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Research ArticleTechnology/Application

Challenges Associated with Biological Safety Assessments for Drug-Device Combination Products

Cheryl L. M. Stults, Diane Harper and Doris Zane
PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 100-124; DOI: https://doi.org/10.5731/pdajpst.2022.012822
Cheryl L. M. Stults
1C & M Technical Consulting, LLC, San Mateo, CA;
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Diane Harper
2New York, NY; and
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Doris Zane
3Gilead Sciences, Foster City, CA
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  • For correspondence: doris.zane@gilead.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 1
January/February 2024
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Challenges Associated with Biological Safety Assessments for Drug-Device Combination Products
Cheryl L. M. Stults, Diane Harper, Doris Zane
PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 100-124; DOI: 10.5731/pdajpst.2022.012822
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  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug-–Device Combination Products
  • A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation
  • An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET)
  • Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
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Keywords

  • Biological reactivity
  • Biocompatibility
  • Analytical evaluation threshold (AET)
  • Toxicological assessment
  • Drug–device combination products
  • Extractables
  • Leachables

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Challenges Associated with Biological Safety Assessments for Drug-Device Combination Products
Cheryl L. M. Stults, Diane Harper, Doris Zane
PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 100-124; DOI: 10.5731/pdajpst.2022.012822

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