Bioequivalence and Bioavailability Forum

Dear All

I have two questions

1. What is the difference between tablet and film tablet/MR film tablet.

What is the impact in obtaining the consent form healthy volunteers in a BA/BE study when study information consent(ICF/ICD) cpatured drug name xxxx tablet, where as in product IP name mentioned as XXXXX film tablet or XXXXX MR film tablet.

2. In general for any BA/BE studies once IPs are received at the clinical site/CRO from sponsor and found if any discrepancy in receipt of IPs the same shall be informed to sponsor.

whether dispensing of drugs can be proceeded before receiving/closure of IP discrepancies from sponsor end.

Regards
G.Balavivekanand