Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allo...

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Detalles Bibliográficos
Autores principales: Peraman, Ramalingam, Bhadraya, Kalva, Padmanabha Reddy, Yiragamreddy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2015
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4332986/
https://www.ncbi.nlm.nih.gov/pubmed/25722723
http://dx.doi.org/10.1155/2015/868727

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4332986/
https://www.ncbi.nlm.nih.gov/pubmed/25722723
http://dx.doi.org/10.1155/2015/868727

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