Results 251 to 260 of about 11,237,275 (282)

Evaluation of Critical Quality Attributes of Topical Foam Formulations

AAPS PharmSciTech
Topical foams are widely utilized in dermatology for both cosmetic and therapeutic purposes, owing to their superior spreadability, ease of application over large skin areas, and enhanced patient compliance. As with other topical products, generic foams must exhibit physicochemical properties comparable to their reference listed drug (RLD or innovator ...
Srinath Rangappa, Srinivas Ajjarapu, Vijay Kumar Shankar, Anandavalli Varadarajan, Santanu Kundu, S. Narasimha Murthy   +5 more
openaire   +2 more sources

On the perceived relevance of critical internal quality attributes when evolving software features

, 2023
Several refactorings performed while evolving software features aim to improve internal quality attributes like cohesion and complexity. Indeed, internal attributes can become critical if their measurements assume anomalous values. Yet, current knowledge
Eduardo Fernandes, Marcos Kalinowski
exaly   +1 more source

Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products

Biologicals, 2017
Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory considerations. The composition and manufacturing processes of biosimilar products can differ from those of the reference ...
Ohseok, Kwon, Jeewon, Joung, Younjoo, Park, Chan Wha, Kim, Seung Hwa, Hong   +4 more
openaire   +2 more sources

Outlining critical quality attributes (CQAs) as guidance for the development of orodispersible films

Pharmaceutical Development and Technology, 2016
Orodispersible films have gained increasing relevance as a novel dosage form. Associated to their particular processing and multicomponent composition, there are a vast number of reasons to establish helpful development guidance, gathering simultaneously the recent pharmaceutical regulatory trends.This study aimed characterize marketed orodispersible ...
Ana Filipa, Borges, Cláudia, Silva, Jorge F J, Coelho, Sérgio, Simões   +3 more
openaire   +2 more sources

Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions

Journal of Drug Delivery Science and Technology, 2017
Abstract The aim of this study was to develop, characterize and evaluate concentrated nanoemulsions (20%) for parenteral nutrition. Those systems were developed by the high-pressure homogenization method. Optimal conditions for the nanoemulsion production were identified using 24-1 fractional factorial design.
Mirković, Dušica, Ibrić, Svetlana, Balanc, Bojana, Knez, Željko, Bugarski, Branko   +4 more
openaire   +4 more sources

Performance-Based Quality Specifications: The Relationship Between Process Critical Control Parameters, Critical Quality Attributes, and Clinical Performance

Journal of Pharmaceutical Sciences, 2011
The quality of pharmaceutical products is currently evaluated through a series of tests that do not explicitly communicate the clinical consequences of product variability. A previously published risk simulation platform was used to generate quantitative estimates of inefficacy and toxicity for 288 uniform lots of extended-release theophylline tablets ...
Steven M, Short, Robert P, Cogdill, James K, Drennen, Carl A, Anderson   +3 more
openaire   +2 more sources

A critical review of techniques for classifying quality attributes in the Kano model

Managing Service Quality: An International Journal, 2011
PurposeThe purpose of this paper is: to review the most commonly used approaches to the classification of quality attributes according to the Kano model; to identify the theoretical/practical strengths and weaknesses of these techniques; and to provide guidance for future research and managerial practice in this area.Design/methodology/approachBased on
Josip Mikulić, Darko Prebežac
openaire   +4 more sources

Security

Proceedings of the 13th International Conference on Software Engineering for Adaptive and Self-Managing Systems, 2018
Self-Adaptive Systems (SAS) are revolutionizing many aspects of our society. From server clusters to autonomous vehicles, SAS are becoming more ubiquitous and essential to our world. Security is frequently a priority for these systems as many SAS conduct mission-critical operations, or work with sensitive information.
Anthony Peruma, Daniel E. Krutz
openaire   +2 more sources

A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes

Statistics in Biopharmaceutical Research, 2018
ABSTRACTTo ensure the safety, efficacy, and quality, regulatory authorities require that multiple critical quality attributes of a drug must conform to certain specification limits.
Binbing Yu, Lingmin Zeng, Harry Yang
openaire   +1 more source

The Six Critical Attributes of the Next Generation of Quality Management Software Systems

Bioanalysis, 2011
Driven by both the need to meet regulatory requirements and a genuine desire to drive improved quality, quality management systems encompassing standard operating procedure, corrective and preventative actions and related processes have existed for many years, both in paper and electronic form.
openaire   +2 more sources