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Research ArticleCommentary

Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology January 2012, 66 (1) 63-77; DOI: https://doi.org/10.5731/pdajpst.2012.00742
Dennis Jenke
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References

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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 1
January/February 2012
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Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 63-77; DOI: 10.5731/pdajpst.2012.00742
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  • Article
    • Abstract
    • Introduction
    • Terminology
    • Risk Management and Safety Assessment
    • Testing Intervals in a Migration (Leachables) Study
    • Proper Use of Suppliers' Extractables Data
    • Conclusion
    • Acknowledgment
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Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 63-77; DOI: 10.5731/pdajpst.2012.00742

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