Biodistribution service aimed at diagnostic and therapeutic radio pharmaceuticals for the nuclear medicine market
Pharmaceutical Profiles - an early phase drug development services company that utilises sophisticated medical imaging techniques to evaluate pharmaceutical product performance in man - recently launched its biodistribution services with an exhibit at the 49th annual Society of Nuclear Medicine Meeting in Los Angeles, USA.
The ccompany also plans to exhibit later in August/September at the European Association of Nuclear Medicine Congress in Vienna, Austria, to complete the launch in Europe. Biodistribution investigations determine the safety and effectiveness of radiopharmaceuticals in phase I/IIa clinical trials.
Radiopharmaceuticals are used in diagnostic imaging and therapeutic applications in nuclear medicine.
There are an increasing number of new radiopharmaceutical products in development, all of which must pass rigorous testing to determine their efficacy and safety.
Biodistribution investigations determine the safety and effectiveness of radiopharmaceuticals in phase I/IIa clinical trials.
Pharmaceutical Profiles's biodistribution division is well placed to service this growing market, leveraging its established experience in the area of gamma scintigraphy.
The recent investment in a state-of-the-art dual-headed gamma camera, as well as the hiring of key personnel, has enabled Pharmaceutical Profiles to offer comprehensive biodistribution study services to pharmaceutical companies with radiopharmaceuticals in phase I/IIa development.
Pharmaceutical Profiles is the first contract research company to offer a tailor-made scientific, clinical and regulatory biodistribution service and it believes there are significant advantages in assessing new diagnostic agents in such a commercial environment. Recently revised FDA guidelines have sought to clarify and expand the scope of early phase clinical trials required for such products.
These regulations place increased emphasis on the pharmacological and toxicological response of both the radionuclide and the ligand (carrier) components, in addition to the evaluation of the radiation absorbed dose and biodistribution.
"Despite revisions to the FDA regulations in this area, there is much confusion and uncertainty with in the design of early phase clinical trials", explained Dennis Heller, vice president, biodistribution business development for Pharmaceutical Profiles, "Our experience over the past several years in assisting clients with the optimisation of clinical trial objectives, to address the concerns set forth by regulatory agencies such as the FDA, sets us apart from other centres" explained Dr Heller.
"For many companies this experience is often the key to initiating a successful clinical programme." In recent years, the trend has been for the design of very comprehensive Phase I/IIa studies with multiple objectives to address safety, pharmacokinetics and biodistribution.
Historical providers such as academic research centres and nuclear medicine departments within hospitals will be increasingly less able to manage these types of studies due to their complexity and demand for dedicated resources.
