Risk-based approach for method development in pharmaceutical quality control context: A critical review
Pharmaceutical regulatory bodies increasingly require the implementation of systematic
approaches in pharmaceutical product development. Quality control methods play a key role …
approaches in pharmaceutical product development. Quality control methods play a key role …
Drilling into “Quality by Design” approach for analytical methods
L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2024 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …
pharmaceutical product development and manufacturing on robust analytical data. The …
Development and optimization of liquid chromatography analytical methods by using AQbD principles: Overview and recent advances
T Tome, N Žigart, Z Časar… - Organic process research …, 2019 - ACS Publications
This review presents the Analytical Quality by Design (AQbD) concept, an extension of
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …
Pollutants in aquatic system: a frontier perspective of emerging threat and strategies to solve the crisis for safe drinking water
Water is an indispensable natural resource and is the most vital substance for the existence
of life on earth. However, due to anthropogenic activities, it is being polluted at an alarming …
of life on earth. However, due to anthropogenic activities, it is being polluted at an alarming …
A quality by design (QbD) approach in pharmaceutical development of lipid-based nanosystems: A systematic review
DM Zagalo, BMA Silva, C Silva, S Simoes… - Journal of Drug Delivery …, 2022 - Elsevier
Over the last few decades, there has been an impressive progress on develo** novel drug
delivery systems and targeted therapies through the use of Nanotechnology. In particular …
delivery systems and targeted therapies through the use of Nanotechnology. In particular …
Design of experiments in liquid chromatography (HPLC) analysis of pharmaceuticals: Analytics, applications, implications and future prospects
SB Ganorkar, AA Shirkhedkar - Reviews in Analytical Chemistry, 2017 - degruyter.com
This review presents the essential brief annals, crucial analytics, precise applications and
noteworthy implications of design of experiments which enrouted to liquid chromatography …
noteworthy implications of design of experiments which enrouted to liquid chromatography …
Integrated analytical quality by design (AQbD) approach for the development and validation of bioanalytical liquid chromatography method for estimation of valsartan
S Bandopadhyay, S Beg, OP Katare… - Journal of …, 2020 - academic.oup.com
The present studies describe the systematic development and validation of a simple, rapid,
sensitive and cost-effective reversed-phase high-performance liquid chromatographic …
sensitive and cost-effective reversed-phase high-performance liquid chromatographic …
Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine …
A new simple, rapid and sensitive reversed-phase high-performance liquid chromatography
(RP-HPLC) method was developed by employing Quality by Design (QbD) approach for …
(RP-HPLC) method was developed by employing Quality by Design (QbD) approach for …
Application of chemometric approach for QbD-enabled development and validation of an RP-HPLC method for estimation of methotrexate
The present work describes Quality by design (QbD)-oriented development of a reverse
phase high performance liquid chromatographic (RP-HPLC) method for quantification of …
phase high performance liquid chromatographic (RP-HPLC) method for quantification of …
[HTML][HTML] Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form
A Gundala, K Prasad, B Koganti - Brazilian Journal of Pharmaceutical …, 2019 - SciELO Brasil
A simple, sensitive, precise, accurate and robust high performance liquid chromatographic
method has been developed for simultaneous estimation of saxagliptin (SAXA) and …
method has been developed for simultaneous estimation of saxagliptin (SAXA) and …