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10.1111/cts.13660 · 2023 · External reference

New horizon in clinical development strategy in Japan based on new guideline on Japanese phase 1 studies prior to multi-regional clinical trials

10.1111/cts.70257 · 2025 · External reference

Drug loss in Japan: a comparative analysis with Europe for new drugs developed by emerging biopharma companies

10.1002/cpt.70001 · 2026 · External reference

The strengthening of the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies

10.1016/s0140-6736(07)61602-x · 2007 · External reference

Evolving landscape of new drug approval in Japan and lags from international birth dates: retrospective regulatory analysis

10.1002/cpt.2080 · 2021 · External reference

Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and western countries

10.1007/s10637-014-0080-y · 2014 · External reference

Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

10.1007/s10147-015-0825-4 · 2015 · External reference

Labour and Welfare/Pharmaceuticals and Medical Devices Agency. The background and content of the notification

2025 · External reference

Differences in approved doses and drug lag in drugs approved between 2012 and 2021: a comparison between Japan and the U.S

10.1248/bpb.b25-00030 · 2025 · External reference

Surveys/research exploring Japanese phase I studies in global drug development: are they necessary prior to joining global clinical trials?

10.1002/cpdd.1044 · 2021 · External reference

Cost and duration of clinical trials in drug development by Japanese pharmaceutical companies

2025 · External reference

Globalization of clinical trials: variation in estimated regional costs of pivotal trials, 2015-2016

10.1177/1740774519839391 · 2019 · External reference