Bioequivalence and Bioavailability Forum

Hello Vivekanand,

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

If a tablet is not modified release then I will assume it is immediate release. The difference is then largely time to drug release. Film tablet (film coated tablet) can mean any of the two categories. The film may be one that just makes it easier to swallow the tablet, or it may be a film that controls drug release, typically gastro-resistant film coating.

❝ 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.

If the subjects have been informed that they are only going to be administered XXX, then you cannot dose both XXX and YYY. At the end it comes down to wording which has to be accurate and specific. If the wording leaves any room for misinterpretation of what the subjects get when and how and why then the consent can be argued not to be 'informed'.

❝ 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.

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

If there is a discrepancy your pharmacist can impound the IMP until things have been sorted. Some discrepancies may be of less serious nature than others. If the CoA says the tablets are "Amoxycillin BogusPharma" and the label/box/blister says "Amoxicillin BogusPharma" then I would worry less than if the CoA identifies the tablets as white round in a situation where you received pink ovals. But all things are relative, they say. What type of discrepancy are we talking about here?