Bioequivalence and Bioavailability Forum

Hi Norah,

❝ […] is there any specific recommendation for BE studies concerning psychotropic ?

None that I recall.

❝ […] for quetiapine should we use the less existing dose (for safety reasons) or we can use the higher dose ??

The FDA recommends three studies: Single dose 25 mg fasting and fed in healthy subjects and 300 mg steady state in schizophrenic patients already receiving quetiapine in a stable regimen.

Whether studies in healthy subjects are possible at all depends on the local legislation. F.i., in China studies of narcotics are prohibited. However, such studies are possible in Hong Kong (doublethink?)… In other countries the procedure is burdensome. In India (once the protocol was accepted by the DCGI and IEC) you have to submit the entire stuff to the Central Bureau of Narcotics (which is notoriously slow).

Furthermore, in many countries handling of narcotic drugs (as IMPs in studies) is regulated in the respective National Medicines Laws and/or Bylaws depending on the Schedule of the drug. This includes procedures for restricted access to storage areas, resistance classes of safes, etc.