Dissimilar ferric derisomaltose formulations – In vitro comparisons between an originator and its intended similars

Author:

Langguth Peter,Sharma Reetesh,Tulpule Sameer,Hansen Martin,Auerbach Michael

Publisher

Elsevier BV

Reference75 articles.

1. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks;Hussaarts;Ann N Y Acad Sci,2017

2. The similarity question for biologicals and non-biological complex drugs;Crommelin;Eur J Pharm Sci,2015

3. Structure, chemistry, and pharmacokinetics of intravenous iron agents;Danielson;J Am Soc Nephrol,2004

4. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product, https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-iron-based-nano-colloidalproducts-developed_en.pdf, 2015 (accessed April 30, 2024).

5. Nanomedicines: the magic bullets reaching their target?;Flühmann;Eur J Pharm Sci,2019

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