FDA Law Blog

OCTOBER 10, 2023

subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation). Imaging Compatibility and Radiotherapy Compatibility Demonstration of whether the presence of the device impacts the image quality (e.g.,

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

Drug Discovery World

MAY 10, 2023

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issues guidelines and develops testing strategies for evaluating carcinogenicity along with other risks such as genotoxicity, immunotoxicity, and reproductive toxicity. Toxicologic Pathology. 2011;39(4):716-744.

Bioassay 52

Bioassay Genotoxicity Drugs In-Vivo 52

The Pharma Data

MAY 13, 2021

Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Journal of Food Engineering. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109. Cardoso FS, Araujo-Lima CF, Aiub CA, Felzenszwalb I.

Insulin 52

Insulin Production Hormones Medicine 52