Guide to Cell Therapy GxP

• Author : Joaquim Vives,Gloria Carmona
• Publisher : Academic Press
• Release : 24 July 2015

Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on

• Author : Christopher M. Hayre,Xiaoming Zheng
• Publisher : CRC Press
• Release : 28 September 2021

This book provides an holistic picture of the application of research in radiography and focuses on multivariant methodological approaches and practices. It will provide readers insight into both contemporary and innovative methods within radiography research, backed up with evidence-based literature. This book may also be translated into other health disciplines as it introduces research to the reader by detailing terms that can often be confusing for students. These remain central in understanding the importance of research in radiography and how

• Author : Jorge S. Burns
• Publisher : Springer Nature
• Release : 02 July 2023

This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various

• Author : Mahmoud Aljurf,John A. Snowden,Patrick Hayden,Kim H. Orchard,Eoin McGrath
• Publisher : Springer Nature
• Release : 19 February 2021

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management

• Author : Hans-Dieter Volk,Annelise Bennaceur Griscelli,Manuela Battaglia,Nuno M. Neves
• Publisher : Frontiers Media SA
• Release : 30 November 2022

• Author : William J. Brock,Barbara Mounho,Lijie Fu
• Publisher : John Wiley & Sons
• Release : 03 June 2014

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal

• Author : Kenichiro Yagi,Marie Holowaychuk
• Publisher : John Wiley & Sons
• Release : 06 September 2016

Using a practical approach, the Manual of Veterinary Transfusion Medicine and Blood Banking provides veterinary practitioners with evidence-based guidelines to refer to at the clinical practice level. Provides evidence-based information on transfusion medicine and blood banking practices Presents sections on recipient screening, donor selection, blood collection and storage, and how to meet blood product demands Includes useful protocols for transfusions and blood banking relevant to clinical practice Incorporates the balanced perspectives of veterinarians and veterinary technicians Contains information pertaining to

• Author : Anonim
• Publisher : Unknown
• Release : 03 June 2023

• Author : Anonim
• Publisher : Unknown
• Release : 03 June 2023