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Journal of Pharmaceutical Sciences|February 7, 2018
Structure-Function Relationships for Recombinant Erythropoietins: A Case Study From a Proposed Manufacturing Change With Implications for Erythropoietin Biosimilar Study DesignsGustavo Grampp, Patricia L McElroy, Gary Camblin, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and InsulinsStella Stergiopoulos, Carrie A Brown, Gustavo Grampp, et al.
Drug Safety|September 18, 2016
A Survey of Adverse Event Reporting Practices Among US Healthcare ProfessionalsStella Stergiopoulos, Carrie A Brown, Thomas Felix, et al.
Expert Opinion on Drug Safety|January 6, 2015
Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilarsGustavo Grampp, Machaon Bonafede, Thomas Felix, et al.
Food and Drug Law Journal|February 1, 2014
Global regulatory standards for the approval of biosimilarsBarbara Mounho, Audrey Phillips, Kay Holcombe, et al.
Biotechnology Progress|November 28, 2023
Managing integrated continuous bioprocesses in real time: Deviations in product qualityGustavo Grampp, Allen Bosley, Maen Qadan, et al.
The AAPS Journal|April 5, 2015
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI ConferenceLawrence X Yu, Jeffrey Baker, Susan C Berlam, et al.
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