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040			_aES-MaUEC _bspa _cES-MaUEC
336			_aTexto _btxt _2rdacontent
988			_aSpringerBiomedLife_2019
999			_c109261 _d109261 _x1
001			109261
005			20230110040217.0
008			190423s2019 gw | o |||| 0|eng d
020			_a9783030117511
024	7		_a10.1007/978-3-030-11751-1 _2doi
050		4	_aRS380 _b2019 EB
245	0	4	_aThe Science and Regulations of Naturally Derived Complex Drugs _cedited by Ram Sasisekharan, Sau L. Lee, Amy Rosenberg, Larry A. Walker.
264		1	_aCham, Switzerland _bSpringer International Publishing _c2019
300			_a1 recurso en línea (VI, 331 páginas) _b61 ilustraciones, 41 ilustraciones a color
337			_aelectrónico _bc
338			_arecurso electrónico _bcr
347			_atext file _bPDF
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v32
490	0		_aBiomedical and Life Sciences (Springer-11642)
505	0		_aEvolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective -- Regulatory Landscapes for Approval of Naturally-derived Complex Mixture Drugs -- Complex Natural Product Heparin: Biosynthesis, Biology and Application via Synthetic Heparins -- Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments -- Analytics on Farm-Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease -- Analytical Tools for Physicochemical Characterization and Fingerprinting -- NMR in the Characterization of Complex Mixture Drugs -- Mass Spectrometry in the Characterization of Complex Drugs -- Scientific Considerations in the Approval of Complex Generi -- Raw Materials Production and Manufacturing Process Control Strategies -- Heparin Contamination and Issues Related to Raw Materials and Controls -- Pharmacology and Toxicology Concerns of Impurities -- Immunogenicity risks for Naturally Derived Complex Drugs -- Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations -- A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures -- Economic Considerations for Complex Mixture Drugs -- Drug Discovery from Complex Mixtures: Serendipity, Screening and Characterization -- Integrated Approach for Characterization of Highly Heterogeneous Drugs. .
520	3		_aThis volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.
650		7	_2embne _9155839 _aBiotecnología farmacéutica
700	1		_aLee, Sau L. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aRosenberg, Amy. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt _993499
700	1		_aSasisekharan, Ram. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aWalker, Larry A. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
776	0	8	_iPrinted edition: _z9783030117504
776	0	8	_iPrinted edition: _z9783030117528
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi-org/10.1007/978-3-030-11751-1 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_aSI _cm _dz _feng _ggw _h0 _b07/2019 _ek _zSI