Pharmaceutical company BioPharma Services has received a $20m contract to conduct in vivo studies of generic drug products in human beings.
The five-year contract has been awarded by the US Food and Drug Administration (FDA) division Centre for Drug Evaluation and Research (CDER).
The in vivo studies are scheduled to begin later this year and expected to be completed by 2021.
BioPharma Services chief executive officer Renzo DiCarlo said: "We are very proud to work with the FDA in support of their generic drug programmes.
"This award is a great example of BioPharma’s capabilities as a leading industry expert in bioequivalence and early stage clinical research."
Through the FDA studies conducted by BioPharma, CDER will be able to answer scientific questions in developing generic approval standards, as well as ensure post-market safety and efficacy of approved generic drug products.
The studies will also help enhance the generic review practice within CDER.
BioPharma Services chief operating officer Brent Matthews said: "I am certain that our outstanding regulatory history with the FDA and our team’s extensive expertise in the conduct of Bioequivalence trials played a major role in landing this important contract with the FDA."
Under the deal, the pharmaceutical company will provide the FDA with a full service offering from study design inception to clinical conduct, bioanalysis and final report.
Image: BioPharma bags FDA contract to conduct in vivo studies of generic drug products in human beings. Photo: courtesy of Elza Fiúza / ABr – Agência Brasil.
