Cargando...

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...

Descrición completa

Gardado en:
Detalles Bibliográficos
Publicado en:Int J Anal Chem
Main Authors: Peraman, Ramalingam, Bhadraya, Kalva, Padmanabha Reddy, Yiragamreddy
Formato: Artigo
Idioma:Inglês
Publicado: Hindawi Publishing Corporation 2015
Assuntos:
Acceso en liña: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
Tags: Engadir etiqueta
Sen Etiquetas, Sexa o primeiro en etiquetar este rexistro!