Search Results - "Gutierrez Triana, Diego Alejandro"

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 by Garcia Arieta, Alfredo, Simon, Craig, Tam, Andrew, Mendes Lima Santos, Gustavo, Freitas Fernandes, Eduardo Agostinho, Rodríguez Martínez, Zulema, Rodrigues, Clare, Park, Sang Aeh, Kim, JaYoung, Kim, Kwansoo, Kuribayashi, Ryosuke, Myoenzono, Aya, Shimojo, Kohei, Walther, Chantal, Roost, Matthias S, Hung, Wen-Yi, Hsu, Li-Feng, Crane, Christopher, Braddy, April C, Van Oudtshoorn, Joy, Gutierrez Triana, Diego Alejandro, Guzmán Aurela, Erwin, Jones, Ben, Potthast, Henrike, Abalos, Ivana

“…The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System…”
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Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities by Roost, Matthias Shona, Potthast, Henrike, Walther, Chantal, García-Arieta, Alfredo, Abalos, Ivana, Agostinho Freitas Fernandes, Eduardo, Mendes Lima Santos, Gustavo, Rodríguez Martínez, Zulema, Tam, Andrew, Rodrigues, Clare, Gutierrez Triana, Diego Alejandro, Guzmán Aurela, Erwin, Rodríguez Rodríguez, Nayive, Aeh Park, Sang, Kim, Jayoung, Kariv, Rami, Divinsky, Milly, Jones, Ben, Kuribayashi, Ryosuke, Myoenzono, Aya, Kasuga, Miho, Van Oudtshoorn, Joy, Chi, Jo-Feng, Hung, Wen-Yi, Hsu, Li-Feng, Crane, Christopher, Jarman, Tony, Braddy, April

“…This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release…”
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