Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval

Abstract Under the International Council for Harmonization (ICH)‐E1 guideline for drugs intended for chronic or repeated intermittent use in non‐life‐threatening diseases, data from 100 patients exposed for a minimum of 1 year are required to be included in the safety data base of a new drug applica...

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Bibliographic Details
Main Authors: Shinobu Uzu (Author), Shohko Sekine (Author), Junichi Asano (Author), Mutsuhiro Ikuma (Author)
Format: Book
Published: Wiley, 2021-11-01T00:00:00Z.
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3rd Floor Main Library

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