Gustavo Mendes Lima Santos - Agencia Nacional de Vigilencia Sanitaria

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论文共 36 篇作者统计合作学者相似作者

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Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Sivacharan Kollipara,Frederico S. Martins,Maitri Sanghavi,Gustavo Mendes Lima Santos,Anuj Saini,Tausif Ahmed

JOURNAL OF PHARMACEUTICAL SCIENCES（2024）

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Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Sivacharan Kollipara,Frederico Severino Martins,Maitri Sanghavi,Gustavo Mendes Lima Santos,Anuj Saini,Tausif Ahmed

Journal of pharmaceutical sciences（2024）

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Incorporação E Uso De Medicamentos No Sistema Único De Saúde: Mudanças E Riscos Com Os Novos Atos Normativos Do Ministério Da Saúde

Rosângela Caetano,Luciane Cruz Lopes,Gustavo Mendes Lima Santos,Claudia Garcia Serpa Osorio-de-Castro

Cadernos de Saúde Públicano. 2 (2023)

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[Authorization for off-label use may not be beneficial for the Brazilian Unified National Health System]

Rosângela Caetano,Luciane Cruz Lopes,Gustavo Mendes Lima Santos,Claudia Garcia Serpa Osorio-de-Castro

Cadernos de saude publica（2023）

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Incorporation and Use of Medicines in the Brazilian Unified National Health System: Changes and Risks of New Ministry of Health Legislation

Rosangela Caetano,Luciane Cruz Lopes,Gustavo Mendes Lima Santos,Claudia Garcia Serpa Osorio-de-Castro

CADERNOS DE SAUDE PUBLICAno. 2 (2023)

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (part 1A-Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of L..

Surinder Kaur,Stephen C. Alley,Matt Szapacs,Amanda Wilson,Eugene Ciccimaro,Dian Su,Neil Henderson,Linzhi Chen,Fabio Garofolo,Shawna Hengel,Wenying Jian,John F. Kellie,Anita Lee,John Mehl,Joe Palandra, Haibo Qiu,Natasha Savoie,Diaa Shakleya,Ludovicus Staelens,Hiroshi Sugimoto,Giane Sumner,Jan Welink,Robert Wheller,Y-J Xue,Jianing Zeng,Jinhui Zhang, Huiyu Zhou,Jian Wang,Scott Summerfield,Olga Kavetska,Lieve Dillen,Ragu Ramanathan,Mike Baratta,Arindam Dasgupta,Anna Edmison,Luca Ferrari, Sally Fischer,Daniela Fraier,Sam Haidar, Kathrin Heermeier,Christopher James,Allena Ji,Lina Luo,Gustavo Mendes Lima Santos,Noah Post,Anton Rosenbaum,Sune Sporring,Sekhar Surapaneni,Stephen Vinter,Katty Wan,Eric Woolf,Seongeun (Julia) Cho,Elham Kossary,Sandra Prior,Mohsen Rajabi Abhari,Catherine Soo,Yow-Ming Wang,Abbas Bandukwala,Elana Cherry,Isabelle Cludts,Soma Ghosh,Shirley Hopper,Akiko Ishii-Watabe,Susan Kirshner,Kevin Maher,Kimberly Maxfield,Joao Pedras-Vasconcelos,Yoshiro Saito,Dean Smith,Therese Solstad,Daniela Verthelyi,Meenu Wadhwa,Leslie Wagner, Gunter Waxenecker,Haoheng Yan,Lucia Zhang

BIOANALYSIS（2022）

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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

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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2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (part 1-Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innov..

BIOANALYSIS（2021）

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Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

Hasumati Rahalkar,Alan Sheppard,Gustavo Mendes Lima Santos, Chitralekha Dasgupta,Sonia Mayra Perez-Tapia,Carlos A. Lopez-Morales,Sam Salek

Frontiers in Medicine（2021）

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ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Claudia Miranda,Alexis Aceituno,Mirna Fernandez,Gustavo Mendes,Yanina Rodriguez,Veronica Llauro,Miguel Angel Cabrera-Perez

Pharmaceuticsno. 3 (2021): 363-363

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