Cargando…
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...
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 |
Ejemplares similares
-
Temporary mechanical circulatory support devices: practical considerations for all stakeholders
por: Salter, Benjamin S., et al.
Publicado: (2022) -
Risk Management in Drug-Device Combination Product Development
por: Kumoluyi, Robin, et al.
Publicado: (2022) -
An expanding horizon of complex injectable products: development and regulatory considerations
por: Panchal, Kanan, et al.
Publicado: (2022) -
Statistical and regulatory considerations in assessments of interchangeability of biological drug products
por: Tóthfalusi, Lászlo, et al.
Publicado: (2014) -
Regulatory considerations for generic products of non-biological complex drugs
por: Liu, Yu-Hsuan, et al.
Publicado: (2023)