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Quality by Design for Nanocarriers
Published in Carla Vitorino, Andreia Jorge, Alberto Pais, Nanoparticles for Brain Drug Delivery, 2021
Branca M. A. Silva, Cláudia Silva
The ICH Q8 defines the design space as ‘the multidimensional combination and interaction of input variables (e. g. material attributes) and process parameters that have been demonstrated to provide assurance of quality’ [9]. The data obtained in the DoE is used to estimate each CQA (dimension) through statistical modelling. The prediction profiles obtained for each CQA (dimension) can be combined to find the region where the product meets the QTPP. The ranges/levels studied (characterisation range) in the DoE experiments represent the knowledge space while with the design space is possible to find the acceptable working range and the operating range (Fig. 11.5) [4, 5, 9, 43].
Food and Nutrition Innovation in the Context of Indigenous Knowledge Systems
Published in David R. Katerere, Wendy Applequist, Oluwaseyi M. Aboyade, Chamunorwa Togo, Traditional and Indigenous Knowledge for the Modern Era, 2019
The case studies represent four workshops that were organized on the premise that small-scale entrepreneurs, would-be entrepreneurs, or holders of indigenous knowledge have limited access to training and market information that they can use holistically to successfully participate in value chain development in the food and nutrition sector. The goal was to develop a knowledge space in a spirit of co-creation, where participants brought with them their own existing and indigenous knowledge. Furthermore, expertise from the region on specific issues (business development, marketing, legal issues, etc.) was introduced to enhance the co-creation process through dialogue, interaction, transparency, and understanding of risks and benefits in food and nutrition innovation. Having a higher education institution in the driver’s seat has relevancy due to the multiple roles that it can take on. These include economic acceleration by fostering a culture of entrepreneurship relevant to solving global societal challenges through interdisciplinary work, collaboration with the world of work which helps foster research and information exchange within and outside academia, and promotion of both diversity and inclusion. While disruption of economies continues to occur, higher education institutions can remain as strong foundations and guardians of knowledge economies, propelling the development of society.
Hard Shell Capsules in Clinical Trials
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Moji Christianah Adeyeye, Amusa Adebayo
The degree to which a variable is known in relation to its potential impact on process or product performance will enable its progression from knowledge space through design space to the specification (normal operating ranges) space (Figure 3.24). Ulmschneider [120] proposed a decision tree to determine degree of criticality and Zhang et al. investigated the applicability of a physiologically based absorption model to QbD in drug development [122]. An identical classical particle dissolution equation was observed for immediate-release suspensions, capsules, and tablets. However, tablets require longer transit time and the effect of food was formulation-dependent.
Optimization of nanovesicular carriers of a poorly soluble drug using factorial design methodology and artificial neural network by applying quality by design approach
Published in Pharmaceutical Development and Technology, 2021
Marwa H. S. Dawoud, Ahmed M. Fayez, Reem A. Mohamed, Nabila M. Sweed
Quality Target Product Profile (QTPP) is defined by the ICH Q8 (R2) as ‘a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product’ (ICH Expert Working Group 2009). In this study, the QTPP was to enhance the solubility of a poorly soluble drug, to enhance its bioavailability. Thus, literature reviews and pre-formulation studies were conducted to establish the knowledge space of the study components. Accordingly, the average PS, PDI, ζ-pot, EE%, and drug release profile may be considered as the most influential parameters which characterize the nanovesicular drug delivery systems and thus may be considered as the influential critical quality attributes (CQA) in this study (Xu et al. 2012).
Quality-by-design approach for the development of telmisartan potassium tablets
Published in Drug Development and Industrial Pharmacy, 2018
Ga-Hui Oh, Jin-Hyun Park, Hye-Won Shin, Joo-Eun Kim, Young-Joon Park
The knowledge space area, which was derived from the preliminary studies of the kneading time (X3), was in the range of 3.0–7.0 min. However, the range of kneading time that satisfied the target values of the five individual reaction values was in the range of 3.5 to 6.0 min, but it differed from the actual usage range. Therefore, the control space area must be between 4.0 and 5.5 min, considering the dissolution and impurities.