By J E Aguilar
These instruments can be utilized to higher observe the “Quality via layout” and “New procedure for approach Validation directions” to drugs improvement. this can be an incredibly topical topic, because the regulatory surroundings is altering and using preformulation instruments within the pharmaceutical can assist within the improvement of medications in keeping with caliber by means of layout and GMP with twenty first century principles.
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Extra info for Formulation tools for pharmaceutical development
Example text
As the purpose of modelling is to increase our understanding of a process, great efforts have been carried out within the pharmaceutical field to model different types of processes (Kremer and Hancock, 2006) and formulation behaviour (Siepmann and Siepmann, 2008). Mechanistic, empirical or semiempirical mathematical models, continuum or discrete models have been employed to understand the behaviour of formulations or process, to allow comparisons between them, to predict their properties or find the best procedure to formulate a dosage form (Gibson, 2009).
M. Landin Mariana Landin studied pharmacy at the University of Santiago de Compostela (Spain) and holds a doctorate from the same University (1991). After a three-year postdoctoral stage in the UK, she again joined the Department of Pharmacy and Pharmaceutical Technology at the University of Santiago, becoming a professor in 1998. Dr. Landin was recognized as a Specialist in Industrial Pharmacy by the Spanish Government in 2005. She has participated in a substantial number of basic and applied research projects, both national and international.
All these phases are strictly linked and require exchange of information in trying to understand the complex non-linear relationships between the formulation composition, process conditions, and product properties. This information is not only useful at the development stage, but also subsequently for identifying root causes and supporting implementation of effective corrective and preventive actions. The pharmaceutical development phase provides information critical to form the basis of process understanding.