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Dear all,
Happy new year! I am preparing a protocol for a bioequivalence study
for a highly varialbe drug (ANOVA-CV > 30%), and I will appreciate
your opinion on the likely regulatory acceptibility (FDA) of the
following study designs: replicated 2 formulations, 2 sequences, and
4 periods crossover study, or any suggestions for better BE study
design for a highly variable drug. Thanks.
Yijun
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Hi,
A 'Group Sequence' design may also be considered, however it may come
along with the complexity of interim analysis and number calculations
to meet adequate power for the study.
Regards,
Pankaj.
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Dear Yijun,
Well, the design is fine, but I recomment you use the "replicate"
design. e.g., if subject #1 is given T and then R in first 2 periods,
then in the next 2 periods, again T followed by R should be given. I
mean TR TR is fine, but should NOT be TR RT. The patterns will be
TRTR or RTRT. So your protocol title can include few words like "an
open-label (or blind as per sponsor req.), balanced, randomized,
single dose, two-treatment, four period, fully replicate study of x
subjects".
Do consult your statistician for the no of subjects. You can go in
for 40 / 50 subjects or as per the power and suggestions of
statistician. Since the drug is highly variable, consult your sponsor
and the regulatory guidances if 75-133% limits can be used instead of
usual 80-125% (since its a highly vaiable drug).
Regards,
Dr. Gagandeep Singh
Head - Clinical Research
BioArc Research Solutions
(Alembic Pharma)
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