Analytical quality by design: a tool for regulatory flexibility and robust analytics
R Peraman, K Bhadraya… - International journal of …, 2015 - Wiley Online Library
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 …
applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical …
Q2 (R1) validation of analytical procedures: text and methodology
P Borman, D Elder - ICH quality guidelines: an implementation …, 2017 - Wiley Online Library
Summary International Conference on Harmonisation (ICH) Q2 (R1) provides a formal
overview of the criteria required to fully validate an analytical procedure. It highlights that the …
overview of the criteria required to fully validate an analytical procedure. It highlights that the …
Selection of analytical technology and development of analytical procedures using the analytical target profile
P Borman, C Campa, G Delpierre, E Hook… - Analytical …, 2021 - ACS Publications
A structured approach to method development can help to ensure an analytical procedure is
robust across the lifecycle of its use. The analytical target profile (ATP), which describes the …
robust across the lifecycle of its use. The analytical target profile (ATP), which describes the …
Quality by design: multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before …
K Monks, I Molnár, HJ Rieger, B Bogáti… - … of Chromatography A, 2012 - Elsevier
Robust HPLC separations lead to fewer analysis failures and better method transfer as well
as providing an assurance of quality. This work presents the systematic development of an …
as providing an assurance of quality. This work presents the systematic development of an …
Establishment and reliability evaluation of the design space for HPLC analysis of six alkaloids in Coptis chinensis (Huanglian) using Bayesian approach
DAI Sheng-Yun, XU Bing, Y Zhang, LI Jian-Yu… - Chinese Journal of …, 2016 - Elsevier
Coptis chinensis (Huanglian) is a commonly used traditional Chinese medicine (TCM) herb
and alkaloids are the most important chemical constituents in it. In the present study, an …
and alkaloids are the most important chemical constituents in it. In the present study, an …
Analytical procedure validation and the quality by design paradigm
Since the adoption of the ICH Q8 document concerning the development of pharmaceutical
processes following a quality by design (QbD) approach, there have been many discussions …
processes following a quality by design (QbD) approach, there have been many discussions …
Analytical lifecycle management (ALM) and analytical quality by design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide …
J Teng, C Zhu, J Lyu, L Pan, M Zhang, F Zhang… - … of Pharmaceutical and …, 2022 - Elsevier
Analytical procedure development for quantifying 10 impurities in Tenofovir Alafenamide
Fumarate (TAF) tablets was a challenge for analytical and formulation researchers. The aim …
Fumarate (TAF) tablets was a challenge for analytical and formulation researchers. The aim …
Quality by design compliant strategy for the development of a liquid chromatography–tandem mass spectrometry method for the determination of selected polyphenols …
Diospyros kaki fruits possess great beneficial properties for human health due to their strong
antioxidant and antiradical activities related to the high level of bioactive compounds and …
antioxidant and antiradical activities related to the high level of bioactive compounds and …
Development and optimization of SPE-HPLC-UV/ELSD for simultaneous determination of nine bioactive components in Shenqi Fuzheng Injection based on Quality by …
L Wang, H Qu - Analytical and bioanalytical chemistry, 2016 - Springer
A method combining solid phase extraction, high performance liquid chromatography, and
ultraviolet/evaporative light scattering detection (SPE-HPLC-UV/ELSD) was developed …
ultraviolet/evaporative light scattering detection (SPE-HPLC-UV/ELSD) was developed …
[PDF][PDF] Box-Behnken design assisted optimization and standardization of chromatographic methodology for quality assessment of metformin: analytical quality by …
SS Suryawanshi, MS Palled - Indian J Pharm Educ Res, 2022 - researchgate.net
Background: Metformin (MET) is an oral antidiabetic agent falls chemically under the
category of biguanides and it is effectively utilized in the management of type 2 diabetes …
category of biguanides and it is effectively utilized in the management of type 2 diabetes …