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Aflatoxins and Ochratoxin A in dried fruits from Morocco: Monitoring, regulatory aspects, and exposure assessment
Regul Toxicol Pharmacol. 2023 Sep 29:105503. doi: 10.1016/j.yrtph.2023.105503. Online ahead of print.ABSTRACTThe present study aims to investigate the presence of Aflatoxins (AF) in 180 samples dried fruits and Ochratoxin A (OTA) in 210 samples dried fruits and grape juices collected in Morocco. Mycotoxins were analyzed by high performance liquid chromatography (HPLC) coupled to fluorescence detection and immunoaffinity columns (IAC) cleanup. Contamination levels were compared with the maximum regulatory limits (MRL) recently adopted in the country, and mycotoxin exposure of adult consumers was assessed. Results showed tha...
Source: Regulatory Toxicology and Pharmacology : RTP - October 1, 2023 Category: Toxicology Authors: Nysrine Mannani Mounir El Boujamaai Aicha Sifou Mohamed Bennani Chakib El Adlouni El Hassane Abdennebi Abdellah Zinedine Source Type: research

Preclinical safety, toxicokinetics and metabolism of BIIB131, a novel prothrombolytic agent for acute stroke
Regul Toxicol Pharmacol. 2023 Sep 29:105498. doi: 10.1016/j.yrtph.2023.105498. Online ahead of print.ABSTRACTBIIB131, a small molecule, is currently in Phase 2 for the treatment of acute ischemic stroke. Safety and metabolism of BIIB131 were evaluated following intravenous administration to rats and monkeys. Exposure increased dose-proportionally in rats up to 60 mg/kg and more than dose-proportionally in monkeys at greater than 10 mg/kg accompanied by prolonged half-life and safety findings. The BIIB131 was poorly metabolized in microsomes with no inhibition of CYPs. BIIB131-glucuronide, formed by UGT1A1, accounted for 21...
Source: Regulatory Toxicology and Pharmacology : RTP - October 1, 2023 Category: Toxicology Authors: Vick Kostrubsky Ying Liu Cathy Muste Chungang Gu Melissa Kirkland Naoko Nishimura Keiko Hasegawa Keiji Hasumi Long Yuan Source Type: research

Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African medicines agency
CONCLUSIONS: As of June 2023, 35 of 55 countries have either signed and/or ratified the AMA Treaty, whilst 20 have neither signed nor ratified it. An effective AMA will need strong National Medicines Regulatory Authorities as well as regional programmes and it is imperative for more well-resourced countries to ratify the treaty to ensure access to essential medical products and technologies for the African people.PMID:37778434 | DOI:10.1016/j.yrtph.2023.105497 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - October 1, 2023 Category: Toxicology Authors: Nancy Ngum Margareth Ndomondo-Sigonda Stuart Walker Sam Salek Source Type: research

Harmonisation of read-across methodology for drug substance extractables and leachables (E & amp;Ls)
In conclusion, an E&L read-across methodology has been developed to provide a consistent, health protective framework for deriving HBELs when toxicology data is limited.PMID:37748702 | DOI:10.1016/j.yrtph.2023.105494 (Source: Regulatory Toxicology and Pharmacology : RTP)
Source: Regulatory Toxicology and Pharmacology : RTP - September 25, 2023 Category: Toxicology Authors: Melisa Masuda-Herrera Hannah T Rosen Anders Burild Thomas Broschard Troy Griffin Tyler Bell Jessica Graham Jedd Hillegass Penny Leavitt Brian Huta Trish Parris Uma Bruen Maureen Cruz Joel Bercu Source Type: research