174 results match your criteria japan's drug

Validation of measurement scores for evaluating vascular anomaly skin lesions.

J Dermatol 2021 Mar 30. Epub 2021 Mar 30.

Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan.

Vascular anomalies comprise a heterogeneous group of disorders caused by abnormal proliferation or development of vascular and/or lymphatic vessels. Vascular anomalies present with various symptoms and complications, but no standardized methods evaluate their severity, and to measure treatment outcomes is difficult. To assess the responsiveness of measurement scores for evaluating vascular anomaly skin lesions, we conducted a validation study to compare these measurement scores with patients' objective data. Read More

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The safety of ritodrine hydrochloride: Adverse effects on fetuses and newborns.

Drug Discov Ther 2021 03 27;15(1):14-19. Epub 2021 Feb 27.

Department of Pharmaceutical Sciences, Teikyo Heisei University, Nakano, Tokyo, Japan.

Prematurely born infants face unique risks, and the treatment of imminent preterm birth is thus an important part of perinatal care. Ritodrine hydrochloride (Rito) is widely used as a therapeutic agent to treat imminent preterm birth in Japan. Following assessment of the risks and benefits of short-acting β-agonists, including Rito, in Europe, however, the use of Rito has begun to be questioned. Read More

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Long-term sublingual immunotherapy provides better effects for patients with Japanese cedar pollinosis.

Auris Nasus Larynx 2021 Aug 29;48(4):646-652. Epub 2021 Jan 29.

Department of Otorhinolaryngology, Kansai Medical University, shinmachi 2-5-1, Hirakata, Osaka, Japan.

Objective: Japanese cedar pollinosis is an endemic disease affecting a large proportion of Japan's population. Five seasons have passed since sublingual immunotherapy (SLIT) for Japanese cedar pollinosis was included in the public insurance coverage in Japan. In this study, we evaluated the clinical effects of long-term SLIT for Japanese cedar pollinosis on upper respiratory symptoms primarily represented by nasal symptoms and inflammation of the respiratory tract in the 2019 season, in which considerable amount of cedar pollen was dispersed. Read More

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Medical costs of lung cancer care in Japan during the first one or two years after initial diagnosis.

Jpn J Clin Oncol 2021 Apr;51(5):778-785

Department of Medical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.

Objectives: Japan's healthcare expenditures, especially on oncology, are rapidly growing; however, there are scant data on actual costs and cost-effectiveness in the real world. The aim was to assess the medical costs and outcomes of patients with advanced lung cancer.

Methods: We retrospectively investigated all patients who were diagnosed with advanced lung cancer at the Japanese Red Cross Medical Center between 1 January 2008 and 31 December 2018. Read More

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Trend and treatment outcomes of latent tuberculosis infection among migrant persons in Japan: retrospective analysis of Japan tuberculosis surveillance data.

BMC Infect Dis 2021 Jan 9;21(1):42. Epub 2021 Jan 9.

Department of Epidemiology and Clinical Research, The Research Institute of Tuberculosis, 3-1-24, Matsuyama Kiyose, Tokyo, Japan.

Background: Screening for latent tuberculosis infection (LTBI) among migrant population has become a critical issue for many low tuberculosis (TB) burden countries. Evidence regarding effectiveness of LTBI programs are limited, however, partly because of paucity of national data on treatment outcomes for LTBI. In Japan, notification of LTBI is mandatory, and its treatment outcome is reported as part of Japan's national TB surveillance system. Read More

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January 2021

The effects of Japan's National Action Plan on Antimicrobial Resistance on antimicrobial use.

Int J Infect Dis 2021 Feb 20;103:154-156. Epub 2020 Nov 20.

AMR Clinical Reference Center, Disease Control and Prevention Center, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan; Collaborative Chairs Emerging and Reemerging Infectious Diseases, National Center for Global Health and Medicine, Graduate School of Medicine, 1-1, Seriryo-tyo, Aoba-ku, Sendai, Miyagi, Japan; Disease Control and Prevention Center, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan. Electronic address:

The aim of this study was to estimate the effects of Japan's National Action Plan on Antimicrobial Resistance 2016-2020 (NAP) on antimicrobial use (AMU). Monthly AMU from January 2013 to December 2019 was calculated using sales data, and time-series charts of AMU were then created for the total antimicrobials and target drug categories shown in the NAP (oral cephalosporins, oral fluoroquinolones, oral macrolides, and parenteral antimicrobials). Twelve-month predictions were generated to evaluate AMU in 2020. Read More

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February 2021

Japan's innovation for global health - GHIT's catalytic role.

Kei Katsuno

Parasitol Int 2021 Feb 2;80:102232. Epub 2020 Nov 2.

