Principle And Guidelines For Be Studies For Approval Of ANDA. International Journal of Research in Pharmacology & Pharmacotherapeutics, [S. l.], v. 12, n. 4, p. 276–283, 2023. DOI: 10.61096/ijrpp.v12.iss4.2023.276-283. Disponível em: https://ijrpp.com/ijrpp/article/view/503. Acesso em: 5 mar. 2026.