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Bioequivalence risk assessment of oral formulations containing racemic ibuprofen through a chiral physiologically based pharmacokinetic model of ibuprofen enantiomers.
Reig-López J, Cuquerella-Gilabert M, Bandín-Vilar E, Merino-Sanjuán M, Mangas-Sanjuán V, García-Arieta A. Reig-López J, et al. Among authors: garcia arieta a. Eur J Pharm Biopharm. 2024 Jun;199:114293. doi: 10.1016/j.ejpb.2024.114293. Epub 2024 Apr 17. Eur J Pharm Biopharm. 2024. PMID: 38641229 Free article.
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.
Fernandes EAF, van Oudtshoorn J, Tam A, González LCA, Aurela EG, Potthast H, Mettke K, Kuribayashi R, Shimojo K, Kasuga M, Morales L, Rodríguez Z, Jones B, Ahn C, Yun E, Kim SH, Rodrigues C, Tiong T, Crane C, Walther C, Roost MS, Chen TL, Hsu LF, Braddy AC, García-Arieta A, Abalos I, Divinsky M, Alsuwyeh A, Alzenaidy B, Alharf A. Fernandes EAF, et al. Among authors: garcia arieta a. J Pharm Pharm Sci. 2024 Mar 21;27:12398. doi: 10.3389/jpps.2024.12398. eCollection 2024. J Pharm Pharm Sci. 2024. PMID: 38577255 Free PMC article. Review.
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.
Manolis E, García-Arieta A, Lindahl A, Kotzagiorgis E, Limberg J, Holte Ø, Paixao P, Versantvoort C, Tshinanu FM, Blake K, Van Den Heuvel M. Manolis E, et al. Among authors: garcia arieta a. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):556-559. doi: 10.1002/psp4.12906. Epub 2023 Jan 11. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36628987 Free PMC article. No abstract available.
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: garcia arieta a. J Pharm Pharm Sci. 2022;25:323-339. doi: 10.18433/jpps33081. J Pharm Pharm Sci. 2022. PMID: 36251699 Free article.
92 results