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Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics

The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it i...

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Detalles Bibliográficos
Autores principales: Li, Zhaoyang, Easton, Rachael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5800388/
https://www.ncbi.nlm.nih.gov/pubmed/29035675
http://dx.doi.org/10.1080/19420862.2017.1392424