相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。Analysis of Pediatric Drug Approval Lag in Japan
Eiji Ueyama et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2021)
Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union
Saeko Hirota et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)
Pediatric drug development in Japan: Current issues and perspectives
Hiroyuki Saitou et al.
CLINICAL PEDIATRIC ENDOCRINOLOGY (2020)
Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals
R. Kurzrock et al.
ANNALS OF ONCOLOGY (2019)
Regulatory Trends in Drug Development in Asia Pacific
Fengyun (Vicky) Han et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2019)
Orphan drugs: major development challenges at the clinical stage
Diogo A. Fonseca et al.
DRUG DISCOVERY TODAY (2019)
Orphan Medicines for Pediatric Use: A Focus on the European Union
Winona Rei Bolislis et al.
CLINICAL THERAPEUTICS (2019)
Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study
Jeffrey Wagner et al.
BMJ-BRITISH MEDICAL JOURNAL (2018)
Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study
Jeffrey Wagner et al.
BMJ-BRITISH MEDICAL JOURNAL (2018)
Toward Optimum Benefit-Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles
K. Venkatakrishnan et al.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2016)
Matched analysis on orphan drug designations and approvals: cross regional analysis in the United States, the European Union, and Japan
Manabu Murakami et al.
DRUG DISCOVERY TODAY (2016)
Research and drug development activities in rare diseases: differences between Japan and Europe regarding influence of prevalence
Hirokuni Mizoguchi et al.
DRUG DISCOVERY TODAY (2016)
Regulatory Review Time for Approval of Oncology Drugs in Japan Between 2001 and 2014. Considerations of Changes, Factors That Affect Review Time, and Difference With the United States
Hideki Maeda et al.
JOURNAL OF CLINICAL PHARMACOLOGY (2015)
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and elaboration
Jan P. Vandenbroucke et al.
INTERNATIONAL JOURNAL OF SURGERY (2014)
Critical review of 'Public domain application': a flexible drug approval system in Japan
Y. Ito et al.
ANNALS OF ONCOLOGY (2013)
Japanese Regulatory System for Approval of Off-Label Drug Use: Evaluation of Safety and Effectiveness in Literature-Based Applications
Rumiko Shimazawa et al.
CLINICAL THERAPEUTICS (2012)
Clinical Development and Review Times for New Drugs in Japan: Associated Factors
T. Ishibashi et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2010)
Systematic review: reliability of compendia methods for off-label oncology indications (vol 150, pg 336, 2009)
A. P. Abernethy et al.
ANNALS OF INTERNAL MEDICINE (2009)
Systematic Review: Reliability of Compendia Methods for Off-Label Oncology Indications
Amy P. Abernethy et al.
ANNALS OF INTERNAL MEDICINE (2009)
Approval of new biopharmaceuticals 1999-2006: Comparison of the US, EU and Japan situations
Kaori Tsuji et al.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2008)
分享论文
