Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development

Author:

Sathuluri Kiranmayi,Bakam RamyaSri,Jain Riya,Dande Aishwarya,Gajbhiye Rahul,Ravichandiran V.,Peraman Ramalingam

Publisher

Springer Science and Business Media LLC

Reference37 articles.

1. Mokhtar HI, Abdel-Salam RA, Hadad GM (2015) Design space calculation by in silico robustness simulation with modeling error propagation in QbD framework of RP-HPLC method development. Chromatographia 78(7–8):457–466. https://doi.org/10.1007/s10337-015-2858-2

2. Raman NVVSS, Mallu UR, Bapatu HR (2015) Analytical quality by design approach to test method development and validation in drug substance manufacturing. J Chem. https://doi.org/10.1155/2015/435129

3. ICH Q8 (2009) EMEA/CHMP, 2009, ICH Topic Q 8 (R2) Pharmaceutical Development, Step 5: Note for Guidance on Pharmaceutical Development. Regul. ICH, vol 8, no June

4. Borman P, Chatfield M, Nethercote P, Thompson D, Truman K (2007) The application of quality by design to analytical methods. Pharm Technol 31:142–152

5. Hanna-Brown M, Borman P, Bale S, Szucs R, Roberts J, Jones C (2010) Development of chromatographic methods using QbD principles. Sep Sci 2:12–20

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