Visible particles in parenteral drug products: A review of current safety assessment practice

Author:

Liu Frank,Hutchinson Richard

Funder

Janssen Pharmaceutica

Publisher

Elsevier BV

Reference91 articles.

1. Particle safety assessment in additive manufacturing from exposure risk to advanced tox testing;Alijagic;Front. Toxicol.,2022

2. APIC (Active Pharmaceutical Ingredients Committee), 2015. Guidance on handling of insoluble matter and foreign particles in APIs. https://www.gmp-compliance.org/files/guidemgr/20150626ForeignParticleGuideline_final.pdf.

3. Immune cell response to orthopedic and craniofacial biomaterials depends on biomaterial composition;Avery;Acta Biomater.,2023

4. Barba, T.A., 2000. Chapter 1. Introduction and overview. In: Control of Particulate Matter Contamination in Healthcare Manufacturing. first ed. pp. 1–579.

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