000			04143nam a2200433 c 4500
988			_aSpringer_BiomedLife_2019
999			_c115779 _d115779 _x1
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005			20230110040237.0
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008			190807s2019 gw | s |||| 0|eng d
020			_a9783030173555
024	7		_a10.1007/978-3-030-17355-5 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRM301.25 _b2019 EB
245	1	4	_aThe Role of Microstructure in Topical Drug Product Development _cedited by Nigel Langley, Bozena Michniak-Kohn, David W. Osborne.
250			_a1st ed. 2019.
264		1	_aCham, Switzerland _bSpringer International Publishing _c2019
300			_a1 recurso en línea (XIV, 199 páginas) _b102 ilustraciones, 57 ilustraciones a color
336			_aTexto _btxt _2rdacontent
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_atext file _bPDF
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v36
490	0		_aBiomedical and Life Sciences (Springer-11642)
505	0		_aPart I - Critical Quality Attributes: 1. Rheological Characterization in the Development of Topical Drug Products -- 2. In Vitro Release & Permeation Tests as Critical Quality Attributes in Topical Product Development -- 3. Determination of Particle Size and Microstructure in Topical Pharmaceuticals -- Part II - Role of API and Excipients: 4. Quality Assessment of API in Semisolid Topical Drug Products -- 5. The Role of Excipients in the Microstructure of Topical Semi-solid Drug Products.
520	3		_aFollowing the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content. Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas. .
650		7	_aMedicamentos _9137892 _2embne
700	1		_aLangley, Nigel _eeditor _4edt _4http://id.loc.gov/vocabulary/relators/edt _984875
700	1		_aMichniak-Kohn, Bozena _eeditor _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aOsborne, David W _eeditor _4edt _4http://id.loc.gov/vocabulary/relators/edt
776	0	8	_iPrinted edition: _z9783030173548
776	0	8	_iPrinted edition: _z9783030173562
776	0	8	_iPrinted edition: _z9783030173579
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-17355-5 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_aSI _cm _dz _feng _ggw _h0 _b12/2019 _ea _zSI