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Investigation on the possibility of biowaivers for ibuprofen.
Alvarez C, Núñez I, Torrado JJ, Gordon J, Potthast H, García-Arieta A. Alvarez C, et al. Among authors: potthast h. J Pharm Sci. 2011 Jun;100(6):2343-9. doi: 10.1002/jps.22472. Epub 2011 Jan 14. J Pharm Sci. 2011. PMID: 21491448 Clinical Trial.
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
Gwaza L, Gordon J, Welink J, Potthast H, Hansson H, Stahl M, García-Arieta A. Gwaza L, et al. Among authors: potthast h. Eur J Clin Pharmacol. 2012 Dec;68(12):1611-8. doi: 10.1007/s00228-012-1396-1. Epub 2012 Sep 21. Eur J Clin Pharmacol. 2012. PMID: 23011014 Clinical Trial.
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: potthast h. 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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