A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10-Reference-Cited by-同舟云学术

A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10

Published:2021-10 Issue: Volume:125 Page:105017
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Bauer Daniel^ORCID,Buckley Lorrene A.,Delafoy Laure,Ellinger-Ziegelbauer Heidrun,Fellows Mick D.,Gerets Helga H.J.,Howe Jonathan,Kaijser Gerry,Nicolette John,Pettersen Betty A.,Schimpf Brian

Funder

EFPIA

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference16 articles.

1. Standardized UV–vis spectra as the foundation for a threshold-based, integrated photosafety evaluation;Bauer;Regul. Toxicol. Pharmacol.,2014

2. The DGAT1 inhibitor pradigastat does not induce photosensitivity in healthy human subjects: a randomized controlled trial using three defined sunlight exposure conditions;Bauer;Photochem. Photobiol. Sci.,2016

3. Workshop Report: the 3T3 neutral red uptake phototoxicity test: practical experience and implications for phototoxicity testing – the report of an ECVAM–EFPIA workshop;Ceridono;Regul. Toxicol. Pharmacol.,2012

4. Note for Guidance on Photosafety Testing,2002

5. FDA Guidance for Industry–Photosafety Testing,2003

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1. Photosafety Assessment of Pharmaceuticals;Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays;2024

2. Phototoxicity─Medicinal Chemistry Strategies for Risk Mitigation in Drug Discovery;Journal of Medicinal Chemistry;2023-07-14

3. Development of a GCN-based model to predict <i>in vitro</i> phototoxicity from the chemical structure and HOMO-LUMO gap;The Journal of Toxicological Sciences;2023

4. Absence of phototoxicity/photoirritation potential of bergamottin determined In Vitro using OECD TG 432;Regulatory Toxicology and Pharmacology;2022-12

5. A proposed NAM-based tiered phototoxicity testing and human risk assessment framework for agrochemicals;Regulatory Toxicology and Pharmacology;2022-11