Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases. Here, we evaluated the recommendations and information available from select clinical pharmacology studies in the therapeut...

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Detalles Bibliográficos
Autores principales: Hsieh, Julie, Sahre, Martina, Yang, Xinning, Madabushi, Rajanikanth, Ramamoorthy, Anuradha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9652444/
https://www.ncbi.nlm.nih.gov/pubmed/36165094
http://dx.doi.org/10.1111/cts.13362

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9652444/
https://www.ncbi.nlm.nih.gov/pubmed/36165094
http://dx.doi.org/10.1111/cts.13362

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