RT Journal Article
SR Electronic
T1 Challenges Associated with Biological Safety Assessments for Drug-Device Combination Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 100
OP 124
DO 10.5731/pdajpst.2022.012822
VO 78
IS 1
A1 Stults, Cheryl L. M.
A1 Harper, Diane
A1 Zane, Doris
YR 2024
UL http://journal.pda.org/content/78/1/100.abstract
AB Biological safety assessments for drug–device combination products involve evaluation of the drug container closure and the device constituent part. When the device constituent part is the drug delivery system as well as the drug container closure system, both device and drug-based packaging standards have been deemed applicable. Approaches used for the biological safety assessment of medical devices differ from those used for pharmaceutical packaging/delivery systems. One area of difference is the extent to which chemical characterization with toxicological assessment is used either in addition to, or in place of, biological in vivo or in vitro tests. Differences also exist in the way nonclinical studies are used to evaluate the safety of medical devices or drug delivery systems. The lack of alignment in standards and guidance has resulted in confusion over what combination of tests and methods of evaluation constitute a biological safety assessment that will meet regulatory expectations for a drug–device combination product. The intent of this article is to discuss the challenges created when the packaging or delivery system is also a device constituent part of a drug–device combination product. Suggestions are offered regarding approaches that may be useful for conducting suitable biological safety assessments for drug–device combination products.