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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...

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Bibliografski detalji
Izdano u:Clin Transl Sci
Glavni autori: Cox, Erica M., Edmund, Anita V., Kratz, Erica, Lockwood, Sarah H., Shankar, Aishwarya
Format: Artigo
Jezik:Inglês
Izdano: John Wiley and Sons Inc. 2020
Teme:
Online pristup:https://ncbi.nlm.nih.gov/pmc/articles/PMC7214660/
https://ncbi.nlm.nih.gov/pubmed/31909876
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12745
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