Загрузка...

Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

CT-P13, the world’s first biosimilar monoclonal antibody to infliximab, was approved for marketing in South Korea for all the six indications of infliximab, which Europe may follow, although the product was tested only in rheumatoid arthritis (RA) with a limited pharmacokinetic comparison in ankylos...

Полное описание

Сохранить в:
Библиографические подробности
Главный автор: Lee, Howard
Формат: Artigo
Язык:Inglês
Опубликовано: Springer US 2013
Предметы:
Online-ссылка:https://ncbi.nlm.nih.gov/pmc/articles/PMC3889539/
https://ncbi.nlm.nih.gov/pubmed/24114449
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9534-y
Метки: Добавить метку
Нет меток, Требуется 1-ая метка записи!