April C. Braddy - Center for Drug Evaluation and Research, Food and Drug Administration

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论文共 14 篇作者统计合作学者相似作者

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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

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

Journal of Pharmacy & Pharmaceutical Sciences (2024)

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The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications

Jan-Shiang Taur,Chunsheng Zhao, Mahesh Darna,Yang Chang, Yang Lu,Jinzhe Mao,Wendy Cai,Ke Ren,April C. Braddy

The AAPS Journal（2023）

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Reconciling Sprinkle Administration Information in Approved NDA Labeling with Sprinkle Bioequivalence Study Recommendations in FDA Product-Specific Guidances for Generic Drug Development

Suhryoung C. Chun,Patrick E. Nwakama,Devvrat T. Patel,Ke Ren,April C. Braddy

American Journal of Pharmacotherapy and Pharmaceutical Sciences (2022)

引用4浏览0引用

A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme

Andrew Tam,Alfredo Garcia-Arieta,Ivana Abalos,Eduardo Agostinho Freitas Fernandes,Gustavo Mendes Lima Santos,Zulema Rodriguez Martinez,Milly Divinsky,Rami Kariv,Henrike Potthast,April C. Braddy,Clare Rodrigues,Erwin Guzman Aurela, Liliana Carolina Arevalo Gonzalez,Diego Gutierrez Triana,Ben Jones, Choongyul Ahn, Hyuna Kim, So Hee Kim,Ryosuke Kuribayashi,Aya Myoenzono,Kohei Shimojo,Joy van Oudtshoorn, Cornelia Bigler, Ricarda Meincke,Matthias S. Roost,Chantal Walther,Li-feng Hsu,Christopher Crane,Tony Jarman

Journal of Pharmacy & Pharmaceutical Sciences（2022）

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Regulatory Standards for Approval of Topical Dermatological Drug Products

April C. Braddy,Dale P. Conner

Dermal Drug Deliverypp.331-360, (2020)

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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

Alfredo Garcia-Arleta,Craig Simon,Gustavo Mendes Lima Santos, Ivan Omar Calderon Lojero,Zulema Rodriguez Martinez,Clare Rodrigues,Sang Aeh Park, Ji Myoung Kim,Ryosuke Kuribayashi,Yusuke Okada,Arno Nolting, Chantal Pfaffli,Wen-Yi Hung,Christopher Crane,April C. Braddy,Joy van Oudtshoorn,Diego Gutierrez Triana,Mitch Clarke

Journal of Pharmacy & Pharmaceutical Sciences（2019）

引用8浏览0WOS引用

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

Joy van Oudtshoorn,Alfredo Garcia-Arieta,Gustavo Mendes Lima Santos,Christopher Crane,Clare Rodrigues,Craig Simon, Ji Myoung Kim,Sang Aeh Park,Yusuke Okada,Ryosuke Kuribayashi, Chantal Pfaffli,Arno Nolting, Ivan Omar Calderon Lojero,Zulema Rodriguez Martinez,Wen-Yi Hung,April C. Braddy, Nancy Arciniegas Leal,Diego Gutierrez Triana,Mitch Clarke, Peter Bachmann

Journal of Pharmacy & Pharmaceutical Sciences（2018）

引用17浏览0WOS引用

Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

April C. Braddy,Barbara M. Davit,Ethan M. Stier,Dale P. Conner

The AAPS Journal（2015）

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