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- W798368251 abstract "Since the advent of the EU Paediatric Regulation in 2007, 78 of the 1688 Paediatric Investigation Plans (PIPs) have been for monoclonal antibodies (Mabs). Of these, 22 have been assessed by the MHRA. The purpose of this mini-review is to aid those researching and developing this class of drugs to better understand regulatory concerns leading to improved medicinal products for children. Three principal quality issues were identified for PIPs under Article 7 and 8: i) the level of anti-aggregation stabilisers, ii) acceptability and tolerability of administration (i.e. multiple injections, infusion time and volume), and iii) the need to develop new presentational forms (e.g. pre-filled syringe). Overall, two types of concerns were ascertained - those which are potentially avoidable (e.g. through development of new presentational forms) and others which require the evolution of new technologies in the sector (e.g. production of concentrated, stabilised preparations)." @default.
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- W798368251 date "2015-08-01" @default.
- W798368251 modified "2023-09-25" @default.
- W798368251 title "Quality considerations of paediatric investigation plans for monoclonal antibodies: A regulatory perspective from the MHRA" @default.
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- W798368251 doi "https://doi.org/10.1016/j.ijpharm.2015.05.014" @default.
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