Results 171 to 180 of about 6,391 (215)

Implementation of QbD for the development of a vaccine candidate

Vaccine, 2014
This case study provides an example of how Quality by Design (QbD) principles were applied to accelerate process development to manufacture a vaccine candidate at commercial scale. By leveraging an existing manufacturing platform process, a risk assessment was used to differentiate process parameters that could be defined using a combination of ...
Jennifer, Haas, Andrew, Franklin, Matthew, Houser, David, Maraldo, Mark, Mikola, Roberto, Ortiz, Elizabeth, Sullivan, José M, Otero   +7 more
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A Review on: Quality by Design (QbD)

Asian Journal of Research in Pharmaceutical Science, 2017
Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design.
Vrushali R. Kadam, M. P. Patil, Vrushali V. Pawar, Sanjay Kshirsagar   +3 more
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The Evolution of Quality by Design (QbD) for Biologics

PDA Journal of Pharmaceutical Science and Technology, 2014
In recent years, regulators have recognized the need for more controls in drug manufacturing processes. Quality by design is a science- and risk-based approach to drug product development and several pilot programs are ongoing to evaluate enhanced drug development strategies.
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Numerical methods for QBD matrix equations

Computational and Applied Mathematics
zbMATH Open Web Interface contents unavailable due to conflicting licenses.
Jinrui Guan, Xiaolu Zhao, Ruiping Wen
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Solution of finite QBD processes

Journal of Applied Probability, 1996
We provide an explicit matrix analytic solution for finite quasi birth and death (QBD) processes, directly expressed in terms of process parameters. We show that this solution has the same asymptotic complexity of previously proposed non-explicit solutions and is more general than some of them.
de Nitto Personè, Vittoria, Grassi, Vincenzo   +1 more
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General QBD processes with applications to overload control

Proceedings IEEE INFOCOM 2000. Conference on Computer Communications. Nineteenth Annual Joint Conference of the IEEE Computer and Communications Societies (Cat. No.00CH37064), 2002
In this paper we introduce a general class of level-dependent quasi-birth-and-death (QBD) processes and their stationary solution. We obtain the complete characterization of their fundamental matrices in terms of minimal non-negative solution of the number of matrix quadratic equations. Our results provides a mixed-geometric solution for the stationary
Sung Ho Choi, Khosrow Sohraby, Bara Kim
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QbD Approach in Method Development

Research Journal of Pharmacy and Technology
The methodical strategy known as Quality by Design or QbD has transformed the pharmaceutical sector by emphasising product quality, safety, and efficacy. This method, which is supported by regulatory organisations such as the USFDA and ICH, emphasises the importance of risk management, understanding processes and goods, and predetermined targets ...
Aishwarya Reddy, Shikha Saxena
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Establishing a control system using QbD principles

Biologicals, 2016
Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product.
J Felix, Kepert, Mary, Cromwell, Niklas, Engler, Christof, Finkler, Gerald, Gellermann, Lynn, Gennaro, Reed, Harris, Raquel, Iverson, Brian, Kelley, Lynne, Krummen, Nathan, McKnight, Paul, Motchnik, Volker, Schnaible, Ron, Taticek   +13 more
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Geometric decay in level-expanding QBD models

Annals of Operations Research, 2007
zbMATH Open Web Interface contents unavailable due to conflicting licenses.
Liming Liu, Masakiyo Miyazawa, Yiqiang Q. Zhao   +2 more
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Busy period analysis of finite QBD processes

ACM SIGMETRICS Performance Evaluation Review, 2008
We present the number of customers served and the length of a busy period for finite quasi birth and death (QBD) processes where either one or both of the arrival or service processes can be serially correlated or interdependent. Special cases include the G/G/1/K, M/G/1/K, and G/M/1/K queues.
Chaitanya Garikiparthi, Appie van de Liefvoort, Kenneth Mitchell   +2 more
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