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Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
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 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: rodriguez martinez z.
J Pharm Pharm Sci. 2019;22(1):28-36. doi: 10.18433/jpps30215.
J Pharm Pharm Sci. 2019.
PMID: 30599818
Free article.
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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: rodriguez martinez z.
J Pharm Pharm Sci. 2021;24:113-126. doi: 10.18433/jpps31491.
J Pharm Pharm Sci. 2021.
PMID: 33734975
Free article.
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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: rodriguez martinez z.
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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