Pharmaceutical Profiles Delivers Critical ivPK Data in Early Drug Development

The generation of human intravenous pharmacokinetic (ivPK) data early in the development of new oral medicines can help to address a range of critical issues including low and variable oral bioavailability. However, it is seldom collected until late in drug development - due to the high cost of developing an iv formulation and the extended toxicology studies that are required to support a clinical study.

Now, with the successful completion of its fifth clinical study in this area, Pharmaceutical Profiles’ (Ruddington, UK) has established a novel ivMicrotracer™ methodology that allows human ivPK data to be generated early in drug development.

The new protocol exploits the company’s know-how and capabilities in development and manufacture of iv dosage forms and their efficient integration into clinical studies.

ivMicrotracer™ studies can achieve savings of at least $1.5M in cost and 8-12 months in time, compared to traditional approaches.

In an ivMicrotracer™ study, once an oral therapeutic dose has achieved its maximum concentration (Cmax), an iv microdose of 14C labelled drug is administered. Both iv and orally administered compound are detected in plasma samples using accelerator mass spectrometry or conventional mass spectrometry techniques.

Pharmaceutical Profiles has established effective regulatory, manufacturing and clinical processes for the ivMicrotracer™ protocol. Clients who have adopted this approach so far range from large multinational pharmaceutical companies to small biotechnology companies, working from locations across North America, Europe, and Japan.