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A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme.
Van Oudtshoorn JE, García-Arieta A, Santos GML, Crane C, Rodrigues C, Simon C, Kim JM, Park SA, Okada Y, Kuribayashi R, Pfäffli C, Nolting A, Lojero IOC, Martínez ZR, Hung WY, Braddy AC, Leal NA, Triana DG, Clarke M, Bachmann P. Van Oudtshoorn JE, et al. Among authors: kim jm. J Pharm Pharm Sci. 2018;21(1):27-37. doi: 10.18433/J3X93K. J Pharm Pharm Sci. 2018. PMID: 29382433 Free article. Review.
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme.
Garcia Arieta A, Simon C, Lima Santos GM, Calderón Lojero IO, Rodríguez Martínez Z, Rodrigues C, Park SA, Kim JM, Kuribayashi R, Okada Y, Nolting A, Pfäffli C, Hung WY, Crane C, Braddy AC, Van Oudtshoorn J, Gutierrez Triana D, Clarke M. Garcia Arieta A, et al. Among authors: kim jm. J Pharm Pharm Sci. 2019;22(1):28-36. doi: 10.18433/jpps30215. J Pharm Pharm Sci. 2019. PMID: 30599818 Free article.
5,859 results