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| 020 | _a9783030430733 | ||
| 024 | 7 |
_a10.1007/978-3-030-43073-3 _2doi |
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_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC |
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| 050 | 4 |
_aRM300 _b2020 EB |
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| 100 | 1 |
_aGad, Shayne C., _eautor _4http://id.loc.gov/vocabulary/relators/aut _1http://viaf.org/viaf/112203667 _9673163 _d1948- |
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| 245 | 1 | 0 |
_aContract Research and Development Organizations : _bTheir History, Selection, and Utilization _cby Shayne C. Gad, Charles B. Spainhour, David G. Serota |
| 250 | _aFirst edition | ||
| 264 | 1 |
_aCham _bImprint: Springer _c2020 |
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| 264 | 1 |
_aCham _bSpringer International Publishing _c2020 |
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| 300 |
_a1 recurso en línea (XIII, 519 páginas) _b19 ilustraciones, 1 ilustración a color |
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| 336 |
_2rdacontent _aTexto _btxt |
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| 337 |
_2rdamedia _aelectrónico _bc |
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| 338 |
_2rdacarrier _arecurso electrónico _bcr |
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| 347 |
_aArchivo de texto _bPDF |
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| 490 | 0 | _aBiomedical and Life Sciences (SpringerNature-11642) | |
| 490 | 0 | _aBiomedical and Life Sciences (R0) (SpringerNature-43708) | |
| 505 | 0 | _aIntroduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index. . | |
| 520 | _aThis volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements - SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs - where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities - and for auditing studies and projects at such facilities - are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update. | ||
| 988 | _aSpringer_Biomedlife_03082020 | ||
| 650 | 7 |
_2embne _aFarmacología _9137893 |
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| 650 | 7 |
_2embne _aToxicología _9140328 |
|
| 700 | 1 |
_aSpainhour, Charles B. _eautor _4http://id.loc.gov/vocabulary/relators/aut _0http://id.loc.gov/authorities/names/no2011142363 _1http://viaf.org/viaf/186213316 _9675404 |
|
| 700 | 1 |
_aSerota, David G. _eautor _4http://id.loc.gov/vocabulary/relators/aut _9675405 |
|
| 776 | 0 | 8 |
_iPrinted edition: _z9783030430726 |
| 776 | 0 | 8 |
_iPrinted edition: _z9783030430740 |
| 776 | 0 | 8 |
_iPrinted edition: _z9783030430757 |
| 856 | 4 | 0 |
_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-43073-3 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid) |
| 942 |
_2lcc _cLE |
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| 998 |
_b08/2020 _dz _ek _zSI |
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