Investment Strategy & Business Development, GHIT Fund, 1-10-9, Roppongi, Minato-ku, Tokyo, Japan. Electronic address:

The global fight against infectious diseases, both emerging and re-emerging, endures. Japan's commitments and reputation as a good global citizen and its responsibility to uphold domestic and international human security mean that it is in Japan's best interest to leverage its innovative and technological capabilities for global infectious disease prevention and control. The Global Health Innovative Technology Fund (GHIT Fund), an international non-profit organization based in Tokyo, Japan, was established by the Japanese government, multiple Japanese pharmaceutical companies, and the Bill & Melinda Gates Foundation as the first fund of its kind, with an aim to tackle the global burden of infectious diseases by facilitating and funding global health R&D of drugs, vaccines, and diagnostics. Read More

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February 2021

[Expanding Pharmacy Services for Sustainable Universal Health Coverage: Lessons from the Canadian Health Care System].

Yakugaku Zasshi 2020 ;140(11):1365-1372

Faculty of Pharmacy, Keio University.

Japan's health care system can be regarded as one of the best worldwide, provided it remains sustainable. It has relatively low costs, short wait times, low disease incidence, and high life expectancy. However, universal coverage in Japan faces financial challenges due to the country's rapidly aging population. Read More

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November 2020

Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan.

Ther Innov Regul Sci 2021 03 11;55(2):304-308. Epub 2020 Sep 11.

Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, 565-0871, Japan.

Japan's rapidly aging population has prompted a change in the country's pharmaceutical care framework from a drug-oriented to a patient-oriented approach. Pharmacies and pharmacists are expected to play central roles in this new patient-oriented approach by reconciling medication and managing polypharmacy, conducting home visits, and providing care to patients in collaboration with local clinics and hospitals. These additional roles are expected to lead to a reduction in the prevalence of adverse effects and improve the quality of life of patients in Japan's aging society. Read More

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[Medical expenses for diabetes care in Japan: Analysis of inter-prefecture differences].

Nihon Koshu Eisei Zasshi 2020 ;67(8):501-508

Center for Next Generation of Community Health, Chiba University Hospital.

Objectives Medical expenses for diabetes differ between Japan's 47 prefectures. The medical care expenditure regulation plan aims to reduce regional differences in outpatient medical costs through prevention of severe diabetes, promotion of specific health checkups and specific health guidance, promotion of generic drugs, and proper use of medicines. To achieve this goal, we need to conduct an in-depth analysis of inter-prefecture differences in diabetes care expenses. Read More

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September 2020

Effectiveness of Social Measures against COVID-19 Outbreaks in Selected Japanese Regions Analyzed by System Dynamic Modeling.

Int J Environ Res Public Health 2020 08 27;17(17). Epub 2020 Aug 27.

Graduate School of Technology Management, Ritsumeikan University, Osaka 567-8570, Japan.

In Japan's response to the coronavirus disease 2019 (COVID-19), virus testing was limited to symptomatic patients due to limited capacity, resulting in uncertainty regarding the spread of infection and the appropriateness of countermeasures. System dynamic modelling, comprised of stock flow and infection modelling, was used to describe regional population dynamics and estimate assumed region-specific transmission rates. The estimated regional transmission rates were then mapped against actual patient data throughout the course of the interventions. Read More

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Contribution of Katsura-uri (Japan's Heirloom Pickling Melon, Cucumis melo var. conomon) at the Completely Ripe Stage to Diabetes Control.

J Nutr Sci Vitaminol (Tokyo) 2020 ;66(3):261-269

Graduate School of Life and Environmental Sciences, Kyoto Prefectural University.

The fruit of Katsura-uri (Japan's heirloom pickling melon, Cucumis melo var. conomon) possesses a fruity aroma and moderate sweetness. The fruit juice has potential to minimize human postprandial blood glucose levels. Read More

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Japan's Drug Regulation Framework: Aiming for Better Health or Bigger Profits?

Int J Health Policy Manag 2021 Jan 1;10(1):47-48. Epub 2021 Jan 1.

Medical Governance Research Institute, Tokyo, Japan.

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January 2021

A retrospective study of 2 or 3 mg/kg/day propranolol for infantile hemangioma.

Pediatr Int 2020 06 3;62(6):751-753. Epub 2020 Jun 3.

Department of Pediatrics, Gifu University Graduate School of Medicine, Gifu University, Gifu, Japan.

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Pharmaceuticals and Medical Device Agency approval summary: Amenamevir for the treatment of herpes zoster.

J Dermatol 2020 Jul 18;47(7):683-688. Epub 2020 May 18.

Office of New Drug IV, Pharmaceuticals and Medical Device Agency, Tokyo, Japan.

