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

Author:

López-Chicón Patricia,Pérez Maria Luisa,Castells-Sala Cristina,Piteria Rita A,Fariñas Oscar,Tabera Jaime,Vilarrodona Anna

Publisher

Informa UK Limited

Subject

Chemical Health and Safety,Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,Safety Research,General Medicine

Reference32 articles.

1. EDQM; Council of Europe. Guide to the Quality and Safety of Tissues and Cells for Human Application. EDQM; 2019.

2. EuroGTP. (2007 207) - Good tissue practices; 2007. Available from: http://eurogtps.com. Accessed May 2, 2023.

3. [VISTART] [676969]; Vigiliance and Inspection for the Safety of Transfusion AR and T. Principles for competent authorities for the evaluation and approval of clinical follow up protocols for blood, tissues and cells prepared with newly developed and validated processing methods; 2018:1–32.

4. EuroGTP II: a tool to assess risk, safety and efficacy of substances of human origin

5. EuroGTPII (709567)- Good Practices for demonstrating safety and quality through recipient follow-up. Euro GTP II Guide - good practices for evaluating safety, quality and efficacy of tissue and cellular therapies and products; 2020.

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