TY - JOUR A2 - Marini, Roland AU - Peraman, Ramalingam AU - Bhadraya, Kalva AU - Padmanabha Reddy, Yiragamreddy PY - 2015 DA - 2015/02/02 TI - Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics SP - 868727 VL - 2015 AB - 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 allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT). SN - 1687-8760 UR - https://doi.org/10.1155/2015/868727 DO - 10.1155/2015/868727 JF - International Journal of Analytical Chemistry PB - Hindawi Publishing Corporation KW - ER -