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Blog

Compelling Presentation of the Biosimilarity Assessment

19.06.17

By Theodor Tiko

The biosimilarity assessment report summarizes and critically presents the similarity exercise data in support of the overall biosimilarity claim,...

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Blog

IMPD as a central document for drug development from early on

20.12.16

By Theo Tiko and Annegret Wiedemann

Our authors reflect on their experience with most recently prepared IMPDs. 

The Investigational Medicinal Product Dossier (IMPD) is a central...

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Blog

Integrated Summary of Immunogenicity (ISI) – an effective approach for reducing regulatory risk

1.12.16

By Paul Chamberlain and Gabriele Dallmann

Our authors summarise in the following the main aspects of the Integrated Summary of Immunogenicity as presented during a...

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We are now Cencora PharmaLex 

PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

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