Guide to cell therapy GxP : quality standards in the development of cell-based medicines in non-pharmaceutical environments /

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Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments provides a practical guide to the implementation of quality assurance systems for successful performance of all cell-based clinical trials. The book includes all information tha...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Vives, Joaquim (Editor ), Carmona, Gloria (Pharmacist) (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Amsterdam : Elsevier, 2016.
Temas:
Cellular therapy.
Blood > Transfusion, Autologous > Treatment.
Medical care > Quality control.
Cell- and Tissue-Based Therapy > standards
Cell- and Tissue-Based Therapy
Clinical Trials as Topic
Quality Assurance, Health Care
Thérapie cellulaire.
Sang > Autotransfusion > Traitement.
Soins médicaux > Qualité > Contrôle.
HEALTH & FITNESS > Diseases > General.
MEDICAL > Clinical Medicine.
MEDICAL > Diseases.
MEDICAL > Evidence-Based Medicine.
MEDICAL > Internal Medicine.
Medical care > Quality control
Cellular therapy
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Overview of the Development Program of a Cell-Based Medicine
  • 1. Introduction
  • 2. Key Pharmaceutical Factors to Consider in Early Development Stages
  • 3. TPP: Beginning with the End in Mind
  • 4. Stages of Drug Development
  • 5. Considering Stakeholders
  • 6. Product Lifecycle and Portfolio Management
  • 7. Performance Management and the Check Point Value
  • 8. Conclusions
  • References
  • Glossary
  • List of Acronyms and Abbreviations
  • European Regulatory Framework for the Development of Cell-Based Medicines
  • 1. Introduction
  • 2. What Cell-Based Products are Considered as Medicinal Products? The Legal Definitions and Main Regulations Applying to Cell-Based Products
  • 3. An Introduction to Cell-Based Medicine Development: Roadmap
  • 4. Regional and National Institutions Supporting Cell Therapy Translational Research
  • 5. European Regulation for Advanced Therapy Medicinal Products Not Intended to be Placed on the Market: Hospital Exemption and Its National Interpretation
  • 6. Conclusions
  • References
  • Nonclinical Studies for Cell-Based Medicines
  • 1. Introduction
  • 2. Types of Cell-Based Advanced Therapy Medicinal Products and their Safety Considerations
  • 3. Regulations and Nonclinical Studies
  • 4. Nonclinical Assessment-The Risk-Based Approach
  • 5. The Requirement for Good Laboratory Practice
  • 6. General Study Design Considerations
  • 7. Specific Nonclinical Safety Considerations
  • 8. Conclusions
  • References
  • Glossary
  • List of Acronyms and Abbreviations
  • Good Manufacturing Practice Compliance in the Manufacture of Cell-Based Medicines
  • 1 . Outline of the Chapter
  • 2. Quality Management
  • 3. Documentation
  • 4. Qualification and Validation
  • 5. Premises and Equipment
  • 6. Personnel and Hygiene
  • 7. Manufacturing
  • 8. Quality Control
  • 9. Inspections, Audits, Complaints, Recalls, and Returns
  • 10. Conclusion
  • Acknowledgment
  • References
  • List of Abbreviations
  • Good Clinical Practice in Nonprofit Institutions
  • 1. Introduction
  • 2. The Elements of GCP Compliance
  • 3. The Clinical Trial Protocol
  • 4. The Investigator's Brochure
  • 5. The Informed Consent
  • 6. Essential Documents for Clinical Trial
  • 7. Clinical Trial Files
  • 8. Sponsor' Study Audit and Inspections
  • 9. Conclusion
  • References
  • Glossary
  • List of Acronyms and Abbreviations
  • Compatibility of GxP with Existing Cell Therapy Quality Standards
  • 1. Quality Standards in Cell Therapy
  • 2. Adaptation of Existing Standards to GxP
  • 3. Impact of GxP Implementation
  • 4. Quality by Design
  • 5. Recommendations for Optimizing Integration of QA Systems
  • 6. Conclusions
  • References
  • Glossary
  • List of Abbreviations

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