Quality by design is a systematic approach to drug product development and manufacturing that starts by defining the target product quality. It continues with an assessment of the risks to product quality that are involved in the characteristics of the raw materials and in the parameters of the manufacturing process. At the following stage, the actual impact of the characteristics and parameters identified is found through experiments and the design space is defined on that basis. Design space is an abstract multidimensional space in which the desired product quality can be attained by changing and controlling the variables. Based on the advanced knowledge of the product and the process obtained, the process can be optimized effectively and an appropriate control strategy set at points representing the greatest risk to quality or at points where information can be obtained well enough in advance to allow for reversing (by an appropriate adjustment of the process conditions) a potentially inappropriate course of the process. The information gained through the use of quality-by-design tools can then be used to accelerate the registration process of a new drug product and, in particular, for a substantial increase of manufacturing process efficiency and of the certainty that the desired product quality will be achieved.

• Keywords
• optimalizace, Quality by design,
• MeSH
• Drug Industry * methods   organization & administration   MeSH
• Risk Assessment MeSH
• Drug and Narcotic Control * organization & administration   MeSH
• Drug Compounding * MeSH
• Quality Control MeSH
• Guidelines as Topic MeSH
• Statistics as Topic MeSH
• Publication type
• Review MeSH

• Conspectus
• Farmacie. Farmakologie
• NML Fields
• farmacie a farmakologie

• MeSH
• Models, Psychological MeSH
• User-Computer Interface MeSH
• Space Perception MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH

• MeSH
• Statistics as Topic MeSH

• Conspectus
• Statistika
• NML Fields
• statistika, zdravotnická statistika

• MeSH
• Animal Experimentation MeSH
• Fibrinogen MeSH
• Hematocrit MeSH
• Hemodynamics MeSH
• Heart, Artificial mortality   MeSH

• MeSH
• Dibenzothiepins analogs & derivatives   chemical synthesis   MeSH
• Animal Experimentation MeSH
• Tranquilizing Agents chemical synthesis   MeSH

To assess the environmental fate of engineered nanoparticles (ENPs), it is essential to understand their interactions with dissolved organic matter (DOM). The highly complex nature of the interactions between DOM and ENPs and other particulate matter (PM) requires investigating a wide range of material types under different conditions. However, despite repeated calls for an increased diversity of the DOM and PM studied, researchers increasingly focus on certain subsets of DOM and PM. Considering the discrepancy between the calls for more diversity and the research actually carried out, we hypothesize that materials that were studied more often are more visible in the scientific literature and therefore are more likely to be studied again. To investigate the plausibility of this hypothesis, we developed an agent-based model simulating the material choice in the experiments studying the interaction between DOM and PM between 1990 and 2015. The model reproduces the temporal trends in the choice of materials as well as the main properties of a network that displays the DOM and PM types investigated experimentally. The results, which support the hypothesis of a positive reinforcing material choice, help to explain why calls to increase the diversity of the materials studied are repeatedly made and why recent criticism states that the selection of materials is unbalanced.

• MeSH
• Water Pollutants, Chemical analysis   MeSH
• Models, Chemical MeSH
• Humic Substances analysis   MeSH
• Environmental Monitoring methods   MeSH
• Nanoparticles MeSH
• Organic Chemicals analysis   MeSH
• Particulate Matter analysis   MeSH
• Computer Simulation MeSH
• Solubility MeSH
• Selection Bias * MeSH
• Research Design MeSH
• Bias * MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

• MeSH
• Electric Stimulation instrumentation   MeSH
• Facial Paralysis MeSH
• Taste Disorders diagnosis   MeSH
• Publication type
• Comparative Study MeSH

• MeSH
• Equipment Design * MeSH
• Diabetes Mellitus MeSH
• Blood Glucose analysis   MeSH
• Humans MeSH
• Mobile Applications MeSH
• Blood Glucose Self-Monitoring * methods   instrumentation   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH

• MeSH
• Clinical Trials as Topic methods   MeSH
• Mathematics MeSH
• Statistics as Topic MeSH
• Publication type
• Monograph MeSH

• Conspectus
• Lékařské vědy. Lékařství
• NML Fields
• lékařství