Quality by design approach: Regulatory need
Sign Up to like & getrecommendations! Published in 2017 at "Arabian Journal of Chemistry"
DOI: 10.1016/j.arabjc.2014.01.025
Abstract: Abstract In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share of market. In this context pharmaceutical industry is utmost… read more here.
Keywords: quality; qbd; chemistry; quality design ... See more keywords
Risk assessment and QbD based optimization of an Eprosartan mesylate nanosuspension: in-vitro characterization, PAMPA and in-vivo assessment.
Sign Up to like & getrecommendations! Published in 2019 at "International journal of pharmaceutics"
DOI: 10.1016/j.ijpharm.2019.06.006
Abstract: Quality by design (QbD) principles were implemented to understand the product and process variables of sonoprecipitation technique, for preparation of eprosartan mesylate (EM) nanosuspension. Quality risk management approach was utilized to identify and assess high-risk… read more here.
Keywords: quality; qbd; mesylate nanosuspension; eprosartan mesylate ... See more keywords
QbD Innovation Through Advances in PAT, Data Analysis Methodologies, and Material Characterization
Sign Up to like & getrecommendations! Published in 2019 at "AAPS PharmSciTech"
DOI: 10.1208/s12249-019-1506-9
Abstract: It has been 15 years since the FDA issued its pharmaceutical CGMPs for the 21st-century report laying out its quality by design (QbD) and process analytical technologies (PAT) initiative (1). QbD tenets emphasize the need… read more here.
Keywords: real time; qbd; analysis; process ... See more keywords
Novel Phenobarbital-Loaded Nanostructured Lipid Carriers for Epilepsy Treatment: From QbD to In Vivo Evaluation
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Chemistry"
DOI: 10.3389/fchem.2022.908386
Abstract: Pharmacological treatments of central nervous system diseases are always challenging due to the restrictions imposed by the blood–brain barrier: while some drugs can effectively cross it, many others, some antiepileptic drugs among them, display permeability… read more here.
Keywords: nanostructured lipid; lipid carriers; phenobarbital; formulation ... See more keywords