Bioequivalence and Bioavailability Forum

❝ For Bioequivalence study conducted on patients, do we need to provide financial compensation to patients for the participation i.e. Housing or blood loss for Pharmacokinetic evaluation? any guideline from DCGI/ICMR or any regulatory body?

If the trial participants are compensated for their participation in the trial, the IRB/IEC should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence on the trial participants. Payments to a participant should be prorated and not wholly contingent on completion of the trial by the participant. Reasonable reimbursement of participants for travel and lodging is not typically coercive.