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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Bibliografiske detaljer
Udgivet i:Int J Anal Chem
Main Authors: Peraman, Ramalingam, Bhadraya, Kalva, Padmanabha Reddy, Yiragamreddy
Format: Artigo
Sprog:Inglês
Udgivet: Hindawi Publishing Corporation 2015
Fag:
Review Article
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4332986/
https://ncbi.nlm.nih.gov/pubmed/25722723
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1155/2015/868727
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