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Guide to cell therapy GxP : quality standards in the development of cell-based medicines in non-pharmaceutical environments / / Joaquim Vives, Gloria Carmona
| Guide to cell therapy GxP : quality standards in the development of cell-based medicines in non-pharmaceutical environments / / Joaquim Vives, Gloria Carmona |
| Autore | Vives Joaquim |
| Pubbl/distr/stampa | Amsterdam, Netherlands : , : Academic Press, , 2016 |
| Descrizione fisica | 1 online resource (279 p.) |
| Disciplina | 616.0277 |
| Soggetto topico |
Cellular therapy
Blood - Transfusion, Autologous - Treatment |
| ISBN | 0-12-803116-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Guide to Cell Therapy GxP; Copyright; Contents; List of Contributors; Foreword; Preface; 1 - 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
1. Introduction2. 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; 4 - 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 Equipment6. Personnel and Hygiene; 7. Manufacturing; 8. Quality Control; 9. Inspections, Audits, Complaints, Recalls, and Returns; 10. Conclusion; Acknowledgment; References; List of Abbreviations; 5 - 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 6 - Compatibility of GxP with Existing Cell Therapy Quality Standards1. 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; Index |
| Record Nr. | UNINA-9910797368903321 |
Vives Joaquim
|
||
| Amsterdam, Netherlands : , : Academic Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guide to cell therapy GxP : quality standards in the development of cell-based medicines in non-pharmaceutical environments / / Joaquim Vives, Gloria Carmona
| Guide to cell therapy GxP : quality standards in the development of cell-based medicines in non-pharmaceutical environments / / Joaquim Vives, Gloria Carmona |
| Autore | Vives Joaquim |
| Pubbl/distr/stampa | Amsterdam, Netherlands : , : Academic Press, , 2016 |
| Descrizione fisica | 1 online resource (279 p.) |
| Disciplina | 616.0277 |
| Soggetto topico |
Cellular therapy
Blood - Transfusion, Autologous - Treatment |
| ISBN | 0-12-803116-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Guide to Cell Therapy GxP; Copyright; Contents; List of Contributors; Foreword; Preface; 1 - 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
1. Introduction2. 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; 4 - 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 Equipment6. Personnel and Hygiene; 7. Manufacturing; 8. Quality Control; 9. Inspections, Audits, Complaints, Recalls, and Returns; 10. Conclusion; Acknowledgment; References; List of Abbreviations; 5 - 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 6 - Compatibility of GxP with Existing Cell Therapy Quality Standards1. 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; Index |
| Record Nr. | UNINA-9910806271003321 |
|
Vives Joaquim
|
||
| Amsterdam, Netherlands : , : Academic Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||