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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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Détails bibliographiques
Publié dans:Int J Anal Chem
Auteurs principaux: Peraman, Ramalingam, Bhadraya, Kalva, Padmanabha Reddy, Yiragamreddy
Format: Artigo
Langue:Inglês
Publié: Hindawi Publishing Corporation 2015
Sujets:
Accès en ligne: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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