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I went through the FDA guidelines BA and BE for Oral solid dosage forms
- General considerations (March 2003) guidelines.I need a
clarification regarding the study design.
When we are doing BE studies for ANDA, the guideline recommends to do a
non-replicate study. But the immediate sentence after this is ý
Ísponsors and or applicants have the option of using replicate designs
forBE study for these drug productsÍţ.
On what basis should I go for replicate study.
Advantages of replicate study is mentioned in the guideline itself. But
if non replicate study is going to cost less then isnÝt always better
to go for non replicate study.
Please clarify my doubt.
Thanks and Regards
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The following message was posted to: PharmPK
In the statistical considerations guideline, it is shown that the
design essentially doubles the power of your study.
For drugs with very high variability (eg, >40 %CV for AUC and Cmax),
find doing a 30 subject study easier to recruit for and conduct than a
person study (which may require sequential dosing and therefore a group
effect would need to be added to the model).
Also, if you want to attempt to use the individual or population
bioequivalence approaches for determining BE (need to meet prospectively
with FDA before conducting study)then you need a replicate design
these approaches need the intrasubject variablity information.
However, if the drug is the 15-20 % CV kind, then going from 12 to 24
as much of a clinical/cost consideration and 2 period crossovers are
Susan E. Shoaf, Ph.D.
Otsuka Maryland Research Institute
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