Search Results - "Abalos, Ivana"

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 by Fernandes, Eduardo Agostinho Freitas, van Oudtshoorn, Joy, Tam, Andrew, González, Liliana Carolina Arévalo, Aurela, Erwin Guzmán, Potthast, Henrike, Mettke, Katalina, Kuribayashi, Ryosuke, Shimojo, Kohei, Kasuga, Miho, Morales, Lázaro, Rodríguez, Zulema, Jones, Ben, Ahn, Choongyul, Yun, Eunju, Kim, So Hee, Rodrigues, Clare, Tiong, Toh, Crane, Christopher, Walther, Chantal, Roost, Matthias S, Chen, Tzu-Ling, Hsu, Li-Feng, Braddy, April C, García-Arieta, Alfredo, Abalos, Ivana, Divinsky, Milly, Alsuwyeh, Abdulaziz, Alzenaidy, Bader, Alharf, Adel

“…Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently…”
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A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme by Tam, Andrew, Garcia-Arieta, Alfredo, Abalos, Ivana, Agostinho Freitas Fernandes, Eduardo, Mendes Lima Santos, Gustavo, Rodriguez Martinez, Zulema, Divinsky, Milly, Kariv, Rami, Potthast, Henrike, Braddy, April C, Rodrigues, Clare, Guzman Aurela, Erwin, Carolina Arevalo Gonzalez, Liliana, Gutierres Triana, Diego, Jones, Ben, Ahn, Choongyul, Kim, Hyuna, Kim, So Hee, Kuribayashi, Ryosuke, Myoenzono, Aya, Shimojo, Kohei, Van Oudtshoorn, Joy, Bigler, Cornelia, Meincke, Ricarda, Roost, Matthias S, Walther, Chantal, Hsu, Li-Feng, Crane, Christopher, Jarman, Tony

“…The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is…”
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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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Transepithelial transport of biperiden hydrochloride in Caco-2 cell monolayers by Abalos, Ivana S, Rodríguez, Yanina I, Lozano, Verónica, Cereseto, Marina, Mussini, Maria V, Spinetto, Marta E, Chiale, Carlos, Pesce, Guido

“…Abstract The aim of this research has been to determine the biperiden hydrochloride permeability in Caco-2 model, in order to classify it based on the…”
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