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Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations Mindy J. Allport-settle
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Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations
Mindy J. Allport-settle
Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling
| Mídia | Livros Paperback Book (Livro de capa flexível e brochura) |
| Lançado | 26 de agosto de 2010 |
| ISBN13 | 9780982147672 |
| Editoras | PharmaLogika |
| Páginas | 710 |
| Dimensões | 150 × 230 × 40 mm · 934 g |
| Idioma | Inglês |
