Drug Metabolism & Pharmacokinetics
Once a drug is taken, its effect is determined largely by how well it is absorbed, distributed, metabolized in and eliminated from the body. The Drug Metabolism & Pharmacokinetics Team looks at these drug behaviors (ADME properties) and helps the chemists, and pre-clinical and clinical scientists determine how to optimize the drug for best performance. They also look at how the drug should be formulated (e.g. into a tablet, capsule, or an oral or injectable solution), how often it should be administered, and what important information, like potential interactions with food or other drugs, may be necessary to reduce side effects or maintain therapeutic effectiveness.
The information gathered by the team can come from two sources:
- Preclinical experiments conducted to predict drug behavior in humans by measuring its behavior in biological assays, in vitro and in vivo models, and
- Clinical data collected from volunteers and actual patients participating in proof-of-concept, phase I, II, and III studies.
Each source informs the other, so that the ADME measurements in humans are fed back to the laboratory assays to improve their predictive power, while the improved assays help refine the design of subsequent clinical trials. The information collected in clinical pharmacokinetics studies is used to write labeling instructions provided directly to patients, doctors and regulatory scientists.
It’s a perfect example of how NIBR brings the laboratory and the clinic together to improve efficiency and performance in the discovery of new drugs, and to help patients and medical professionals use our drug products safely and effectively.