In July 2017, Japan's Ministry of Health, Labor and Welfare issued a marketing authorization valid throughout Japan for N-(2,6-dimethylphenyl)-N-(2-{[4-(1,2,4-oxadiazol-3-yl)phenyl]amino}-2-oxoethyl)-1,1-dioxothiane-4-carboxamide (amenamevir) for the first time worldwide. The decision was based on the favorable opinion of the Pharmaceuticals and Medical Device Agency (PMDA) recommending a marketing authorization of amenamevir for treatment of herpes zoster (HZ). Amenamevir has a different action mechanism from previously approved synthetic nucleoside compounds for the treatment of HZ including acyclovir, valacyclovir and famciclovir. Read More

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Use of Real-world Data for New Drug Applications and Line Extensions.

Clin Ther 2020 05 25;42(5):926-938. Epub 2020 Apr 25.

Department of Research and Development, Sanofi, Chilly-Mazarin, France. Electronic address:

Purpose: For this article, the authors compiled, summarized, and analyzed data from 27 cases in which real-world data (RWD) were applied in regulatory approval. The aims were to provide an overview of RWD, based on classifications per therapeutic area, age group, drivers of acceptability, utility, data sources, and timelines, and to present insights on how it has been applied in regulatory decision making to date.

Methods: Clarivate Analytics was commissioned to collect data from cases in which RWD was used for new drug applications and line extensions submitted to the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Health Canada, and Japan's Pharmaceuticals and Medical Devices Agency. Read More

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The controversy on HPV vaccination in Japan: Criticism of the ethical validity of the arguments for the suspension of the proactive recommendation.

Health Policy 2020 02 26;124(2):199-204. Epub 2019 Dec 26.

Department of Medical Ethics, Tohoku University Graduate School of Medicine, Sendai, Japan.

The Human Papillomavirus (HPV) vaccine was integrated into Japan's national immunization program (NIP) in April 2013. However, numerous instances of serious adverse reactions were widely reported in the media, resulting in the Ministry of Health, Labor, and Welfare (MHLW) suspending the official recommendation of the HPV vaccine on June 14, 2013. Investigating the reported incidents, the Vaccine Adverse Reactions Review Committee (VARRC)-an MHLW advisory committee-found no high-quality evidence supporting a causal relationship between the reported events and the HPV vaccination. Read More

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February 2020

Indications and classes of outpatient antibiotic prescriptions in Japan: A descriptive study using the national database of electronic health insurance claims, 2012-2015.

Int J Infect Dis 2020 Feb 13;91:1-8. Epub 2019 Nov 13.

Division of General Internal Medicine, Jichi Medical University Hospital, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, Japan; Division of Infectious Diseases, Jichi Medical University Hospital, 3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, Japan. Electronic address:

Objectives: To evaluate condition-specific antibiotic prescription rates and the appropriateness of antibiotic use in outpatient settings in Japan.

Methods: Using Japan's national administrative claims database, all outpatient visits with infectious disease diagnoses were linked to reimbursed oral antibiotic prescriptions. Prescription rates stratified by age, sex, prefecture, and antibiotic category were determined for each infectious disease diagnosis. Read More

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February 2020

A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study.

BMJ Open 2019 11 2;9(11):e032955. Epub 2019 Nov 2.

Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.

Introduction: One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. Read More

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November 2019

Japan's high-cost medical expense benefit system could be an obstacle to promoting generic imatinib.

Lancet Haematol 2019 10;6(10):e498

Department of Drug Discovery and Biochemical Sciences, Department of Internal Medicine, Faculty of Medicine Saga University, Saga 849-8501, Japan; Division of Hematology, Respiratory Medicine, and Oncology, Department of Internal Medicine, Faculty of Medicine Saga University, Saga 849-8501, Japan.

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October 2019

An impact analysis of the implementation of health technology assessment for new treatment of orphan diseases in Japan.

Expert Rev Pharmacoecon Outcomes Res 2020 Oct 25;20(5):455-471. Epub 2019 Sep 25.

Graduate School of Medicine, International University of Health and Welfare , Tokyo, Japan.

: In Japan, a cost-effectiveness evaluation (CEE) for pricing was introduced in April 2019 and potentially covers orphan drugs (ODs) within its scope. The purpose of this study was to explore a reasonable approach to evaluate the utility of health technology assessment (HTA) for ODs in Japan. : We extracted ODs that were approved in Japan from 2009 to 2018, and investigated their appraisals in the United Kingdom, Canada, and Australia, where HTA and different frameworks on ODs have been implemented. Read More

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October 2020

Factors affecting the provision of analgesia during childbirth, Japan.

Bull World Health Organ 2019 Sep 17;97(9):631-636. Epub 2019 Jul 17.

Kitasato University, Tokyo, Japan.

Japan's universal health-care system means that it is a very safe country in which to give birth. Perinatal outcomes in Japan are excellent, with low infant mortality and neonatal mortality. However, childbirth remains a challenge for many Japanese women, who are faced with a scarcity of places to give birth, limited availability of analgesia and social norms that favour natural birth. Read More

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September 2019

Comparing treatment intensification and clinical outcomes of metformin and dipeptidyl peptidase-4 inhibitors in treatment-naïve patients with type 2 diabetes in Japan.

