Bioequivalence Trial of Pegylated Interferon Alfa-2a [Design Issues]

posted by raghavendra_s – 2010-01-07 12:59 (6012 d 09:51 ago) – Posting: # 4570
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Dear Friends,

This is regarding a designing issue of Bioequivalence Trial of a Biologic Product.

How to carry out Bioequivalence study of Pegylated Interferon Alfa-2a ?

Enzyme linked sensitive Immunoassay is available for quantification of Pegylated Interferon Alfa-2a in Human serum.

In order to prove Bioequivalence, only PK studies are sufficient ?

If any additional PD studies also required to prove the Bioequivalence ?

Kindly suggest the appropriate information, if any.

Thanks in advance.

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