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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.
J Pharm Pharm Sci. 2022;25:323-339. doi: 10.18433/jpps33081.
J Pharm Pharm Sci. 2022.
PMID: 36251699
Free article.
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: agostinho freitas fernandes e.
J Pharm Pharm Sci. 2021;24:548-562. doi: 10.18433/jpps32260.
J Pharm Pharm Sci. 2021.
PMID: 34706215
Free article.
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