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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: lojero ioc. J Pharm Pharm Sci. 2018;21(1):27-37. doi: 10.18433/J3X93K. J Pharm Pharm Sci. 2018. PMID: 29382433 Free article. Review.