J Diabetes Investig 2020 Jan 21;11(1):96-100. Epub 2019 Jun 21.

Pharmacy Practice and Science I, Research and Education Center for Clinical Pharmacy, Kitasato University School of Pharmacy, Sagamihara, Kanagawa, Japan.

Japan's guidelines emphasize tailored therapy, but do not guide physicians on the use of a specific regimen in drug-naive patients. The role of long-term initial therapy could be important in key elements of diabetes treatment, such as continuation of the initially prescribed drug. We investigated the frequency of occurrence to treatment intensification after the initiation of metformin or dipeptidyl peptidase-4 inhibitor treatment. Read More

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January 2020

[Forensic Science and Scientific Investigation].

Hiroyuki Inoue

Yakugaku Zasshi 2019 ;139(5):685-691

Third Department of Forensic Science, National Research Institute of Police Science.

The precise proof of a crime using objective evidence is becoming increasingly important as Japan's crime rate climbs. This need arises not only from the current high rate of anonymous crime, but also the introduction of a Saiban-in (citizen judge) system, and the increased silence of suspects following investigation visualization. Forensic science is an academic field that investigates legal (and illegal) matters using science, and subsequently applies research results to resolving real crime cases. Read More

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The utilization and challenges of Japan's MID-NET medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies.

Pharmacoepidemiol Drug Saf 2019 05 3;28(5):601-608. Epub 2019 Apr 3.

Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.

Purpose: To examine the potential role of Medical Information Database Network (MID-NET ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies.

Methods: The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. Read More

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Promotion of Japan's participation in global clinical trials.

Drug Discov Today 2019 04 30;24(4):939-942. Epub 2019 Jan 30.

Kowa Research Europe Ltd, 105 Wharfedale Road, Winnersh Triangle, Wokingham, UK.

The number of global clinical trials including Japan is increasing but still much lower than those including the USA and Europe. The regulatory requirements for clinical trials have been harmonized among Japan, USA, and Europe, and the quality of clinical trials is kept high in these regions. Xofluza (baloxavir marboxil) for influenza approved in Japan under the SAKIGAKE Designation System is a good example of clinical trials including Japan. Read More

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Colon capsule endoscopy and its effectiveness in the diagnosis and management of colorectal neoplastic lesions.

Expert Rev Anticancer Ther 2019 01 30;19(1):71-80. Epub 2018 Oct 30.

a Digestive Endoscopy Unit and Gastroenterology , Fondazione Poliambulanza , Brescia , Italy.

: Colorectal cancer (CRC) represents a major cause of morbidity and mortality in Western countries. Though colonoscopy is the benchmark for CRC diagnosis and management, other alternatives have been proposed. Colon capsule endoscopy (CCE) was first introduced in 2006 as a non-invasive painless technology that utilizes an ingestible, wireless, and disposable capsule to explore the colon, without sedation or air insufflation. Read More

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January 2019

Pharmacokinetics and Pharmacodynamics of the BACE1 Inhibitor Verubecestat (MK-8931) in Healthy Japanese Adults: A Randomized, Placebo-Controlled Study.

Clin Pharmacol Ther 2019 05 18;105(5):1234-1243. Epub 2019 Jan 18.

Merck & Co., Inc., Kenilworth, New Jersey, USA.

β-site amyloid precursor protein cleaving enzyme 1 (BACE1) is required for the production of β-amyloid (Aβ) peptides and is considered a potential treatment target for Alzheimer's disease (AD). To support Japan's participation in the global clinical development program, we characterized the safety, pharmacokinetics (PKs), and pharmacodynamics of the BACE1 inhibitor verubecestat (MK-8931) in 24 healthy Japanese adults in a two-part, single-center, randomized, placebo-controlled phase I trial (protocol MK-8931-007) and compared the results with historical data from non-Japanese subjects. Both single (20, 100, and 450 mg) and multiple (80 and 150 mg once daily for 14 days) doses of verubecestat were well tolerated. Read More

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The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.

Pharmacoepidemiol Drug Saf 2018 11 25;27(11):1265-1276. Epub 2018 Sep 25.

Faculty of Pharmaceutical Sciences, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.

Purpose: To determine if concerns toward adverse reactions (ARs) identified during the drug approval process are associated with their post-approval addition to package inserts.

Methods: Pre-approval concerns toward 24 target ARs were identified in the drug review reports and initial package inserts of 126 target drugs approved for use in Japan between April 2004 and March 2009. Each target drug was monitored for 5 years after approval for the addition of these ARs as clinically significant adverse reactions (CSARs) in the package inserts. Read More

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November 2018