Pancreatic Islets Quality and Potency Cannot be Verified as Required for Drugs: Reflection on the FDA Review of a Biological License Application for Human Islets.

Witkowski, Piotr; Anteby, Roi; Olaitan, Oyedolamu K; Forbes, Racheal C; Niederhaus, Silke; Ricordi, Camilo; Fair, Jeffrey H; Harland, Robert C

Witkowski, Piotr; Anteby, Roi; Olaitan, Oyedolamu K; Forbes, Racheal C; Niederhaus, Silke; Ricordi, Camilo; Fair, Jeffrey H; Harland, Robert C.

Witkowski P; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, IL.
Anteby R; Harvard T.H. Chan School of Public Health, Boston, MA.
Olaitan OK; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Forbes RC; Department of Surgery, Rush University Medical Center, Chicago, IL.
Niederhaus S; Division of Kidney and Pancreas Transplantation, Department of Surgery, Vanderbilt University Medical Center, Nashville, TN.
Ricordi C; Department of Surgery, University of Maryland School of Medicine, Baltimore, MD.
Fair JH; Diabetes Research Institute and Cell Transplant Center, University of Miami, Miami, FL.
Harland RC; Department of Surgery, University of Texas Medical branch, Galveston, TX.

Transplantation ; 105(12): e409-e410, 2021 12 01.

Article en En | MEDLINE | ID: mdl-34231527

Asunto(s)

Trasplante de Islotes Pancreáticos; Islotes Pancreáticos; Humanos; Insulina

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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Trasplante de Islotes Pancreáticos / Islotes Pancreáticos Límite: Humans Idioma: En Año: 2021 Tipo del documento: Article

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