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FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative...

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Detalles Bibliográficos
Autores principales: Almeter, Philip J., Isaacs, James T., Hunter, Aaron N., Henderson, Bradley S., Platt, Thomas, Mitchell, Billie J., Do, David, Brainard, Alyssa B., Brown, Joshua E., Stone, Rachael M., Nguyen, Bao-Han, Warren, Matthew F., Bhaktawara, Smaran A., Bossle, Megan N., Long, Lindsey M., Zapata, Stephanie P., Larkin, Cinnamon R., Lyman, Thomas A., Larkin, Seth A., Labuhn, Jonathan A., Reynolds, Jeffrey W., Schuler, Erin E., Naseman, Ryan W., Johnson, Gary L., Lodder, Robert A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164582/
https://www.ncbi.nlm.nih.gov/pubmed/35677914
http://dx.doi.org/10.1007/s12247-022-09659-5