Live biotherapeutic products: the importance of a defined regulatory framework by Magali Cordaillat-Simmons, Alice Rouanet, Bruno Pot

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Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA by Jeanne-Céleste Paquet, Sandrine P. Claus, Magali Cordaillat-Simmons, Wilfrid Mazier, Georges Rawadi, Laure Rinaldi, Frédéric Elustondo, Alice Rouanet

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Live Biotherapeutic Products, A Road Map for Safety Assessment by Alice Rouanet, Selin Bolca, Audrey Bru, Ingmar Claes, Helene Cvejic, Helene Cvejic, Haymen Girgis, Ashton Harper, Sidonie N. Lavergne, Sophie Mathys, Marco Pane, Bruno Pot, Bruno Pot, Colette Shortt, Wynand Alkema, Constance Bezulowsky, Stephanie Blanquet-Diot, Christophe Chassard, Sandrine P. Claus, Benjamin Hadida, Charlotte Hemmingsen, Cyrille Jeune, Björn Lindman, Garikai Midzi, Luca Mogna, Charlotta Movitz, Nail Nasir, Manfred Oberreither, Jos F. M. L. Seegers, Luc Sterkman, Audrey Valo, Frédérique Vieville, Magali Cordaillat-Simmons

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