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RegisterIMPD [Study Performance]
posted by Helmut 
– Vienna, Austria, 2013-06-11 17:18 (4352 d 18:28 ago) – Posting: # 10770
Views: 7,378
Hi Tina!
Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1), Section 2.7.
See the Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials, specifically Section 6.
❝ Are there guidalines/guidances for IMPD preparation?
Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1), Section 2.7.
❝ What specific requirements are required to be furnished for a placebo in the IMPD?
See the Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials, specifically Section 6.
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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Placebo in vitro Tina 2013-06-10 04:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Placebo in vitro Helmut 2013-06-10 12:51
- Placebo in vitro Ohlbe 2013-06-10 14:48
- Placebo in vitro Dr_Dan 2013-06-11 09:39
- Placebo in vitro Tina 2013-06-11 13:28
- IMPDHelmut 2013-06-11 15:18
- No TOFU, pleeeze! Tina 2013-06-12 16:17
- IMPDHelmut 2013-06-11 15:18
- Placebo in vitro Tina 2013-06-11 13:28
- Placebo in vitro luvblooms 2013-06-17 07:40
- Placebo in vitro Helmut 2013-06-10 12:51
Ing. Helmut Schütz