FAERS ) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio ( ROR ) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular‐targeted drugs). We focused on molecular‐targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab‐containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology.
    Type of Medium: Online Resource
    ISSN: 2045-7634 , 2045-7634
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2659751-2
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  • 3
    In: Anti-Cancer Drugs, Ovid Technologies (Wolters Kluwer Health), Vol. 31, No. 2 ( 2020-02), p. 183-189
    Abstract: Tumor lysis syndrome (TLS) is a cancer chemotherapy-associated oncologic emergency. Although there have recently been substantial developments in cancer chemotherapy, these may increase the risk of TLS. In this study, we aimed to identify anticancer agents that increase TLS risk, as classified by a TLS panel consensus, using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. TLS reports were retrieved from the FAERS database, and reporting odds ratios (RORs) were used to estimate associations between TLS and old and new anticancer agents or their combinations. We identified 1615 TLS cases among 4 330 807 case reports covering the period from the first quarter of 2004 through to the first quarter of 2014. Using RORs, we detected significant risk signals for 56 of 64 anticancer agents (37 and 19 cytotoxic and molecular-targeted drugs, respectively). Bortezomib in particular was found to be associated with a high ROR and numerous TLS events relative to those of other molecular-targeted drugs (161 TLS events, ROR = 28.89, 95% confidence interval: 24.53–34.02). The main indication of bortezomib is multiple myeloma, a low-risk disease for TLS occurrence. We conducted a detailed analysis focusing on regimens containing bortezomib, lenalidomide, and thalidomide. Bortezomib-containing treatment regimens were more frequently associated with TLS events than were other multiple myeloma treatment regimens (cytotoxic chemotherapy, lenalidomide, and thalidomide). Although the risk of TLS in patients with multiple myeloma is generally considered low, a cautious evaluation of TLS risk is recommended for patients receiving bortezomib-containing therapy.
    Type of Medium: Online Resource
    ISSN: 0959-4973
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2025803-3
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  • 4
    In: Journal of Applied Toxicology, Wiley, Vol. 38, No. 2 ( 2018-02), p. 274-283
    Abstract: Regulatory T cells (Tregs) in the skin might be involved in the onset of severe cutaneous adverse drug reactions (SCARs). Allopurinol, a drug known to cause SCARs, was found to inhibit HaCaT cell expression of TARC/CCL17 and MDC/CCL22 , factors affecting Treg migration, and suppress Treg migration itself. These results suggest that the sparse distribution of Tregs in the skin following allopurinol treatment may induce SCARs.
    Type of Medium: Online Resource
    ISSN: 0260-437X , 1099-1263
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 1475015-6
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  • 5
    In: Pharmacoepidemiology and Drug Safety, Wiley, Vol. 23, No. 9 ( 2014-09), p. 984-988
    Abstract: Drug‐induced liver injury (DILI) is one of the primary targets for pharmacovigilance using medical information databases (MIDs). Because of diagnostic complexity, a standardized method for identifying DILI using MIDs has not yet been established. We applied the Digestive Disease Week Japan 2004 (DDW‐J) scale, a Japanese clinical diagnostic criteria for DILI, to a DILI detection algorithm, and compared it with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM) scale to confirm its consistency. Characteristics of DILI cases identified by the DDW‐J algorithm were examined in two Japanese MIDs. Methods Using an MID from the Hamamatsu University Hospital, we constructed a DILI detection algorithm on the basis of the DDW‐J scale. We then compared the findings between the DDW‐J and CIOMS/RUCAM scales. We examined the characteristics of DILI after antibiotic treatment in the Hamamatsu population and a second population that included data from 124 hospitals, which was derived from an MID from the Medical Data Vision Co., Ltd. We performed a multivariate logistic regression analysis to assess the possible DILI risk factors. Results The concordance rate was 79.4% between DILI patients identified by the DDW‐J and CIOMS/RUCAM; the Spearman rank correlation coefficient was 0.952 ( P   〈  0.0001). Men showed a significantly higher risk for DILI after antibiotic treatments in both MID populations. Conclusions The DDW‐J and CIOMS/RUCAM algorithms were equivalent for identifying the DILI cases, confirming the utility of our DILI detection method using MIDs. This study provides evidence supporting the use of MID analyses to improve pharmacovigilance. Copyright © 2014 John Wiley & Sons, Ltd.
    Type of Medium: Online Resource
    ISSN: 1053-8569 , 1099-1557
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2014
    detail.hit.zdb_id: 1491218-1
    SSG: 15,3
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  • 6
    Online Resource
    Online Resource
    Wiley ; 2021
    In:  Clinical Pharmacology & Therapeutics Vol. 109, No. 6 ( 2021-06), p. 1555-1563
    In: Clinical Pharmacology & Therapeutics, Wiley, Vol. 109, No. 6 ( 2021-06), p. 1555-1563
    Abstract: We identified the major points that are described in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline but have not been considered in the past multiregional clinical trials (MRCTs) used for drug approval in Japan to elucidate potential challenges in the implementation of the ICH E17 guideline in Japan. Based on the analysis of 167 MRCTs of 130 drugs, several points, such as the same dose setting and consistency between the overall and Japanese populations, in addition to good clinical practice compliance, have been well considered in ≥ 75% of MRCTs. In contrast, the use of relevant guidelines for disease and primary end point definitions, standardization of efficacy/safety information, sample size allocation, as well as training/validation on subject selection and primary end point, have been addressed less adequately and may need to be considered when planning future MRCTs. This study provides useful information for the implementation of the ICH E17 guideline in Japan.
