Search Results - "Van Oudtshoorn, Joy"

A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme by Garcia Arieta, Alfredo, Simon, Craig, Lima Santos, Gustavo Mendes, Calderón Lojero, Iván Omar, Rodríguez Martínez, Zulema, Rodrigues, Clare, Park, Sang Aeh, Kim, Ji Myoung, Kuribayashi, Ryosuke, Okada, Yusuke, Nolting, Arno, Pfäffli, Chantal, Hung, Wen-Yi, Crane, Christopher, Braddy, April C, Van Oudtshoorn, Joy, Gutierrez Triana, Diego, Clarke, Mitch

“…The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally…”
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A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme by Van Oudtshoorn, Joy Elizabeth, García-Arieta, Alfredo, Santos, Gustavo Mendes Lima, Crane, Christopher, Rodrigues, Clare, Simon, Craig, Kim, Ji Myoung, Park, Sang Aeh, Okada, Yusuke, Kuribayashi, Ryosuke, Pfäffli, Chantal, Nolting, Arno, Lojero, Iván Omar Calderón, Martínez, Zulema Rodríguez, Hung, Wen-Yi, Braddy, April C, Leal, Nancy Arciniegas, Triana, Diego Gutierrez, Clarke, Mitch, Bachmann, Peter

“…The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in…”
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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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The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities by Crane, Christopher, Santos, Gustavo Mendes Lima, Fernandes, Eduardo Agostinho Freitas, Simon, Craig, Tam, Andrew, Triana, Diego Gutierrez, Potthast, Henrike, Kuribayashi, Ryosuke, Okada, Yusuke, Myoenzono, Aya, Calderon, Ivan Omar, Rodriguez, Zulema, Jones, Ben, Park, Sang Aeh, Eum, So Young, Rodrigues, Clare, Van Oudsthoorn, Joy, Nolting, Arno, Walther, Chantal, Roost, Matthias S, Hung, Wen-Yi, Braddy, April C, Garcia-Arieta, Alfredo

“…In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage…”
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