LEADER 04481nam 2200613 450 001 9910806271003321 005 20200520144314.0 010 $a0-12-803116-6 035 $a(CKB)3710000000450658 035 $a(EBL)2110663 035 $a(SSID)ssj0001562336 035 $a(PQKBManifestationID)16206104 035 $a(PQKBTitleCode)TC0001562336 035 $a(PQKBWorkID)14833755 035 $a(PQKB)11013178 035 $a(MiAaPQ)EBC2110663 035 $a(Au-PeEL)EBL2110663 035 $a(CaPaEBR)ebr11081656 035 $a(CaONFJC)MIL822709 035 $a(OCoLC)915311598 035 $a(PPN)192176870 035 $a(EXLCZ)993710000000450658 100 $a20150804h20162016 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aGuide to cell therapy GxP $equality standards in the development of cell-based medicines in non-pharmaceutical environments /$fJoaquim Vives, Gloria Carmona 210 1$aAmsterdam, Netherlands :$cAcademic Press,$d2016. 210 4$dİ2016 215 $a1 online resource (279 p.) 300 $aDescription based upon print version of record. 311 $a0-12-803115-8 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aFront 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 327 $a1. 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 327 $a5. 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 327 $a6 - 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 330 $a 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 606 $aCellular therapy 606 $aBlood$xTransfusion, Autologous$xTreatment 615 0$aCellular therapy. 615 0$aBlood$xTransfusion, Autologous$xTreatment. 676 $a616.0277 700 $aVives$b Joaquim$01676881 702 $aCarmona$b Gloria 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910806271003321 996 $aGuide to cell therapy GxP$94043368 997 $aUNINA