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The following message was posted to: PharmPK
We have many formulations (tablets) of Levonorgestrel (Levo) and
Ethinylestradiol (EE) combination. All these tablets contain "high potency
APIs (hormones)"of different strengths but have same weights and same
formula (only change in lactose qty to accommodate change in API strength).
To simplify, I am putting three formulations only.
Product 1 Levo 0.15 mg + EE 0.03 mg
Product 2 Levo 0.125 mg + EE 0.03 mg
Product 3 Levo 0.25 mg + EE 0.05 mg
- If we conduct bioequivalence study for product 3, can we get biowaiver for
- If we get, how will we conduct comparative dissolution of product 2 with
product 1? That is, can we do comparison by percentage release method?
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