All Clinical development articles
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JournalImmunological considerations in the development of novel vaccines
Part 1 of this series explored the elements of the immune response that are important to vaccine effectiveness. Part 2 looks at how understanding of the immune response supports prediction of vaccine effectiveness and can optimise clinical development of vaccines. The article then goes on to look at the impact of population diversity.
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JournalRegulatory complexities and challenges of biosimilars
This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.