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lsilva ☆ Portugal, 2012-10-08 19:20 (5010 d 03:17 ago) Posting: # 9338 Views: 5,076 |
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Dear all: Is it possible to use pre-pilot batches manufactured under GMP conditions in pilot bridging BA/BE studies and only pilot batches on the pivotal BD/BE study? Best regards |
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jag009 ★★★ NJ, 2012-10-08 20:08 (5010 d 02:29 ago) @ lsilva Posting: # 9339 Views: 4,316 |
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Hi Isilva, Stability? Batch Size? John |
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lsilva ☆ Portugal, 2012-10-08 20:32 (5010 d 02:05 ago) @ jag009 Posting: # 9342 Views: 4,432 |
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Hi John: We intend to have sufficient stability data on this pre-pilot batch to perform the pilot bridging study. It is not clear from the guidelines we know the batch size. We intend to perform a pilot bridging study not only to calculate the appropriate sample size of the pivotal BDBE study but also to make a first test on our formulation. It is important for you to know that our dosage form is different from the dosage form of the reference product although the route of administration is the same. If we have to manufacture a pilot batch to this first study and we need to make small changes in the formulation afterwards in order to ensure pharmaceutical equivalence between our formulation and the reference products the cost will be to high. My question is exactly the minimum bacth size that we can manufacture in order to perform a pilot bridging study. Is it really mandatory to manufacture a pilot batch for this study? Cláudia |
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Dr_Dan ★★ Germany, 2012-10-09 13:36 (5009 d 09:01 ago) @ lsilva Posting: # 9353 Views: 4,401 |
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Dear Cláudia For a pilot study you do not need to have a pilot batch. A batch in lab scale is sufficient as long as this is manufactured under GMP and as long as stability is prooven for the time of study conduct. A pilot study has to be in compliance with ICH-GCP but need not to follow any guideline (it is not a pivotal study). It is in the sponsor's decision what kind of results he expects (proof of concept, etc.) and these results have to be presented in an application dossier to authorities but solely as supportive information. A pilot study with a pilot batch would only make sense if you aim to demonstrate bioequivalence and to use this study as the pivotal BE study Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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lsilva ☆ Portugal, 2012-10-09 13:53 (5009 d 08:44 ago) @ Dr_Dan Posting: # 9354 Views: 4,287 |
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Dear Dan: Thank you for your reply. It was very helpful. Best regards, Cláudia |
Ing. Helmut Schütz