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- Published online July 31, 2020.
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- previous version (February 14, 2020 - 07:26).
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© PDA, Inc. 2020
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- 1Pharmaceutical Management Consultant, 565 Doan's Ridge Road, Welland ON L3B 5N7, Canada;
- 2Sanofi Pasteur, 1755 Steeles Avenue W, North York, ON M2R 3T4, Canada;
- 3Apotex Inc., 150 Signet Drive, Toronto ON M9L 1T9, Canada; and
- 4Eurofins Alphora Research Inc., 2450 Bristol Circle, Oakville, ON L6H 6P6, Canada.
- ↵*Corresponding Author: 565 Doan's Ridge Rd., Welland ON L3B 5N7, Canada; Telephone: 647-339-9637; E-mail: ajpazha{at}gmail.com
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- Article
- Abstract
- Introduction
- Scope Determination and Product/Process Review
- CQA Identification
- Material Attribute/Process Parameter Identification
- Material Attributes/Process Parameters Classification and Risk Factor Assignment
- Computing Risk Ratio and Constructing Risk Assessment Charts
- Potential Applications
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
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