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.