Concepedia

Japanese Regulatory System for Approval of Off-Label Drug Use: Evaluation of Safety and Effectiveness in Literature-Based Applications

Rumiko Shimazawa, Masayuki Ikeda

Clinical Therapeutics · 2012 · 27 citations · 11 references

DOI

Concepts

References

11

Off-label Prescribing Among Office-Based Physicians

David Radley, Stan N. Finkelstein, Randall S. Stafford · Archives of Internal Medicine · 2006 · 708 citations

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U.S. physician knowledge of the FDA‐approved indications and evidence base for commonly prescribed drugs: results of a national survey

Donna T. Chen, Matthew K. Wynia, Rachael Moloney et al. · Pharmacoepidemiology and Drug Safety · 2009 · 96 citations · Full text

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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

, , +7

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

, , +7

Exploring Differences in Drug Doses Between Japan and Western Countries

Frank Arnold, Makiko Kusama, Shunsuke Ono · Clinical Pharmacology & Therapeutics · 2010 · 66 citations

, , +11