よむ、つかう、まなぶ。
【参考資料５】海外で臨床開発が先行した医薬品の国際共同治験開始前の日本人での第Ⅰ相試験の実施に関する基本的考え方について (10 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_41120.html |
| 出典情報 | 医薬品等行政評価・監視委員会（第16回 7／4）《厚生労働省》 |
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Japanese regardless of age and/or indication.
4. Others
Regardless of conducting a phase 1 study in Japanese, it is important to assess the
differences in PK and/or PD between Japanese and non-Japanese through measures
such as collecting PK and/or PD data in Japanese in MRCTs prior to marketing
authorization applications.
If a phase 1 study in Japanese is not conducted, the study sponsor should set additional
safety measures for Japanese participants in MRCTs if the sponsor deems it necessary.
The necessity of a phase 1 study in Japanese and the appropriateness of the safety
measures in MRCTs will be ultimately concluded for each individual drug, and if
PMDA judges it is necessary in order to secure the safety of the Japanese participants,
PMDA may give instructions or advice on the necessity of a phase 1 study in Japanese
or on implementation or changes to the additional safety measures for Japanese
participants in MRCTs in a consultation for clinical trials.
4. Others
Regardless of conducting a phase 1 study in Japanese, it is important to assess the
differences in PK and/or PD between Japanese and non-Japanese through measures
such as collecting PK and/or PD data in Japanese in MRCTs prior to marketing
authorization applications.
If a phase 1 study in Japanese is not conducted, the study sponsor should set additional
safety measures for Japanese participants in MRCTs if the sponsor deems it necessary.
The necessity of a phase 1 study in Japanese and the appropriateness of the safety
measures in MRCTs will be ultimately concluded for each individual drug, and if
PMDA judges it is necessary in order to secure the safety of the Japanese participants,
PMDA may give instructions or advice on the necessity of a phase 1 study in Japanese
or on implementation or changes to the additional safety measures for Japanese
participants in MRCTs in a consultation for clinical trials.