T/R 90% to 110% for sample size estimation [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2013-11-26 06:36 (3775 d 13:06 ago) – Posting: # 11969
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(edited by kumarnaidu on 2013-11-26 11:08)

Dear all,
If in my earlier studies I am getting T/R ratio= 110% means >5% difference then for planning another study for another market should I go with the T/R=110% or 95% for sample size estimation.

As per EMA guideline (2010) "batches should not differ more than 5%" so taking 10% difference in T/R ratio is considerable.

Also if I am taking the T/R ratio=110% I am getting sample size around 50 (without dropout) but many studies I found for this drug is around 40 even our earlier study had 42. then in that case if am exceeding sample size will it considered as a forced bioequivalence?

Earlier study results used for sample size estimation
LnCmax ratio=110.3 (90%CI- 101.06-120.54) CV=24.3.

Please reply.

Kumar Naidu

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