Application of Quality by Design Principles for the Definition of a Robust Crystallization Process for Casopitant Mesylate

AbstractThe advent of additive manufacturing (AM) in recent years have had a significant impact on the design process. Because of new manufacturing technology, a new area of research emerged – Design for Additive Manufacturing (DfAM) with newly developed design support methods and tools. This paper looks into the current status of the field regarding the conceptual design of AM products, with the focus on how literature sources treat design heuristics and design principles in the context of DfAM. To answer the research question, a systematic literature review was conducted. The results are analysed, compared and discussed on three main points: the definition of the design heuristics and the design principles, level of support they provide, as well as where and how they are used inside the design process. The paper highlights the similarities and differences between design heuristics and design principles in the context of DfAM.

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Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Biologicals ◽

10.1016/j.biologicals.2016.06.005 ◽

2016 ◽

Vol 44 (5) ◽

pp. 291-305 ◽

Cited By ~ 77

Author(s):

Nadja Alt ◽

Taylor Y. Zhang ◽

Paul Motchnik ◽

Ron Taticek ◽

Valerie Quarmby ◽

...

Keyword(s):

Monoclonal Antibodies ◽

Quality By Design ◽

Design Principles ◽

Quality Attributes ◽

Critical Quality Attributes

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A workflow for column interchangeability in liquid chromatography using modeling software and quality-by-design principles

Journal of Pharmaceutical and Biomedical Analysis ◽

10.1016/j.jpba.2017.08.032 ◽

2017 ◽

Vol 146 ◽

pp. 220-225 ◽

Cited By ~ 9

Author(s):

Róbert Kormány ◽

Katalin Tamás ◽

Davy Guillarme ◽

Szabolcs Fekete

Keyword(s):

Liquid Chromatography ◽

Quality By Design ◽

Design Principles ◽

Modeling Software

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Lean & Green on Industry 4.0 Context – Contribution to Understand L&G Drivers and Design Principles

International Journal of Mathematical Engineering and Management Sciences ◽

10.33889/ijmems.2021.6.5.073 ◽

2021 ◽

Vol 6 (5) ◽

pp. 1214-1229

Author(s):

Lenin John ◽

Manuel Sampayo ◽

Paulo Peças

Keyword(s):

Industry 4.0 ◽

Research Work ◽

Design Principles ◽

Manufacturing Companies ◽

Bottom Line ◽

Industrial Firms ◽

Systems Implementation ◽

Sustainability Concept ◽

Proper Definition ◽

Definition Of

The purpose of this paper is to demonstrate how the implementation of Lean & Green (L&G) in an Industry 4.0 (I4.0) environment can enhance the potential impact of the L&G approach and help manufacturing companies moving towards higher operational and sustainable performances. The research work developed here shows that although a proper definition of L&G is neither exposed worldwide nor explicitly implemented under that name, the current industrial firms are deeply concerned about the demanding challenge of keeping businesses flexible and agile without forgetting strategies to minimize the acceleration of climate change. So, one contribution of this paper is the identification and characterization of L&G drivers and design principles, supporting a robust and well-informed L&G systems implementation. As inferred from the research work, this challenge demands high quality and updated data together with assertive information. Thus, the implementation of L&G in I4.0 contexts is the answer to overcome the identified barriers. Likewise, an L&G system contributes to overcoming the challenges of I4.0 implementation regarding the triple bottom line sustainability concept. Consequently, another contribution of this paper is to depict why an L&G system performs better in the I4.0 context.

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Using Quality by Design Principles as a Guide for Designing a Process Control Strategy

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture ◽

10.1002/9781119356189.ch7 ◽

2017 ◽

pp. 125-191

Author(s):

Christopher L. Burcham ◽

Mark LaPack ◽

Joseph R. Martinelli ◽

Neil McCracken

Keyword(s):

Process Control ◽

Control Strategy ◽

Quality By Design ◽

Design Principles

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Implementation of Quality by Design principles for the evolution of optimized sustained release drug delivery system

Drug Delivery Letters ◽

10.2174/2210303111666210421121812 ◽

2021 ◽

Vol 11 ◽

Author(s):

Lalit Singh ◽

Vijay Sharma

Keyword(s):

Mathematical Model ◽

Drug Delivery ◽

Sustained Release ◽

Drug Delivery System ◽

Delivery System ◽

Dosage Form ◽

Quality By Design ◽

Design Principles ◽

Release Drug

Aim: Aim of the present work is implementation of Quality by Design principles for the evolution of optimized sustained release drug delivery system Background: Quality by Design (QbD) approach refers to an advance approach to develop a optimized dosage form.QbD has become a vital modern scientific approach to develop a quality dosage form.In modern era of science researcher can develop a optimized dosage form with least effort, money and manpower. Objectives: Objective of research work wasthe successful development of optimized floating bioadhesive tablets of glipizide using floating-bioadhesive potential of cellulosic polymer and carbomersusing quality by design (QbD) approach. Method: Quality Target Product Profile (QTPP) of drug delivery system was defined as well as critical quality attributes (CQAs) were identified. A face centered central composite design (CCD) was utilized in assessing the impact of individual critical material attribute (CMA) like Hydro Propyl Methyl Cellulose K4M(HPMC K4M)and Carbopol 934P (CP 934P) and their interactions, using least experimentation. Formulations were developed and quantitative impact on CQAs was determined using mathematical model. The optimized formulation was obtained and characterized for in-vitro as well as in-vivo parameters. Results: A Fishikawa diagram and Failure Mode and Effect Analysis (FMEA) were performed to identify potential failure modes associated with the dosage form. The optimum formulation was embarked upon using mathematical model developed yielding desired CQAs followed for confirmation of data. Sustained release drug delivery system was successfully developed by using QbD approach. In-vivo X-ray imaging in rabbit and γ-scintigraphic study in manconfirmed the buoyant nature of the mucoadhesive floating tablet for 8 h in the upper gastrointestinal tract. Conclusion: Optimized formulation shows phenomenal floating, bioadhesive properties and drug release retardation characteristics, utilizing a mixture of cost-effective polymers Hence, QbD approach may be regarded as an important tool in development of floating bioadhesive CR dosage forms.

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Usability

Encyclopedia of Distance Learning ◽

10.4018/978-1-59140-555-9.ch294 ◽

2011 ◽

pp. 1931-1937

Author(s):

Su-Ting Yong

Keyword(s):

User Interface ◽

User Experience ◽

Interaction Design ◽

Design Principles ◽

Learning Program ◽

Design Models ◽

Computer Based Learning ◽

History Of ◽

Computer Based ◽

Definition Of

This is a brief review of the history of usability and a discussion of usability in developing a computer-based learning program (CBLP). According to ISO 9241, usability is defined as the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use (Bevan, 2001). The main focus of usability in this article is concerned with the user interface and interaction design. To create a usable computer-based learning program, one needs to understand the definition of usability and the goals of usability. Besides achieving usability goals, a usable CBLP should also be able to attain user experience goals. Design principles can be used to develop a CBLP featured with usability. Two design models will be discussed in this review.

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