Publications by authors named "Clare Rodrigues"

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A survey of regulatory recommendations for waivers of bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.
Alfredo García-Arieta, Andrew Tam, Florencia Tiseyra, Eduardo Agostinho Freitas Fernandes, Kelen Carine Costa Soares, Clare Rodrigues

J Pharm Pharm Sci· November 2025

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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 Arévalo González, Erwin Guzmán Aurela, Clare Rodrigues

J Pharm Pharm Sci· April 2024

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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, Clare Rodrigues

J Pharm Pharm Sci· October 2022

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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.
Matthias Shona Roost, Henrike Potthast, Chantal Walther, Alfredo García-Arieta, Ivana Abalos, Clare Rodrigues

J Pharm Pharm Sci· January 2022

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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.
Alfredo Garcia Arieta, Craig Simon, Andrew Tam, Gustavo Mendes Lima Santos, Eduardo Agostinho Freitas Fernandes, Clare Rodrigues

J Pharm Pharm Sci· October 2021

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Project Orbis: Global Collaborative Review Program.
R Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Michael Shum, Laila Sofia Mouawad, Clare Rodrigues

Clin Cancer Res· December 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 Arieta, Craig Simon, Gustavo Mendes Lima Santos, Iván Omar Calderón Lojero, Zulema Rodríguez Martínez, Clare Rodrigues

J Pharm Pharm Sci· July 2020

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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.
Joy Elizabeth Van Oudtshoorn, Alfredo García-Arieta, Gustavo Mendes Lima Santos, Christopher Crane, Clare Rodrigues

J Pharm Pharm Sci· September 2019

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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.
Christopher Crane, Gustavo Mendes Lima Santos, Eduardo Agostinho Freitas Fernandes, Craig Simon, Andrew Tam, Clare Rodrigues

J Pharm Pharm Sci· January 2019

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