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001			393792
003			ES-MaUEC
005			20230102123029.0
007			cr nn 008mamaa
008			220823s2022 sz | s |||| 0|eng d
020			_a9783030971939
024	7		_a10.1007/978-3-030-97193-9 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC
245	1	3	_aAn Introduction to Bioanalysis of Biopharmaceuticals _cedited by Seema Kumar
250			_a1st edition 2022
264		1	_aCham _bSpringer International Publishing _c2022
300			_a1 recurso en línea (IX, 160 páginas) _b25 ilustraciones, 19 ilustraciones a color
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
347			_aarchivo de texto _bPDF
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-738X _v57
505	0		_aBioanalytical Support in Drug Discovery and Development,- Monoclonal Antibodies -- Antibody Drug Conjugates (ADCS) -- Bispecifics and Fusion Proteins -- Emerging Modalities-Part A- (Gene Therapy and Cell Therapy) -- Emerging Modalities Part B (Peptides, Oligonucleotide Based Therapy, Vaccines. .
520			_aThe book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.
700	1		_aKumar, Seema _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
776	0	8	_iPrinted edition: _z9783030971922
776	0	8	_iPrinted edition: _z9783030971946
776	0	8	_iPrinted edition: _z9783030999988
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-97193-9 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
988			_aSpringer_BiomedLife_2022
999			_c393792 _d393792