Bioequivalence and Bioavailability Forum

Dear Members,

With respect to conduct of BA/BE study with rectal suppositories, is there any guidance document (from any regulatory agency)?

Also as a part of checking compliance to dosing of medication, for oral formulation, a mouth check is performed after dosing the volunteer. Is there any parallel procedure for this while dosing is with rectal suppository? If not how to ensure that dosing is done properly?

Please clarify.

Thanks in advance.

Regards,

Nagashayana