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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: walther c. 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.
Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis.
Rheault MN, Alpers CE, Barratt J, Bieler S, Canetta P, Chae DW, Coppock G, Diva U, Gesualdo L, Heerspink HJL, Inrig JK, Kirsztajn GM, Kohan D, Komers R, Kooienga LA, Lieberman K, Mercer A, Noronha IL, Perkovic V, Radhakrishnan J, Rote W, Rovin B, Tesar V, Trimarchi H, Tumlin J, Wong MG, Trachtman H; DUPRO Steering Committee and DUPLEX Investigators. Rheault MN, et al. N Engl J Med. 2023 Dec 28;389(26):2436-2445. doi: 10.1056/NEJMoa2308550. Epub 2023 Nov 3. N Engl J Med. 2023. PMID: 37921461 Clinical Trial.
Novel Tumor Organoid-Based Mouse Model to Study Image Guided Radiation Therapy of Rectal Cancer After Noninvasive and Precise Endoscopic Implantation.
Felchle H, Brunner V, Groll T, Walther CN, Nefzger SM, Zaurito AE, Silva MG, Gissibl J, Topping GJ, Lansink Rotgerink L, Saur D, Steiger K, Combs SE, Tschurtschenthaler M, Fischer JC. Felchle H, et al. Among authors: walther cn. Int J Radiat Oncol Biol Phys. 2024 Mar 15;118(4):1094-1104. doi: 10.1016/j.ijrobp.2023.10.008. Epub 2023 Oct 22. Int J Radiat Oncol Biol Phys. 2024. PMID: 37875245 Free article.
441 results