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Hello All,
Does anyone have experience changing a comparator drug in a clinical trial from a brand comparator to a generic comparator. Currently our brand name is running out of product, so in order to continue the study arm we will need to move to a generic. The generic has the same excipients and strength of the branded drug product, so it should be bioequivalent. Unfortunately this affects our US and EU studies. For the US studies we will use a US generic and in the EU we anticipate using an EU generic.
Any help on the topic would be greatly appreciated,
Thanks,
ANON