{"id":5716,"date":"2022-08-01T08:04:28","date_gmt":"2022-08-01T13:04:28","guid":{"rendered":"https:\/\/labtesting.\/?p=5716"},"modified":"2023-07-10T10:27:23","modified_gmt":"2023-07-10T15:27:23","slug":"in-vivo-adme-testing-in-drug-development-a-short-guide","status":"publish","type":"post","link":"https:\/\/labtesting.\/2022\/08\/01\/in-vivo-adme-testing-in-drug-development-a-short-guide\/","title":{"rendered":"In Vivo ADME Testing in Drug Development: A Short Guide"},"content":{"rendered":"\n

In vitro and in vivo ADME studies provide valuable data about a test article as it moves through preclinical development<\/a>. In this short guide, we provide an overview of in vivo ADME testing, including why it\u2019s important and how it works.<\/p>\n\n\n\n

For a successful Investigational New Drug (IND) submission, drug developers need to put together a complete data package that includes in vivo studies. An IND package requires an assessment of<\/a> the pharmacokinetics and biological disposition of the test article in animals and information on the ADME properties of the test article, if known. This typically starts with in vitro testing<\/a> before moving on to in vivo ADME testing.<\/p>\n\n\n\n

The data generated from in vivo ADME studies provide a more complete picture of safety and risk \u2013 and make the test article more compelling for clinical approval. As a result, in vivo ADME studies are required to file a New Drug Application (NDA).<\/p>\n\n\n\n

What Is in vivo<\/em> ADME Testing?<\/h3>\n\n\n\n

In vivo ADME studies are generally conducted with radioactive labels on the target test article to provide quantitative information on the mass of distribution, rate of metabolism, and pathway of excretion for the test article and its metabolites.<\/p>\n\n\n\n

While in vitro ADME studies<\/a> are performed outside of a living organism in a controlled environment, in vivo studies are done within a living system. Researchers also conduct ex vivo studies, in which samples of tissues, cells, blood or plasma are collected from an in vivo system but experimented on or investigated outside of the natural in vivo environment. The information gleaned from in vitro ADME assays help researchers and developers move forward with ex vivo and in vivo studies.<\/p>\n\n\n\n

In vivo ADME falls under the Drug Metabolism and Pharmacokinetics (DMPK<\/a>) umbrella following an understanding of the test article\u2019s toxicology. While some in vivo ADME testing can occur early on in discovery, most in vivo tests typically happen later in the stage of optimizing the structure and properties of the test article. They are sometimes one of the last studies conducted prior to first-time radiolabeled clinical studies.<\/p>\n\n\n\n

Later-stage in vivo ADME studies administer radiolabel test articles to living systems. Radiolabeled test articles incorporate a radioisotope that allow researchers to track the passage of a molecule through the system. After dosing, you can examine ADME properties:<\/p>\n\n\n\n

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