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Classification of drugs for evaluating drug interaction in drug development and clinical management

Drug metabolism and pharmacokinetics, 2021-12, Vol.41, p.100414-100414, Article 100414

2021

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Designation Products: Boron Neutron Capture Therapy for Head and Neck Carcinoma

The oncologist (Dayton, Ohio), 2021-07, Vol.26 (7), p.e1250-e1255

2021

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Development of a new Japanese guideline on drug interaction for drug development and appropriate provision of information

Drug metabolism and pharmacokinetics, 2020-02, Vol.35 (1), p.12-17

2020

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Malignant melanoma treatment using brachytherapy: Two case reports and 15 case series

Journal of dermatology, 2023-01, Vol.50 (1), p.94-97

2023

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Two cases of advanced cutaneous squamous cell carcinoma lesions on the head and neck successfully treated with nivolumab

Journal of dermatology, 2021-09, Vol.48 (9), p.e434-e435

2021

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Recurrence of Quadruple Extramammary Paget’s Disease after 12 Years: A Case Report and Literature Review

Case reports in dermatology, 2024-06, Vol.16 (1), p.149-155

2024

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Efficacy of amenamevir for the treatment of herpes zoster in an immunocompromised patient: Report of a case

Journal of dermatology, 2019-08, Vol.46 (8), p.e270-e271

2019

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Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan

CPT: pharmacometrics and systems pharmacology, 2020-10, Vol.9 (10), p.550-552

2020

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Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan

Journal of human genetics, 2013-06, Vol.58 (6), p.313-316

2013

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Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments

Pharmacogenomics, 2013-01, Vol.14 (2), p.195-203

2013

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A case of drug‐induced Stevens‐Johnson syndrome‐like eruption predominating in mucosa: A case report

Clinical case reports, 2020-08, Vol.8 (8), p.1379-1381

2020

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Prediction of Severe Adverse Drug Reactions Using Pharmacogenetic Biomarkers

DRUG METABOLISM AND PHARMACOKINETICS, 2010-01, Vol.25 (2), p.122-133

2010

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Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan

Clinical pharmacology and therapeutics, 2022-01, Vol.111 (1), p.35-43

2022

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Current PMDA Activities for Use of Biomarkers in Drug Evaluation

Yakugaku zasshi, 2015-05, Vol.135 (5), p.681-684

Ishiguro, Akihiro

2015

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Current PMDA Activities for Use of Biomarkers in Drug Evaluation

YAKUGAKU ZASSHI, 2015/05/01, Vol.135(5), pp.681-684

Ishiguro, Akihiro

2015

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Type 1 diabetes associated with immune checkpoint inhibitors for malignant melanoma: A case report and review of 8 cases

Medicine (Baltimore), 2022-09, Vol.101 (35), p.e30398

2022

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Current Japanese regulatory situations of pharmacogenomics in drug administration

Expert review of clinical pharmacology, 2008-07, Vol.1 (4), p.505-514

2008

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Common mutant alleles of CYP2D6 causing the defect of CYP2D6 enzyme activity in a Japanese population

British journal of clinical pharmacology, 2003-04, Vol.55 (4), p.414-414

2003

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高LET放射線

ファルマシア, 2020, Vol.56(12), pp.1119_4-1119_4

2020

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第1回　先駆け審査指定制度対象製品に関するPMDAの審査概要：ホウ素中性子捕捉療法による頭頸部がん治療関連製品

ファルマシア, 2020, Vol.56(12), pp.1122-1123

2020

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医薬品評価におけるバイオマーカー利用に向けたPMDAの取り組み

YAKUGAKU ZASSHI, 2015/05/01, Vol.135(5), pp.681-684

石黒, 昭博

2015

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High-throughput detection of multiple genetic polymorphisms influencing drug metabolism with mismatch primers in allele-specific polymerase chain reaction

Analytical biochemistry, 2005-02, Vol.337 (2), p.256-261

2005

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モデリングとシミュレーションを活用した医薬品承認審査の最新動向と今後の規制当局における展望

ファルマシア, 2018, Vol.54(5), pp.433-435

2018

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A long PCR assay to distinguish CYP2D65 and a novel CYP2D6 mutant allele associated with an 11-kb EcoRI haplotype

Clinica chimica acta, 2004-09, Vol.347 (1), p.217-221

2004

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Metabolic activity of dextromethorphan O-demethylation in healthy Japanese volunteers carrying duplicated CYP2D6 genes: duplicated allele of CYP2D610 does not increase CYP2D6 metabolic activity

Clinica chimica acta, 2004-06, Vol.344 (1), p.201-204

2004

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Classification of drugs for evaluating drug interaction in drug development and clinical management

Designation Products: Boron Neutron Capture Therapy for Head and Neck Carcinoma

Development of a new Japanese guideline on drug interaction for drug development and appropriate provision of information

Malignant melanoma treatment using brachytherapy: Two case reports and 15 case series

Two cases of advanced cutaneous squamous cell carcinoma lesions on the head and neck successfully treated with nivolumab

Recurrence of Quadruple Extramammary Paget’s Disease after 12 Years: A Case Report and Literature Review

Efficacy of amenamevir for the treatment of herpes zoster in an immunocompromised patient: Report of a case

Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan

Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments

A case of drug‐induced Stevens‐Johnson syndrome‐like eruption predominating in mucosa: A case report

Prediction of Severe Adverse Drug Reactions Using Pharmacogenetic Biomarkers

Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan

Current PMDA Activities for Use of Biomarkers in Drug Evaluation

Current PMDA Activities for Use of Biomarkers in Drug Evaluation

Type 1 diabetes associated with immune checkpoint inhibitors for malignant melanoma: A case report and review of 8 cases

Current Japanese regulatory situations of pharmacogenomics in drug administration

Common mutant alleles of CYP2D6 causing the defect of CYP2D6 enzyme activity in a Japanese population

高LET放射線

第1回　先駆け審査指定制度対象製品に関するPMDAの審査概要：ホウ素中性子捕捉療法による頭頸部がん治療関連製品

医薬品評価におけるバイオマーカー利用に向けたPMDAの取り組み

High-throughput detection of multiple genetic polymorphisms influencing drug metabolism with mismatch primers in allele-specific polymerase chain reaction

モデリングとシミュレーションを活用した医薬品承認審査の最新動向と今後の規制当局における展望

A long PCR assay to distinguish CYP2D65 and a novel CYP2D6 mutant allele associated with an 11-kb EcoRI haplotype

Metabolic activity of dextromethorphan O-demethylation in healthy Japanese volunteers carrying duplicated CYP2D6 genes: duplicated allele of CYP2D610 does not increase CYP2D6 metabolic activity

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