    Type of Medium: Online Resource
    ISSN: 0009-9236 , 1532-6535
    URL: Issue
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2040184-X
    SSG: 15,3
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  • 7
    In: CPT: Pharmacometrics & Systems Pharmacology, Wiley, Vol. 6, No. 12 ( 2017-12), p. 823-832
    Abstract: We aimed to reanalyze the differences in the pharmacokinetics (PKs) of meloxicam in East Asian populations based on a population approach using previously published data and to investigate the factors found in population PK analysis that affect the pharmacodynamics (PDs) of meloxicam. Population PK analysis was performed in 119 healthy male subjects (30 Japanese, 30 Chinese, 29 Korean, and 30 white) under strictly controlled trial conditions with regulated meals and a single lot of the drug. We found that CYP2C9 genotype and lean body mass were statistically significant predictors of clearance and volume of distribution, respectively. A statistical significant difference in the PK parameters between ethnic groups could not be identified. Simulations using PK/PD models showed that CYP2C9 genotype is the factor that affects the PDs of meloxicam. The genetic polymorphisms highlighted in this study would be beneficial for conducting clinical trials in East Asians with similar genetic backgrounds.
    Type of Medium: Online Resource
    ISSN: 2163-8306 , 2163-8306
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2697010-7
    SSG: 15,3
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  • 8
    In: Andrology, Wiley, Vol. 10, No. 1 ( 2022-01), p. 166-178
    Abstract: Patients with cancer are treated with chemotherapeutics that cause adverse effects, including erectile dysfunction (ED). Objectives We investigated erectile function in rats after the administration of anticancer agents based on data retrieved through mining of the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database. Materials and methods The statistical signal strength for the association between anticancer drugs and ED was calculated using the reporting odds ratio (ROR). A drug–event combination was detected when the lower limit of the 95% confidence interval (CI) of the ROR exceeded 1.00. Rats were administered anticancer agents detected in the FDA AERS analysis. Erectile function was assessed using intracavernous pressure (ICP) and mean arterial pressure (MAP) analysis after electrical stimulation of the cavernous nerve. Statistical significance was determined using Welch's t ‐test or two‐way ANOVA. Results Melphalan (L‐PAM; ROR = 4.72, 95% CI = 2.78–8.00), vincristine (VCR; ROR = 2.47, 95% CI = 1.54–3.97), docetaxel (DTX; ROR = 2.25, 95% CI = 1.28–3.95), methotrexate (MTX; ROR = 1.96, 95% CI = 1.39–2.75), and doxorubicin (DOX; ROR = 1.82, 95% CI = 1.07–3.19) enhanced ED risk. L‐PAM and MTX decreased the ICP/MAP ratio 1 week after administration. VCR and DOX decreased erectile function 4 weeks after administration. DTX decreased erectile function at all assessed time points. Discussion and conclusion Certain anticancer agents should be considered risk factors for ED. Our results provide possible treatment strategies for maintaining erectile function in cancer survivors, including careful erectile function monitoring after treatment.
    Type of Medium: Online Resource
    ISSN: 2047-2919 , 2047-2927
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2693844-3
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  • 9
    Online Resource
    Online Resource
    Japanese Pharmacological Society ; 2016
    In:  Folia Pharmacologica Japonica Vol. 148, No. 1 ( 2016), p. 18-21
    In: Folia Pharmacologica Japonica, Japanese Pharmacological Society, Vol. 148, No. 1 ( 2016), p. 18-21
    Type of Medium: Online Resource
    ISSN: 0015-5691 , 1347-8397
    Uniform Title: 医薬品のグローバル開発におけるレギュラトリーサインスの役割
    Language: English , Japanese
    Publisher: Japanese Pharmacological Society
    Publication Date: 2016
    detail.hit.zdb_id: 2143155-3
    SSG: 15,3
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  • 10
    In: FEBS Letters, Wiley, Vol. 260, No. 2 ( 1990-01-29), p. 179-182
    Abstract: A wasp venom, mastoparan, rapidly increased the cytosolic free Ca 2+ concentration ([Ca 2+ ] i ) and activated phosphorylase in rat hepatocytes in a concentration‐dependent manner. Mastoparan could increase [Ca 2+ ] i even in the absence of extracellular Ca 2+ , but a larger increase was observed in the presence of extracellular Ca 2+ . Thus, mastoparan mobilized Ca 2+ from intracellular and extracellular Ca 2+ stores. It also activated inositol triphosphate (IP 3 ) accumulation, but did not stimulate cAMP production. From these results, we conclude that mastoparan activates rat hepatic glycogenolysis mediated by the accumulation of IP 3 , which causes an increase of [Ca 2+ ] i but not that mediated by cAMP.
    Type of Medium: Online Resource
    ISSN: 0014-5793 , 1873-3468
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 1990
    detail.hit.zdb_id: 1460391-3
    SSG: 12
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