Test samples expired for FED study [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2020-03-11 12:39 (1062 d 18:06 ago) – Posting: # 21239
Views: 2,792

Hi

❝ Retest, extend the shelf life if within specs, release for CT?


Right, this is exactly what is also done in phase III trials. But if you use another Test batch you can simply explain this in the clinical overview module 2.5 of the dossier.

Kind regards and have a nice day
Dr_Dan

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