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Review ArticleReview

Gamma Sterilization of Pharmaceuticals—A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations

Fatima Hasanain, Katharina Guenther, Wayne M. Mullett and Emily Craven
PDA Journal of Pharmaceutical Science and Technology March 2014, 68 (2) 113-137; DOI: https://doi.org/10.5731/pdajpst.2014.00955
Fatima Hasanain
Nordion, Ottawa, Ontario, Canada
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Katharina Guenther
Nordion, Ottawa, Ontario, Canada
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Wayne M. Mullett
Nordion, Ottawa, Ontario, Canada
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Emily Craven
Nordion, Ottawa, Ontario, Canada
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Article Information

vol. 68 no. 2 113-137
DOI 
https://doi.org/10.5731/pdajpst.2014.00955
PubMed 
24668600

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online March 25, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

  1. Fatima Hasanain,
  2. Katharina Guenther,
  3. Wayne M. Mullett and
  4. Emily Craven
  1. Nordion, Ottawa, Ontario, Canada
  1. Corresponding Author: Nordion, 447 March Road, Ottawa, Ontario, Canada K2K 1X8. Tel: +1 613 592 3400 ext 2044, E-mail: Emily.Craven{at}nordion.com
  1. All authors contributed equally to this paper and are all considered as first authors.

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PDA Journal of Pharmaceutical Science and Technology: 68 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 2
March/April 2014
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Gamma Sterilization of Pharmaceuticals—A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations
Fatima Hasanain, Katharina Guenther, Wayne M. Mullett, Emily Craven
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 113-137; DOI: 10.5731/pdajpst.2014.00955

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Gamma Sterilization of Pharmaceuticals—A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations
Fatima Hasanain, Katharina Guenther, Wayne M. Mullett, Emily Craven
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 113-137; DOI: 10.5731/pdajpst.2014.00955
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  • Article
    • Abstract
    • Introduction
    • Pharmaceuticals and Excipients
    • Polymer Drug Delivery Systems
    • Regulatory Validation Guidelines and Decision Tree for Pharmaceutical Terminal Irradiation
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
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  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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Keywords

  • review
  • Sterilization
  • Gamma
  • API
  • Polymers
  • excipients
  • Irradiation
  • Validation

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