Proposed approach to scientific risk-based comparability study Design for biologics

Kavita Ramalingam Iyer; Isabelle Lequeux

doi:10.5731/pdajpst.2019.010439

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Proposed approach to scientific risk-based comparability study Design for biologics

Kavita Ramalingam Iyer and Isabelle Lequeux

PDA Journal of Pharmaceutical Science and Technology April 2020, pdajpst.2019.010439; DOI: https://doi.org/10.5731/pdajpst.2019.010439

Kavita Ramalingam Iyer

1 Merck & Co., Inc.;

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For correspondence: kavita_iyer@merck.com

Isabelle Lequeux

2 BioPhorum

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For correspondence: isabelle@biophorum.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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Proposed approach to scientific risk-based comparability study Design for biologics

Kavita Ramalingam Iyer, Isabelle Lequeux

PDA Journal of Pharmaceutical Science and Technology Apr 2020, pdajpst.2019.010439; DOI: 10.5731/pdajpst.2019.010439

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Proposed approach to scientific risk-based comparability study Design for biologics

Kavita Ramalingam Iyer, Isabelle Lequeux

PDA Journal of Pharmaceutical Science and Technology Apr 2020, pdajpst.2019.010439; DOI: 10.5731/pdajpst.2019.010439

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Keywords

ICH Guidelines
Post-approval changes
Risk-based evaluation of change
Biologics
comparability
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Parenteral Drug Association, Inc.