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A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in JapanRelationship between drug lag and factors associated with clinical trials in Japan.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.Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.Toward Optimum Benefit-Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles.Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals.Potential factors correlating to the PMDA's decision to waive Japanese Phase 2 and 3 studies for oncology drugs New Drug Application in Japan.Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan.Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency.Anticancer drug development from traditional cytotoxic to targeted therapies: evidence of shorter drug research and development time, and shorter drug lag in Japan.
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P2860
description
article científic
@ca
article scientifique
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articolo scientifico
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artigo científico
@pt
bilimsel makale
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scientific article published on February 2011
@en
vedecký článok
@sk
vetenskaplig artikel
@sv
videnskabelig artikel
@da
vědecký článek
@cs
name
The notorious "drug lag" for oncology drugs in Japan.
@en
The notorious "drug lag" for oncology drugs in Japan.
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type
label
The notorious "drug lag" for oncology drugs in Japan.
@en
The notorious "drug lag" for oncology drugs in Japan.
@nl
prefLabel
The notorious "drug lag" for oncology drugs in Japan.
@en
The notorious "drug lag" for oncology drugs in Japan.
@nl
P2093
P1476
The notorious "drug lag" for oncology drugs in Japan.
@en
P2093
Akihiro Hirakawa
Chikako Shimizu
Kan Yonemori
Kenji Tamura
Masashi Ando
Mayu Yunokawa
Noriyuki Katsumata
Taizo Hirata
Yasuhiro Fujiwara
P2860
P2888
P304
P356
10.1007/S10637-011-9638-0
P577
2011-02-01T00:00:00Z