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

Sample size considerations for Japanese patients in a multi‐regional trial based on MHLW guidance

Hui Quan, Peng‐Liang Zhao, Ji Zhang et al. · Pharmaceutical Statistics · 2009 · 85 citations

Medicine, Biostatistics, Clinical Pharmacology +16

Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan

Yoshiaki Uyama, Toshihiko Shibata, Nao Nagai et al. · Clinical Pharmacology & Therapeutics · 2005 · 72 citations

Pharmacy, Pharmaceutical Policy, Pharmacology +7

Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan

Takeshi Ueno, Yasuko Asahina, Akio Tanaka et al. · Clinical Pharmacology & Therapeutics · 2013 · 71 citations

Medicine, Pharmacology, Clinical Pharmacology +15

Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations

Kaori Tsuji, Kiichiro Tsutani · Journal of Clinical Pharmacy and Therapeutics · 2010 · 70 citations

Pharmacy, Pharmaceutical Policy, Drug Approval Processes +7

Delays in New Drug Applications in Japan and Industrial R&D Strategies

Yutaro Hirai, Hiroto Kinoshita, Makiko Kusama et al. · Clinical Pharmacology & Therapeutics · 2009 · 61 citations

Pharmacy, Pharmaceutical Policy, Clinical Pharmacology +16