Bioequivalence and Bioavailability Forum

Dear Raghavendra!

Another issue in the never-ending fight between science and red tape.

What's the rationale for performing the safety analysis in a BA/BE study 30 days after the last dose?
Unless it's a multiple dose study / a drug with a long half-life any potential AE(s) most likely will have vanished anyhow. Sorry to say, but serious protocols call for the post-treatment examination within a couple of days (one week maximum). Classification of the relationship of an AE to study drug is difficult enough; what if you find elevated liver parameters after one month (not knowing that last week the subject was celebrating his best friend's birthday in the moonshine)?
So if the subject comes in after two months, perform the examination - which I would say is as useless as the per-protocol one - and document it as a deviation.
And consider updating your procedures.