Risk-based approach for method development in pharmaceutical quality control context: A critical review

R Deidda, S Orlandini, P Hubert, C Hubert - Journal of pharmaceutical and …, 2018 - Elsevier
Pharmaceutical regulatory bodies increasingly require the implementation of systematic
approaches in pharmaceutical product development. Quality control methods play a key role …

Multivariate optimization techniques in analytical chemistry-an overview

SLC Ferreira, VA Lemos, VS de Carvalho… - Microchemical …, 2018 - Elsevier
This review presents fundamentals and a critical evaluation of the multivariate optimization
techniques employed by the analytical chemistry. Characteristics of the surface response …

'Quality by Design'approach for the analysis of impurities in pharmaceutical drug products and drug substances

A Dispas, HT Avohou, P Lebrun, P Hubert… - TrAC Trends in Analytical …, 2018 - Elsevier
The pharmaceutical industry is highly regulated by quality policies. The concept of risk
management is strongly integrated into the quality assurance system to ensure …

Chronic prostatitis/chronic pelvic pain syndrome: a disease or symptom? Current perspectives on diagnosis, treatment, and prognosis

J Zhang, CZ Liang, X Shang… - American journal of men's …, 2020 - journals.sagepub.com
Definitive diagnosis and selection of effective treatment for chronic prostatitis/chronic pelvic
pain syndrome (CP/CPPS) are frustrations encountered frequently by urology care providers …

Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013–2015)

S El Deeb, H Wätzig, D Abd El‐Hady… - …, 2016 - Wiley Online Library
This review updates and follows‐up a previous review by highlighting recent advancements
regarding capillary electromigration methodologies and applications in pharmaceutical …

[PDF][PDF] Voltammetric determination of amitriptyline based on graphite screen printed electrode modified with a Copper Oxide nanoparticles

H Beitollai, F Garkani Nejad, S Tajik… - … Journal of Nano …, 2017 - ijnd.tonekabon.iau.ir
A novel electrochemical sensor was proposed for the determination of amitriptyline based
on the copper oxide (CuO) nanoparticles modified graphite screen-printed electrode. CuO …

Quality by design in the chiral separation strategy for the determination of enantiomeric impurities: development of a capillary electrophoresis method based on dual …

S Orlandini, B Pasquini, M Del Bubba, S Pinzauti… - … of Chromatography A, 2015 - Elsevier
Quality by design (QbD) concepts, in accordance with International Conference on
Harmonisation Pharmaceutical Development guideline Q8 (R2), represent an innovative …

Current applications of miniaturized chromatographic and electrophoretic techniques in drug analysis

Z Aturki, A Rocco, S Rocchi, S Fanali - Journal of Pharmaceutical and …, 2014 - Elsevier
In the last decade, miniaturized separation techniques have become greatly popular in
pharmaceutical analysis. Miniaturized separation methods are increasingly utilized in all …

Application of Quality by Design to optimize a stability-indicating LC method for the determination of ticagrelor and its impurities

NR Wingert, JB Ellwanger, LM Bueno, C Gobetti… - European Journal of …, 2018 - Elsevier
Simultaneous analysis of drug compounds and their impurities of degradation and synthesis
became constant in the modern pharmaceutical analysis. Likewise, analytical techniques …

Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities

I Kasagić-Vujanović, B Jančić-Stojanović - Journal of Pharmaceutical and …, 2019 - Elsevier
This paper presents integration of Quality by Design concept in the development of
hydrophilic interactions liquid chromatographic methods for analysis of amitriptyline and its …