Results 101 to 110 of about 1,590,893 (188)

Development of an Analytical Method for Determination of Related Substances and Degradation Products of Cabotegravir Using Analytical Quality by Design Principles. [PDF]

ACS Omega, 2022
Kovač L, Časar Z, Trdan Lušin T, Roškar R.   +3 more
europepmc   +1 more source

Analytical Quality by Design: A Systematic Review

At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach.
openaire   +1 more source

Scaling up nanoformulation manufacturing: A multi–case study linking target product profiles, critical quality attributes, and quality by design

OpenNano
Nanoformulation platforms have transformed drug delivery; however, reliable scale-up from laboratory to manufacturing remains the principal barrier to clinical translation.
Shriraj B. Patel, Dhanashree P. Sanap
doaj   +1 more source

Quality by Design and Analytical Quality by Design in Pharmaceutical Analytical Method Development: Principles, Tools, and Regulatory Perspectives

A methodical, risk- and science-based approach to pharmaceutical development, Quality by Design (QbD) places an emphasis on incorporating quality into products rather than depending just on end-product testing. It entails creating a Design Space backed by risk assessment and statistical tools like Design of Experiments (DoE), as well as defining the ...
openaire   +1 more source

Analytical quality by design methodology for botanical raw material analysis: a case study of flavonoids in Genkwa Flos. [PDF]

Sci Rep, 2021
Kim MK, Park SC, Park G, Choi E, Ji Y, Jang YP.   +5 more
europepmc   +1 more source

Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using Green Analytical Quality by Design-based UPLC Method. [PDF]

RSC Adv, 2021
Chanduluru HK, Sugumaran A.
europepmc   +1 more source

Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method. [PDF]

Int J Anal Chem, 2021
Alruwaili NK.
europepmc   +1 more source

Analytical Quality by Design: A Mini Review [PDF]

Biomedical Journal of Scientific & Technical Research, 2017
openaire   +1 more source

"Analytical Quality by Design: A Review for Chromatography"

Biomedical Journal of Scientific & Technical Research, 2022
openaire   +1 more source

A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and Opportunities. [PDF]

Ther Innov Regul Sci
Claro BC, Condado EF, Prado LD.
europepmc   +1 more source