Search Results - "Agostinho Freitas Fernandes, Eduardo"

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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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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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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Internal Standards (IS) monitoring in CROs: Anvisa perspective by Lima Santos, Gustavo Mendes, Freitas Fernandes, Eduardo Agostinho

“…The implementation of the Generic Medicines Policy had the objective of increasing access to medicines and ensuring their quality, safety and efficacy(1).The…”
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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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Experiences and initiatives on pharmacokinetic modeling and simulation data analysis: Perspectives from the Brazilian Health Regulatory Agency (ANVISA) by Borges, Luiza Novaes, Fernandes, Eduardo Agostinho Freitas, Oliveira, Érico Miroro de, Pereira, Victor Gomes, Diniz, Andréa

“…The landscape of drug product development and regulatory sciences is evolving, driven by the increasing application of systems thinking and modeling and…”
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Experiences and Initiatives on Pharmacokinetics Modeling and Simulation Data analyses: Perspectives from the Brazilian Health Regulatory Agency (ANVISA) by Borges, Luiza Novaes, Fernandes, Eduardo Agostinho Freitas, Oliveira, Érico Miroro de, Pereira, Victor Gomes, Diniz, Andréa

“…The landscape of drug product development and regulatory sciences is evolving, driven by the increasing application of systems thinking and modeling and…”
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