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Contract Research and Development Organizations-Their History, Selection, and Utilization / / by Shayne C. Gad, Charles B. Spainhour, David G. Serota
| Contract Research and Development Organizations-Their History, Selection, and Utilization / / by Shayne C. Gad, Charles B. Spainhour, David G. Serota |
| Autore | Gad Shayne C |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 |
| Descrizione fisica | 1 online resource (XIII, 519 p. 19 illus., 1 illus. in color.) |
| Disciplina | 658.57 |
| Soggetto topico |
Pharmacology
Pharmacy Pharmacology/Toxicology Literatura científica Investigació Contractes de recerca i desenvolupament |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-030-43073-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction -- 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. . |
| Record Nr. | UNINA-9910416106103321 |
Gad Shayne C
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Integrated Safety and Risk Assessment for Medical Devices and Combination Products / / by Shayne C. Gad
| Integrated Safety and Risk Assessment for Medical Devices and Combination Products / / by Shayne C. Gad |
| Autore | Gad Shayne C |
| Edizione | [1st ed. 2019.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 |
| Descrizione fisica | 1 online resource (XIII, 490 p. 26 illus., 6 illus. in color.) |
| Disciplina |
681.761
681.7610289 |
| Soggetto topico |
Pharmacology
Pharmacology/Toxicology |
| ISBN | 3-030-35241-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Introduction – History and Where We are Headed -- 2. Regulatory Guidance -- 3. Sample Preparation and Biocompatibility Testing -- 4. Testing for Leachables and Extractables -- 5. Where the Data is – And What is It? -- 6. Bridging Issues of Route -- 7. Risk Assessments for Medical Devices -- 8. (Q)SAR -- 9. Histopathology in Medical Device Studies -- 10. Assessment of Nanomaterial Devices -- 11. Integrated Safety Assessments for Devices -- 12. Toxicity of Common Extractables and Leachables. |
| Record Nr. | UNINA-9910377827903321 |
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Gad Shayne C
|
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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