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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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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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  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • 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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