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FDA Taps Simcyp to Develop Dog Simulator for Veterinary Medicine


Simcyp, a division of Certara, said this week that it has entered into a Cooperative Research and Development Agreement with the US Food and Drug Administration to further develop the Simcyp Dog model for the evaluation of drug products intended for use in different canine breeds.

Over the next five years, Simcyp and researchers at the FDA's Center for Veterinary Medicine will develop physiologically based pharmacokinetic dog models that will help streamline the process of veterinary drug product development and evaluation.

Simcyp already provides an animal PBPK simulator, based on the Simcyp Population-based Simulator, for the beagle dog, rat, and knock-out mouse.

The partners will apply pharmacokinetic modeling to address complex questions associated with the design and interpretation of target animal safety studies and clinical field studies, Simcyp said.

Furthermore, they will enable the integration of model predictions with data from safety and effectiveness studies to support the development of informative product labels, Simcyp said.

The virtual dog models will provide a way to evaluate different dose requirements while taking into account genetic variations between breeds, Amin Rostami-Hodjegan, Simcyp’s vice president of scientific research and development, noted in a statement.

The Scan

For Better Odds

Bloomberg reports that a child has been born following polygenic risk score screening as an embryo.

Booster Decision Expected

The New York Times reports the US Food and Drug Administration is expected to authorize a booster dose of the Pfizer-BioNTech SARS-CoV-2 vaccine this week for individuals over 65 or at high risk.

Snipping HIV Out

The Philadelphia Inquirer reports Temple University researchers are to test a gene-editing approach for treating HIV.

PLOS Papers on Cancer Risk Scores, Typhoid Fever in Colombia, Streptococcus Protection

In PLOS this week: application of cancer polygenic risk scores across ancestries, genetic diversity of typhoid fever-causing Salmonella, and more.