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Year Number of Results
2001 1
2002 1
2003 1
2004 1
2010 1
2013 1
2014 1
2015 1
2016 1
2018 1
2019 2
2020 3
2021 2
2022 1
2023 1

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Page 1
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: braddy ac. J Pharm Pharm Sci. 2022;25:323-339. doi: 10.18433/jpps33081. J Pharm Pharm Sci. 2022. PMID: 36251699 Free article.
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: braddy ac. J Pharm Pharm Sci. 2018;21(1):27-37. doi: 10.18433/J3X93K. J Pharm Pharm Sci. 2018. PMID: 29382433 Free article. Review.
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
Roost MS, Potthast H, Walther C, García-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodríguez Martínez Z, Tam A, Rodrigues C, Gutierrez Triana DA, Guzmán Aurela E, Rodríguez Rodríguez N, Aeh Park S, Kim J, Kariv R, Divinsky M, Jones B, Kuribayashi R, Myoenzono A, Kasuga M, Van Oudtshoorn J, Chi JF, Hung WY, Hsu LF, Crane C, Jarman T, Braddy A. Roost MS, et al. Among authors: braddy a. J Pharm Pharm Sci. 2021;24:548-562. doi: 10.18433/jpps32260. J Pharm Pharm Sci. 2021. PMID: 34706215 Free article. Review.
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme.
Garcia Arieta A, Simon C, Tam A, Mendes Lima Santos G, Freitas Fernandes EA, Rodríguez Martínez Z, Rodrigues C, Park SA, Kim J, Kim K, Kuribayashi R, Myoenzono A, Shimojo K, Walther C, Roost MS, Hung WY, Hsu LF, Crane C, Braddy AC, Van Oudtshoorn J, Gutierrez Triana DA, Guzmán Aurela E, Jones B, Potthast H, Abalos I. Garcia Arieta A, et al. Among authors: braddy ac. J Pharm Pharm Sci. 2021;24:113-126. doi: 10.18433/jpps31491. J Pharm Pharm Sci. 2021. PMID: 33734975 Free article.
18 results