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Tina ★ India, 2013-06-10 06:47 (4354 d 01:06 ago) Posting: # 10762 Views: 8,558 |
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Dear all, I am currently planning a placebo-controlled clinical trial. Request the team to help me with the in vitro tests to be conducted with the placebo for regulatory submission please. Dissolution tests cant be done as active is not present in the placebo. Stability tests might be required. I am not very sure of the tests required for IMPD preparation and CTA application for trials involving placebo. Thank the members in advance for the kind guidance. |
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Helmut ★★★   Vienna, Austria, 2013-06-10 14:51 (4353 d 17:02 ago) @ Tina Posting: # 10763 Views: 7,073 |
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Hi Tina, ❝ Request the team to help me There is no team.  ❝ Dissolution tests cant be done as active is not present in the placebo. Stability tests might be required. Stability of what? — 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 |
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Ohlbe ★★★ France, 2013-06-10 16:48 (4353 d 15:05 ago) @ Helmut Posting: # 10765 Views: 7,019 |
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Dear Helmut, ❝ Stability of what? Of the physical properties of the tablets: after a few months of storage they may desagregate, turn yellow, etc. — Regards Ohlbe |
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Dr_Dan ★★ Germany, 2013-06-11 11:39 (4352 d 20:14 ago) @ Tina Posting: # 10768 Views: 7,038 |
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Dear Tina First of all a placebo is a drug without active ingredient intended to be administered to humans. Therefore you need to ensure, that (like a drug with active ingredient) the excipients are safe (TSE/BSE certificates) and do not alter within the time intended for the clinical conduct. For studies to be conducted in the EU you consequently need an IMPD also for the placebo. However, dissolution or disintegration tests will not be required. In a second step you have to think about: - is the study open, single-blinded or blinded? - is it a parallel or cross-over design? in order to evaluate if you really need a placebo that exactly matches (shape, weight, colour) the comparitor or if you could use a commercially available placebo which would make the preparation of the IMPD much easier. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Tina ★ India, 2013-06-11 15:28 (4352 d 16:26 ago) @ Dr_Dan Posting: # 10769 Views: 6,998 |
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Dear Dan and Ohlbe, Thank both for guidance. The placebo will require a IMPD as we are planning to do CT in the EU. I havent handled IMPD before. Are there guidalines/guidances for IMPD preparation? What specific requirements are required to be furnished for a placebo in the IMPD? Thank you in advance for the kind guidance. Kind regards, Tina Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2013-06-11 17:18 (4352 d 14:36 ago) @ Tina Posting: # 10770 Views: 7,377 |
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Hi Tina! ❝ 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. — 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 |
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Tina ★ India, 2013-06-12 18:17 (4351 d 13:36 ago) @ Helmut Posting: # 10777 Views: 6,981 |
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luvblooms ★★ India, 2013-06-17 09:40 (4346 d 22:13 ago) @ Tina Posting: # 10804 Views: 6,897 |
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Dear Tina Intended market? Canada or EU ? Requirements are different for different regulatory authorities. Health Canada:Asks for full API data (batch number, manufacturing process, Structure elucidation, impurities, stability, and almost full DMF information (restricted and un restricted part: you have to get an access letter from DMF supplier if DMF has been filed in Canada), Batch number used in manufacturing the clinical lot). Apart from this HC asks for full formulation information (not limiting to manufacturing process, Method of analysis, validation protocols, dissolution details, sufficient stability data of the formulation to be dosed to define the storage period (~3 month stability), impurities profile and many more thing. EMEA: A bit lenient. If you have a lab batch data (specially 6 month stability)with similar composition, you can go ahead with the IMPD and CTA filing. For Placebo also you need to give all the data related to excipients under use, their grade, TSE/BSE certificate, stability data, absence of API data, manufacturing process and other process related details. — ~A happy Soul~ |
Ing. Helmut Schütz