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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 ivMicrotracerTM 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 rapid development and manufacture of iv dosage forms and their efficient integration into clinical studies.
ivMicrotracerTM studies can achieve savings of at least $1.5M in cost and 8-12 months in time, compared to traditional approaches.
In an ivMicrotracerTM 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 (iv dosed 14C compound) or conventional mass spectrometry techniques.
Pharmaceutical Profiles has established effective regulatory, manufacturing and clinical processes for the ivMicrotracerTM 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.
For more about Pharmaceutical Profiles ivMicrotracerTM studies and details of a recent paper that discusses applications in metabolism and pharmacokinetics using biomedical accelerator mass spectrometry, Expert Opinion on Drug Metabolism & Toxicology, August 2008, visit: www.pharmprofiles.com <http://www.pharmprofiles.com/>
About Pharmaceutical Profiles:
Pharmaceutical Profiles provides drug development support to most of the top pharmaceutical and biotechnology companies around the world.
A specialist in clinical drug development, the company has innovative technology and is pioneering a novel approach to rapid formulation development, manufacturing and early clinical testing.
Pharmaceutical Profiles has around 75 highly qualified staff. Facilities include a phase I GCP clinical unit, a GMP facility for the manufacture of Investigational Medicinal Products (IMPs), and formulation R&D facilities all integrated under one roof, just south of Nottingham in the UK.
The company’s world leading expertise in oral drug delivery has assisted the development of over 100 small molecules, peptides and protein therapeutics, including over 40 marketed drugs. In addition, the Pharmaceutical Profiles team has supported the development of the majority of inhaled drug delivery devices and formulations on the market today.