Reactive oxygen species assay-based risk assessment of drug-induced phototoxicity: Classification criteria and application to drug candidates

Phototoxic Risk Assessments on Benzophenone Derivatives: Photobiochemical Assessments and Dermal Cassette-Dosing Pharmacokinetic Study

“…3 ): 20] (Onoue et al, 2008(Onoue et al, , 2014b. On the basis of these criteria, BZ, KT, MX, and OX were found to be photoreactive, and these BZPs would cause phototoxic reactions in the skin.…”

“…Perceptible adverse events would leave patients and consumers with negative impressions of products, and the pharmaceutical and cosmetic industries have struggled to predict and/or avoid phototoxic events. In the early 2000s, regulatory agencies, including the Food and Drug Administration, the European Medicines Agency, and the Organization for Economic Cooperation and Development (OECD), established guidance on photosafety testing of medicinal products (EMEA/CPMP, 2002, 2008FDA/CDER, 2002;OECD, 2004). In 2014, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) established the ICH S10 guideline (ICH, 2014), and this guidance describes photosafety assessment strategies on the basis of photochemical/photobiological properties and in vivo pharmacokinetic (PK) behaviors in UV-exposed tissues, such as skin and eyes.…”

“…In particular, UV-visible measurement (Henry et al, 2009), 3T3 neutral red uptake phototoxicity test (3T3 NRU PT) (Spielmann et al, 1994), and/ or reactive oxygen species (ROS) assay (Onoue and Tsuda, 2006;Onoue et al, 2008) are currently described as recommended methodologies for evaluating the photosafety of test substances, and these photosafety assessment tools are also useful in the early stages of product development. Although effective in vitro photosafety assessments have been developed on the basis of photochemical/photobiological mechanisms, the data obtained from these methodologies cannot fully reveal the occurrence of phototoxic events in a clinical context due to a lack of data on distribution and retention in UV-exposed tissues.…”

Establishment of an <i>in silico</i> phototoxicity prediction method by combining descriptors related to photo-absorption and photo-reaction

“…ROS assay can detect ROS generations both of results of photo-reactions and photo-decomposition of chemicals, but phototoxicity was related to the ROS generation in the result photo-reactions (Onoue et al, 2008(Onoue et al, , 2012. Therefore, the false positive of ROS assay to 3T3 NRU-PT might be related to not photo-reaction but photo-decomposition.…”

Kozmetik Ürünlerin Fototoksik Etkileri: Mekanizması ve Alternatif Test Metotları

“…Işık ile uyarılma sırasında ve fotoreaksiyon sonrasında ROB oluşumu ile bir kimyasal maddenin fototoksik potansiyeli in chemico olarak değerlendirilebilir (58). Singlet oksijen p-nitrozodimetilanilin ile tespit edilirken, peroksit üretimi "Nitro Blue Tetrazolyum Testi (NBT-Formazan ekstraksiyonu)" ile belirlenir (36). Bu yöntem kozmetik ürünler için %90 hassaslıkta ve %76,9 özgünlüktedir; diğer kimyasal maddeler için ise sırasıyla %100 hassaslıkta ve %75 özgünlükte olduğu belirlenmiştir.…”