Publications by authors named "Takashi Tanaharu"
Article Synopsis
- The US FDA has mandated the use of the Standard for Exchange of Nonclinical Data (SEND) for pharmaceutical companies developing new drugs in the US market.
- The Japan Pharmaceutical Manufacturers Association (JPMA) initiated a project to analyze SEND datasets specifically for toxicology studies, uncovering variations in how data is populated.
- The Taskforce Team recommends minimizing these variations in both SEND datasets and study protocols to improve data quality, making it easier for regulatory agencies to review and enhancing the overall efficiency of new drug development.
The main focus of this study is to determine the optimal administration period concerning toxic effects on ovarian morphological changes in a repeated-dose toxicity study. To assess morphological and functional changes induced in the ovary by bromocriptine, the compound was administered to female rats at dose levels of 0, 0.08, 0.
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