| Description |
1 online resource |
| Contents |
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 |
| Summary |
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 that should be used in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond, bridging the gap in knowledge with the inclusion of examples of design of GLP-compliant preclinical studies, design of bioprocesses for autologous/allogeneic thera |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Online resource; title from PDF title page (EBSCO, viewed July 29, 2015) |
| Subject |
Cellular therapy.
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Blood -- Transfusion, Autologous -- Treatment
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Medical care -- Quality control.
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Cell- and Tissue-Based Therapy -- standards
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Cell- and Tissue-Based Therapy
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Clinical Trials as Topic
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Quality Assurance, Health Care
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HEALTH & FITNESS -- Diseases -- General.
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MEDICAL -- Clinical Medicine.
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MEDICAL -- Diseases.
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MEDICAL -- Evidence-Based Medicine.
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MEDICAL -- Internal Medicine.
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Medical care -- Quality control
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Cellular therapy
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| Form |
Electronic book
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| Author |
Vives, Joaquim, editor
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Carmona, Gloria (Pharmacist), editor.
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| ISBN |
9780128031162 |
|
0128031166 |
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