What are the requirements in France to perform a bioequivalence study with Buprenorphine in France? What is the acceptance interval to be used for AUC und CMax?
France is a part of EU and a common guideline for EU members for BE studies was proposed by EMA in GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE here you can find all the necessary details:
Even if national regulations exist (national approval procedures in European countries) then I don't think that national regulators suggest another approach than EMA ....
Thank you Thomasz, since 12th November 2019, a list of NTI drugs have been published by the authorities and Buprenorphine, for its use as substitution therapy, is part of this list of 13 products. Does this mean that results of a BE study have to meet the constraint of the interval of [ 90% - 111%], although it has a broad therapeutic range. Buprenorphine is equally effective for the treatment of opioid dependence as the full agonist methadone, but safer in overdose due to its ceiling effect on respiratory depression. Buprenorphine has lower abuse potential and fewer withdrawal symptoms when discontinued (Raisch et al., 2002). Abrupt withdrawal of buprenorphine produces only a mild abstinence syndrome, which may be delayed in onset (Buckingham, 2019a).