PT  - JOURNAL ARTICLE
AU  - Ayres, John D
TI  - Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations
AID  - 10.5731/pdajpst.2018.008615
DP  - 2018 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2018.008615
4099  - http://journal.pda.org/content/early/2018/08/27/pdajpst.2018.008615.short
4100  - http://journal.pda.org/content/early/2018/08/27/pdajpst.2018.008615.full
AB  - Visible particulate matter in injectables presents one important question for consideration: ″What are the potential implications to the patient?″; The risks of visible particulate matter to patient safety have been comprehensively reviewed elsewhere. However, the methods utilized to assess and characterize the risk have been explained with various degrees of specificity and supporting rationale. To date, the assessment process lacks the necessary consensus to permit a more standardized and consistent approach to evaluate the potential patient risks. The purpose of this commentary is to provide one paradigm that might be utilized to evaluate the three most relevant factors impacting the risk of injections containing particulate matter: the source of the particle; particle-specific attributes; and characteristics of the intended patient population. Each of these factors are considered with a focus on the more important aspects that might be relevant to imposing untoward risk. The discussion also includes the importance of differentiating the concepts of risk assessment from risk acceptance when establishing criticality levels for product attributes.