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- Published online October 5, 2020.
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- previous version (April 15, 2020 - 10:05).
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© PDA, Inc. 2020
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- ↵*Corresponding Author: RD Chief Regulatory Office, GSK, 1250 South Collegeville Rd., Collegeville, PA, 19426. Telephone: +1 610-917-2666. E-mail: kavita.x.ramalingamiyer{at}gsk.com
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- Article
- Abstract
- 1. Introduction
- 2. Evaluation of the Impact of Postapproval Changes
- 3. Definition of Comparability
- 4. Elements of Analytical Comparability
- 5. Considerations for the Comparability Exercise
- 6. Concluding Remarks
- 7. Case Studies: Scientific Risk-Based Approach for Designing Analytical Comparability
- Conflict of Interest Declaration
- Acknowledgements
- Footnotes
- References
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