Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan.

@article{Ueno2014SignificantDI,
  title={Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan.},
  author={Takuya Ueno and Yasuhiro Asahina and Asashi Tanaka and Hironao Yamada and Miki Nakamura and Yoshiaki Uyama},
  journal={Clinical pharmacology and therapeutics},
  year={2014},
  volume={95 5},
  pages={
          533-41
        }
}
Although the number of global clinical trials (GCTs) conducted in multiple countries including Japan has increased recently, it is not clear how much these GCTs help in reducing the lag in drug development (LDD: difference between the submission dates for new drug applications (NDAs) in the United States and Japan). We examined the effects of various clinical development strategies on LDD because the development period depends on what types of clinical trials were conducted for the Japanese NDA… CONTINUE READING
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