Radiolabeled In Vivo ADME Services

Drugs for which mass balance study results can be obtained from acceptable literature sources or FDA-approved product labeling.

Drugs such as monoclonal antibodies, endogenous substances, and analogs (e.g., peptides, hormones, oligonucleotide therapeutics) with known metabolism and elimination pathways based on basic pharmacology and nonclinical ADME information.

Drugs with the majority of the dose (i.e., greater than or equal to 90 percent) recovered in the urine as the unchanged parent drug with minimum metabolism.

Drugs with no or negligible systemic exposures.

First, to track how compounds of interest are distributed in the body, even for small tissues; second, to assess melanin associated binding in pigmented rodents (like pigmented Long-Evans rats), and calculate human dosimetry dosage from the tissue distribution data.

In addition to the general tissue distribution studies, QWBA technology also can be used in placental transfer study, tumor distribution study, etc.

For preclinical studies, the purity is recommended to be >95%, and single impurity<1%.

For clinical studies, the purity is recommended to be >98%, and single impurity<1%.

SA is the abbreviation of special activity. The common unit is mCi/mmol. The maximum achievable specific activity for single ¹⁴C-labeled organic compound is 62.4 mCi/ mmol. In fact, the specific activity of the synthesized in ¹⁴C-labeled compound is a little lower. It is usually between 40 and 50 mCi/mmol.