Dataset from A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different Processes
收藏NIAID Data Ecosystem2026-05-02 收录
下载链接:
https://doi.org/10.25934/00007190
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资源简介:
Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the
active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This
bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and
pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved
serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing
process.
创建时间:
2024-11-26



