Bioequivalence and Bioavailability Forum

Dear Raghavendra,

It will be better to safety analysis to be on safer side because this will prove that subject lost to follow up was due to his personal problems or not due to any Adverse event with your drug.

And you can also file an protocol deviation for same with proper explanation.

Regards,
Dr.Sridhar

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Dear Mr.Raghavendra,

It is advisable to do the safety laboratory evaluation on the day of arrival of subject even it deviates from the protocol and the same should be addressed as protocol deviation.

Regards,
Dr.S.Gunasakaran,MBBS,MD

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

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.