Type-II Variation [Study Assessment]
Hi QA,
IMHO, this is Type-II Variation (according to the EMA’s Q&A ‘a change that may have a significant impact on the quality, safety or efficacy of the medicinal product’), and, thus, an in-vivo study is required. See also EC 2013/C 223/01, Section B.II.b.3.b).
IMHO, this is Type-II Variation (according to the EMA’s Q&A ‘a change that may have a significant impact on the quality, safety or efficacy of the medicinal product’), and, thus, an in-vivo study is required. See also EC 2013/C 223/01, Section B.II.b.3.b).
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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Decrease in PSD: Need to repeat BE? qualityassurance 2024-07-02 08:32 [Study Assessment]
- Type-II VariationHelmut 2024-07-02 09:37
- Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
- Type-II Variation: Waive in-vivo study by providing in-vitro data? SMA 2024-07-02 16:27
- Type-II Variation: Waive in-vivo study by providing in-vitro data? Relaxation 2024-07-04 12:19
- Type-II Variation: Waive in-vivo study by providing in-vitro data? SMA 2024-07-02 16:27
- Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
- Type-II VariationHelmut 2024-07-02 09:37