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raghavendra_s ★ 2010-01-07 12:59 (6018 d 08:50 ago) Posting: # 4570 Views: 4,183 |
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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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Helmut ★★★   Vienna, Austria, 2010-01-07 15:06 (6018 d 06:42 ago) @ raghavendra_s Posting: # 4574 Views: 4,204 |
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Dear Raghavendra, ❝ How to carry out Bioequivalence study of Pegylated Interferon Alfa-2a ? The most comprehensive documents are EMA's:
❝ 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). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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raghavendra_s ★ 2010-01-07 18:44 (6018 d 03:05 ago) @ Helmut Posting: # 4577 Views: 3,235 |
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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] |
Ing. Helmut Schütz