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

Cheryl L. M. Stults; Diane Harper; Doris Zane

doi:10.5731/pdajpst.2022.012822

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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vol. 78 no. 1 100-124

DOI

https://doi.org/10.5731/pdajpst.2022.012822

PubMed

37848201

Published By

Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

History

Published online February 20, 2024.

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previous version (October 17, 2023 - 05:56).
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Cheryl L. M. Stults¹,
Diane Harper² and
Doris Zane³,*

¹C & M Technical Consulting, LLC, San Mateo, CA;
²New York, NY; and
³Gilead Sciences, Foster City, CA

↵*Corresponding Author: 333 Lakeside Drive, Foster City, CA 94404; Telephone: (650) 425-2981; E-mail: doris.zane{at}gilead.com

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PDA Journal of Pharmaceutical Science and Technology

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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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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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Keywords

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

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