Shimazawa Rumiko

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Potential?adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech).

Approvals of type 2 diabetes drugs tested in cardiovascular outcome trials: A tripartite comparison

Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes

Challenges to hemoglobin A1c as a therapeutic target for type 2 diabetes mellitus

Regulatory requirements for companion diagnostics-Japan

Natural language processing-based assessment of consistency in summaries of product characteristics of generic antimicrobials.

Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels

Pharmacogenomic biomarkers on drug labels: interpretation of United States and Japanese labels based on Pharmacogenetics Knowledgebase

Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: A cross-sectional study

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety

Drug-diagnostic co-development: challenges and issues

DEVELOPMENT OF DRUG-APPROVAL REGULATIONS FOR MEDICAL COUNTERMEASURES AGAINST CBRN AGENTS IN JAPAN

International differences in companion diagnostic approvals: how are we able to manage the differences?

Conflicts of interest in psychiatry: Strategies to cultivate literacy in daily practice

Guidance for peptide vaccines for the treatment of cancer

Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan

Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan

Are there any differences in the regulations of personalized medicine among the USA, EU and Japan?

Safety information in drug labeling: a comparison of the USA, the UK, and Japan

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Study on drug utilization, research and development of intractable disease treatment using the database

Drug information and prescription for older adults

Study on effective drug safety information based on investigation of boxed warning

How to develop a good patient information leaflet of a medicine

Assessment of regulatory efforts to facilitate the approval of off-label drugs

Regulatory science research on drug develpment, review, and post-marketing regulation

Development of novel class of Cdc25A inhibitor by combination of hydrophilic and hydrophobic group

Total synthesis of Salinosporamide A, a potent proteasome inhibitor