Work Item
ASTM WK76862

New Guide for Identification of Nanoparticles Ability to Induce Infusion Reactions

1. Scope

The development of standards and guidance for nanotechnology & nanomaterials, and 2) the coordination of existing ASTM standardization related to nanotechnology needs. This coordination shall include the apportioning of specific requests for nanotechnology standards through ASTM's existing committee base, as well as the maintenance of appropriate global liaison relationships with activities (internal and external) related to this subject area. The Committee shall participate in the development of symposia, workshops, and other related activities to enhance the development of standards.

Keywords

nanomaterials

Rationale

4.1 Infusion reactions (IRs) are complex, immune-mediated side effects that mainly occur within minutes to hours of receiving a therapeutic dose of intravenously administered pharmaceutical products. 4.2 These products include both traditional pharmaceuticals, such biologics and small molecules, and new ones, such as nanomedicines. 4.3 Although IRs are not unique to nanomedicines, they represent a hurdle for the translation of nanotechnology-based drug products

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E56.03

Committee: E56

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 05-10-2021

Technical Contact: Marina Dobrovolskaia

Item: 001

Ballot: E56.03 (21-02)

Status: Withdrawn From Balloting

Item: 001

Ballot: E56 (21-05)

Status: Negative Votes Need Resolution