Bioequivalence and Bioavailability Forum

Dear Pravin,

as per the information available:

based on the In house SOP title protocol deviation, the criticality should be mentioned in the SOP based upon the design and the process separately in the study.

To the mentioned case, Are you speaking with respect to P1 or P2, type of study, type of drug, type of release of drug,A DME of the drug, amount of water consumed and what time before the predose.

Does the protocol defines the protocol deviation to what extent?

Based on the criticality withrespect to the process related error,it can be considered as protocol deviation and can be included in the study(Keeping the ethical issues with respect to the volunteer) on discussion with PK department and PI.

If any clarification kinldy let me know.