Quality by Design: Development of Safe and Efficacious Full-Thickness Acellular Dermal Matrix Based on EuroGTPII Methodologies

• Published in: Therapeutics and clinical risk management Vol. 19; pp. 567 - 578
• Main Authors: López-Chicón, Patricia, Pérez, Maria Luisa, Castells-Sala, Cristina, Piteira, Ana Rita, Fariñas, Oscar, Tabera, Jaime, Vilarrodona, Anna
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2023; Dove; Dove Medical Press
• Subjects: acellular dermis; Analysis; eurogtpii methodology; Mechanical properties; Medical research; Medicine, Experimental; Methodology; Methods; quality; Risk assessment; safety; Spain; EuroGTPII methodology; risk assessment; acellular dermis; safety; quality

The activities of tissue establishments are constantly and rapidly evolving. The development of a new type of allograft, full-thickness acellular dermal matrix, with high mechanical properties to be used in tendon repair surgeries and abdominal wall reconstruction, has determined the need for qualit...