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Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.
Hotaki LT, Shrestha A, Bennett MP, Valdes IL, Lee SH, Wang Y, Spillman D, MacAulay T, Hunt M, Gervais J, Mafi M, Panetta V, Looi YH, Shum M, Atiek E, Meincke R, Rohr UP, Ainbinder D, Boehm-Cagan A, Luxenburg O, Cerqueira MR, Mouawad LS, Thees MFRES, Prasad K, de Claro RA. Hotaki LT, et al. Among authors: meincke r. Ther Innov Regul Sci. 2023 Jul;57(4):875-885. doi: 10.1007/s43441-023-00522-4. Epub 2023 Apr 18. Ther Innov Regul Sci. 2023. PMID: 37072651 Review.
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme.
Tam A, Garcia-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodriguez Martinez Z, Divinsky M, Kariv R, Potthast H, Braddy AC, Rodrigues C, Guzman Aurela E, Carolina Arevalo Gonzalez L, Gutierres Triana D, Jones B, Ahn C, Kim H, Kim SH, Kuribayashi R, Myoenzono A, Shimojo K, Van Oudtshoorn J, Bigler C, Meincke R, Roost MS, Walther C, Hsu LF, Crane C, Jarman T. Tam A, et al. Among authors: meincke r. J Pharm Pharm Sci. 2022;25:323-339. doi: 10.18433/jpps33081. J Pharm Pharm Sci. 2022. PMID: 36251699 Free article.
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