ADME/Tox INSIGHTS


Quality and study design considerations for carcinogenicity testing with the rasH2

75% of mouse carcinogenicity studies submitted to the FDA utilize the rasH2 mouse model (Tg.rasH2), a model accepted by the FDA as an alternative to the two-year in vivo bioassay for predicting human carcinogenic risk. In an evolving carcinogenicity testing landscape, with the utility of two-year rat bioassay under re-consideration and changes under consideration to the ICH guidelines for carcinogenic risk assessment, several key questions come to...

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Improving Your ADME/Tox Processes

Despite initiatives to improve the regulatory arena to speed up drug development and therefore reduce the cost of approval, it is still a long and expensive process to bring drugs to market. As a result, resources must be directed primarily to the drug candidates most likely to work. The key to improving that situation lies in refining early-stage drug screening through the use ADME/Tox. In the Nov...

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rasH2 Helps Improve Drug Testing

GEN Exclusives has published an article by Amar Thyagarajan, Ph.D., Senior Product Manager at Taconic Biosciences, titled New Guidelines Involve the Testing Done on Animal Models. In his article, Dr. Thyagarajan helps us understand the nature of proposed changes to carcinogenicity safety testing to significantly reduce the amount of time and money it takes to achieve drug approval. A two-year rodent bio-assay to ascertain carcinogenicity has been...

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When Is Less More In Carcinogenicity Testing?

The rasH2 mouse model is used for carcinogenicity testing of genotoxic and non-genotoxic compounds. Over the last decade, it has become the leading alternative to the traditional 2-year rodent lifetime bioassay. In a recent opinion article, Paranjpe et al. (Paranjpe et al., 2014, Toxicologic Pathology, XX: 1-10), evaluated study design of carcinogenicity studies using the rasH2 model, particularly with respect to the dose groups of the compound...

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Challenges and Prospects in Predicting the ADME and Toxicity Characteristics of Drugs in Humans

One of the key challenges of drug development is to better predict drug responses in humans. This white paper offers insights on how such challenges are being overcome by a portfolio of pre-validated in vivo and in vitro tools. These tools offer solutions along various stages of the drug development pipeline and help improve drug candidate selection, increase clinical success rates, and reduce costs. Applications include use...

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