Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways

Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the mar...

Descripción completa

Detalles Bibliográficos
Autores principales: Cox, Erica M., Edmund, Anita V., Kratz, Erica, Lockwood, Sarah H., Shankar, Aishwarya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Tutorial
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214660/
https://www.ncbi.nlm.nih.gov/pubmed/31909876
http://dx.doi.org/10.1111/cts.12745

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214660/
https://www.ncbi.nlm.nih.gov/pubmed/31909876
http://dx.doi.org/10.1111/cts.12745

Ejemplares similares