Chapter 4 - The needs from the regulatory authorities' perspective—current status and worldwide initiatives

Autor: Klein, Agnes V., Turner, Mark A., Sato, Junko

Publikováno v: In Essentials of Translational Pediatric Drug Development 2024:61-80

sj-docx-1-dst-10.1177_19322968231159360 – Supplemental material for Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches

Autor: Lorbetskie, Barry, Bigelow, Stewart, Walrond, Lisa, Klein, Agnes V., Loo, Shih-Miin, Green, Nancy, Rosu-Myles, Michael, Zhang, Xu, Lu, Huixin, Girard, Michel, Sauvé, Simon

Supplemental material, sj-docx-1-dst-10.1177_19322968231159360 for Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharma

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::77cec3aae04d0c1ff6e71c74e342c601

Contributors

Autor: Adeyeye, Moji, Ainsworth, Sammy, Al-Obaidi, Issraa, Allegaert, Karel, Amigoni, Angela, Annaert, Pieter, Athanassiou, Dimitris, Attar, Sabah, Barrett, Jeffrey S., Barrick, Daisy, Bassi, Adit, Batchelor, Hannah, Bax, Ralph, Bernays, Sarah, Bhatnagar, Melanie E., Bierer, Barbara E., Borens, Amanda, Borrell-Pages, Maria, Bruyne, Pauline De, Burckart, Gilbert J., Carmichael, Samantha, Cavaller-Bellaubi, Maria, Chatterjee, Sagnik, Cheng, Katharine, Conway, Magda, Corriol-Rohou, Solange, Croubels, Siska, De Boevre, Marthe, De Cock, Pieter A., Deforce, Dieter, Degraeuwe, Eva, De Schaepdrijver, Luc, De Sutter, Pieter-Jan, Devreese, Mathias, De Wildt, Saskia N., Dews, Sally Anne, Dhaenens, Maarten, Dossche, Lien, Driessens, Mariette, Duffy, Ciara, Evett, Sophie, Garcia-Bournissen, Facundo, Gasthuys, Elke, Getz, Kenneth, Goessens, Tess, Green, Dionna J., Harada, Tsutomu, Hedley, Victoria, Hermans, Eline, Heslop, Emma, Huitema, Alwin, Impens, Francis, Irvin, Anna, Ito, Shinya, Jafta, Lungile, Jennings, Kim, Kearns, Gregory L., Kienesberger, Anita, Klein, Agnes V., Kruger, Mariana, Langeraert, Jonas, Leary, Rebecca, Lepola, Pirkko, Matsui, Kenji, McCune, Susan, Metsvaht, Tuuli, Michelet, Robin, Nafria Escalera, Begoña, Nakamura, Hidefumi, Nelson, Robert, Oualha, Mehdi, Pearson, Andy, Pero-Gascon, Roger, Prasad, Bhagwat, Preston, Jennifer, Reaman, Gregory, Rizzari, Carmelo, Saito, Jumpei, Samardzic, Janko, Sato, Junko, Schrier, Lenneke, Scobie, Nicole, Sen, Anando, Smeets, Nori, Smits, Anne, Snyder, Donna L., Stitt, Gideon, Stones, Simon R., Straub, Volker, Tack, Bieke, Toelen, Jaan, Turner, Mark A., Turner, Katie, van den Anker, John, Ventrella, Domenico, Verhelst, Sigrid, Vermeulen, Eric, Vermeulen, An, Walle, Johan Vande, Wan, Mandy, Weinman, Ariane, Yao, Lynne, Zuppa, Athena F., Zwaan, C. Michel

Publikováno v: In Essentials of Translational Pediatric Drug Development 2024:xi-xv

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