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Preclinical safety evaluation for peptide pharmaceuticals at PMDA
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- NAOTA Misaki
- Pharmaceuticals and Medical Devices Agency
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- MAKI Kazushige
- Pharmaceuticals and Medical Devices Agency
Bibliographic Information
- Other Title
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- PMDAにおけるペプチド医薬品の非臨床安全性評価の考え方
Description
<p> Any specific safety guidelines for peptide pharmaceuticals are not available so far. Since ICH S6 states “The principles outlined in this guidance may also be applicable to…chemically synthesized peptides…”, PMDA applies “case-by-case basis approach” described in ICH S6 to safety evaluation of peptide pharmaceuticals. Since there are a variety of peptide pharmaceuticals, the non-clinical safety evaluation should be assessed based on each property (e.g. biological activity, chemical structure, chemical modification). </p><p> In this presentation, our preclinical consideration for peptide pharmaceuticals will be provided.</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 47.1 (0), W1-1-, 2020
The Japanese Society of Toxicology
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Details 詳細情報について
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- CRID
- 1390285697591822976
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- NII Article ID
- 130007898612
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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