Bioequivalence and Bioavailability Forum

We are planning for a BE study of Nicotine Chewing gum

1) Innovator adds Overages (unofficial data, supported by assay values (mean of 10 gums) of 10 batches (106 -108%)

Justification for their overage may be - manufacturing loss/nicotine in the cud after chewing for 30 minutes is around 20%
Our product doesn't need any overages (no manufacturing loss, cud analysis after chewing is 0%)
Obviously assay value of our product will be 95- 100%, even if it is 100%, there is a minimum difference of 6% (more than 5% limit given in the EU guideline)
How can we justify this?

2) Baseline correction

LLOQ = 10 - 12% of Cmax, so if we go without baseline (0 -12% error adds up)
Is it better to go with baseline or without baseline correction?

3) Exclusion criteria

LLOQ being 10 -12% (How can we exclude subjects with baseline more than 5% of Cmax?)

Please can you clarify/suggest -

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Edit: Category changed and subject line changed. Helmut