A questionnaire survey on discussions between pharmaceutical companies and PMDA in non-clinical safety assessment of pharmaceuticals
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- MIYAUCHI Makoto
- Mochida Pharmaceutical Co., Ltd.
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- SUZUKI Mutsumi
- Kyowa Kirin Co., Ltd.
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- MIYAWAKI Izuru
- Sumitomo Dainippon Pharma Co., Ltd.
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- KODAMA Terutaka
- EA Pharma Co., Ltd.
Bibliographic Information
- Other Title
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- 医薬品の非臨床安全性評価に関するPMDAと企業との議論に関するアンケート調査結果
Abstract
<p>It is often argued the requirement of the toxicity study or interpretation of the toxicological findings during drug development. Due to short timeline, there are limited opportunities for direct communication between pharmaceutical companies and PMDA. Here, we conducted a questionnaire survey on the differences of opinion in consultations with PMDA, and received responses from 23 companies. The different opinion on guidelines between Japan and other countries were mentioned. We would like to discuss this survey results with participants for mutual understanding between companies and PMDA.</p>
Journal
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- Annual Meeting of the Japanese Society of Toxicology
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Annual Meeting of the Japanese Society of Toxicology 48.1 (0), W4-2-, 2021
The Japanese Society of Toxicology
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Details 詳細情報について
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- CRID
- 1390851961199650560
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- NII Article ID
- 130008073976
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed