Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs

FDA’s experience to date has shown that completion of stability data requirements is one of the most observed challenges for applicants of New Drug Applications (NDAs) with an expedited review designation. Since NDAs submitted under these expedited pathways often have limited available real-time sta...

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Detalles Bibliográficos
Autores principales: Furness, M. Scott, Cai, Hong, Chandramouli, Sithamalli, Chelliah, Mariappan, Chen, Xiao Hong, Ghosh, Debasis, Liu, Shaobo, McLamore, Sherita, Randad, Ramnarayan, Shen, Meiyu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9838275/
https://www.ncbi.nlm.nih.gov/pubmed/36631718
http://dx.doi.org/10.1208/s12249-022-02498-0

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9838275/
https://www.ncbi.nlm.nih.gov/pubmed/36631718
http://dx.doi.org/10.1208/s12249-022-02498-0

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