Cathy Woan-Shu Chen

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  • C W Chen
  • Zhonghua gan zang bing za zhi = Zhonghua…
  • 2016
Currently, the diagnostic criteria for drug-induced liver injury (DILI) used in the clinical studies and related literature in China are very confusing, making it difficult to compare and extend the use of the results, conclusions, and experience of these studies. Therefore, it is necessary to carefully review the developmental history of diagnostic scales(More)
It is important to remember that while a new class of therapeutic agents like oligonucleotides may introduce novel concerns, the basic regulatory issues regarding the chemistry, manufacturing, and controls of drug substances and drug products must be addressed. This article focuses on information that should be included in an Investigational New Drug(More)
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