Kooperativer Bibliotheksverbund

UID:

Format: 1 online resource (279 p.)

Edition: 1st ed.

ISBN: 0-12-803116-6

Content: 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

Note: Description based upon print version of record. , 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 , English

Additional Edition: ISBN 0-12-803115-8

Language: English