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Nonclinical Safety Assessment : a Guide to International Pharmaceutical Regulations.
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach....
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
Wiley,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations; Contents; List of Contributors; Preface; Part I: International Regulations and Nonclinical Studies for Pharmaceuticals; 1 Introduction; 1.1 The Global Pharmaceutical Market; 1.2 Looking to the Future; 1.3 Legal and Regulatory Considerations in Drug Development; 1.4 The Drug Development Process
- General Considerations; References; 2 ICH: History and Nonclinical Guidances; 2.1 Introduction; 2.2 Organization of the ICH; 2.3 The ICH Process; 2.4 Animal Welfare and Alternative Methods; 2.5 ICH M3.
- 2.6 New Initiatives and TopicsReferences; 3 Food and Drug Administration: Nonclinical Program and Pharmaceutical Approval; 3.1 Legislative Authority of the FDA; 3.2 Nonclinical Drug Development and the FDA; 3.3 Nonclinical Testing: General Conditions and Considerations; 3.4 Toxicity Testing: Small Molecules and Traditional Pharmaceuticals; 3.5 Toxicity Testing of Pharmaceuticals
- The General Approach; 3.6 First-in-Human Dosing: Results from Nonclinical Studies; References; 4 Nonclinical Pharmaceutical Development in MERCOSUR and Brazil; 4.1 Introduction; 4.2 MERCOSUR; 4.3 Brazil.
- 4.3.1 Brazilian Regulatory Aspects4.3.2 Nonclinical Studies Required for Drug Registration; 4.3.3 Comparison with Other Agencies and Harmonization Institutes; 4.3.4 Regional Reality of Drug Registration
- Final Comments; References; 5 Nonclinical Safety Assessment: Canada; 5.1 Introduction; 5.2 Organization of Health Canada; 5.2.1 Therapeutic Products Directorate; 5.2.2 Biologics and Genetic Therapies Directorate; 5.2.3 Natural Health Products Directorate; 5.3 The Regulatory Framework for Drug Approval in Canada; 5.3.1 The Food and Drugs Act; 5.3.2 The Food and Drug Regulations.
- 5.4 Nonclinical Assessment in Canada5.4.1 Canada and the International Conference on Harmonization; 5.4.2 Good Laboratory Practices in Canada; 5.4.3 Case Studies and Summary Basis of Decision; 5.5 Clinical Trial Applications; 5.5.1 History and Regulations; 5.5.2 Clinical Trial Application Overview; 5.5.3 Pre-Submission Meetings and Consultations; 5.5.4 CTA Content and Format; 5.5.5 Nonclinical Aspects of the CTA/CTA-A Process; 5.5.6 CTA-A Content and Format; 5.5.7 CTA and CTA-A Review Process; 5.6 Special Regulatory Considerations; 5.6.1 Generic Drugs.
- 5.6.2 Subsequent Entry Biologics in Canada5.6.3 Orphan Drugs in Canada; References; 6 European Pharmaceutical Regulation
- Nonclinical Testing Requirements; 6.1 Introduction; 6.1.1 Definitions; 6.2 Regulation of Medicinal Products in the European Union; 6.2.1 Overview; 6.2.2 Role of the European Medicines Agency in the Regulation of Medicines; 6.2.3 Scientific Structure of the EMA; 6.2.4 Regulatory Process in the EU; 6.3 Nonclinical Testing in the Support of Clinical Trials; 6.3.1 Role of Individual Country Regulatory Agencies/Authorities.