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Ponce, Rafael Abad, Leslie Amaravadi, Lakshmi Gelzleichter, Thomas Gore, Elizabeth Green, James Gupta, Shalini Herzyk, Danuta Hurst, Christopher Ivens, Inge A Kawabata, Thomas Maier, Curtis Mounho, Barbara Rup, Bonita Shankar, Gopi Smith, Holly Thomas, Peter Wierda, DanĪn evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

The Society of Toxicologic Pathology charged a Nervous System Sampling Working Group with devising recommended practices to routinely screen the central and peripheral nervous systems in Good Laboratory Practice-type nonclinical general toxicity studies. STP Position Paper: Recommended Practices for Sampling and Processing the Nervous System (Brain, Spinal Cord, Nerve, and Eye) during Nonclinical General Toxicity Studies Histologically, these accumulations often lack dist. Accumulation of endogenous and exogenous materials in lysosomes represents a common finding in nonclinical toxicity studies.

Lysosomes have a central role in cellular catabolism, trafficking, and processing of foreign particles.

Accordingly, many regulatory agencies have produced explicit guidelines for desig.Ĭharacterizing Adversity of Lysosomal Accumulation in Nonclinical Toxicity Studies: Results from the 5th ESTP International Expert Workshop Neuropathology analysis as an endpoint during nonclinical efficacy and toxicity studies is a challenging prospect that requires trained personnel and particular equipment to achieve optimal results. Compilation of International Regulatory Guidance Documents for Neuropathology Assessment during Nonclinical Toxicity Studies

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