Bioequivalence and Bioavailability Forum • Bioequivalence Trial of Pegylated Interferon Alfa-2a

raghavendra_s
★

2010-01-07 12:59
(6012 d 21:34 ago)

Posting: # 4570
Views: 4,149

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

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.

Helmut
★★★

Vienna, Austria,
2010-01-07 15:06
(6012 d 19:26 ago)

@ raghavendra_s
Posting: # 4574
Views: 4,175

Biosimilar Peg. Interferon Alfa-2a

Post reply

Dear Raghavendra,

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

The most comprehensive documents are EMA's:

Although a cross-over design is recommended in the general guideline for PK studies, I've seen sequence effects in all (!) studies. Many companies opt for a parallel design instead.

❝ Enzyme linked sensitive Immunoassay is available for quantification of

❝ Pegylated Interferon Alfa-2a in Human serum.

Sure. But don't forget that you have to validate commercial kits as well (sometimes a cumbersome task).

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

No (see linked guidelines).

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raghavendra_s ★ 2010-01-07 18:44 (6012 d 15:49 ago) @ Helmut Posting: # 4577 Views: 3,201	Biosimilar Peg. Interferon Alfa-2a Post reply
	Dear sir, Thank you for valuble information. Kind regards, Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]