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I have one question,
In Biequivalence studies, Is it necessary to do post study
evaluation. If so, generally post study evaluation means after end
of the second period.
Is there any specific studies which are necessary for post period
evaluation for safety of subjects i.e at the end of both periods.
Here I have one doubt. After end of period-I, if any parameter (e.g.
haemoglobine, bilrubin, etc) find out or reference, what will we do?
can we take him for second period? or If we take him to second
period, on what basis can we take him?
any information is appreciable
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It all depends on the study protocol. Generally it is better to do a
basic panel of tests at the end of the last period for all drugs. It
can include Hematology (Hb%, RBC, WBC and platelet count),
Biochemistry (bilirubin, urea, creatinine). If the study drug is
known to cause elevation of liver enzymes, you can add ALT and AST.
If the study drug is known to cause ECG abnormalities, it is better
to do an ECG at check out. Recently we did a diuretic study and the
sponsor specifically requested electrolyte measurements at check in,
t max and check out of each period. The protocol included detection
of abnormal electrolyte level as a withdrawa criteria. Cost wise,
these tests do not amount to a lot but safety wise, they are useful.
We have picked up enzyme, bilirubin elevations post study. From the
legal point of view, post study assessment will offer some (I
think!!) protection against mischeivous litigation. There is a text
book "Drug safety assessment in clinical trials" by Gene S. Gilbert.
It is an excellent book. Appendix 4 gives a list of all major lab
parameters and the % increase/decrease over pre study value which is
clinically significant. If the difference is significant, it needs
to be recorded as an adverse event and followed up.
Dr.S.Sree Rekha, MD
Head - clinical
Micro Therapeutic Research Labs Pvt Ltd,
No.33, Hasthinapuram Main Road,
Nehru Nagar, Chromepet, Chennai - 44
Ph : 044 - 22238846, 56
Fax : 044 - 22238866
Web : www.microtheraps.com
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