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008			230713s2023 sz | o |||| 0|eng d
020			_a9783031315053
024	7		_a10.1007/978-3-031-31505-3 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRS420 _b2023 EB
245	0	0	_aIntroduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development _cedited by Márcia Cristina Breitkreitz, Hector Goicoechea
250			_a1st ed. 2023
264		1	_aCham _bSpringer International Publishing _c2023
300			_a1 recurso en línea
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	0		_aAAPS Introductions in the Pharmaceutical Sciences _x2522-8358 _v10
505	0		_aPart 1: Quality by Design (QbD) -- Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements -- Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology -- Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology -- Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology -- Chapter 5. Quality by Design in pharmaceutical product and process development -- Chapter 6. A Quality by Design update on nano-drug delivery systems -- Chapter 7. Control strategies of solid dosage forms by PAT tools -- Part 2: Analytical Quality by Design (AQbD) -- Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives -- Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR) -- Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals -- Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds. .
520			_aWritten by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.
988			_aSpringer_BiomedLife_2023
650		7	_2embne _9395061 _aMedicamentos _xDiseño
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-31505-3 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b04/2024 _dz _eb _zSI