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Pharmaceutical Profiles Completes First-of-a-Kind Integrated Clinical Study to Address all Aspects of Drug Bioavailability

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The exploratory study used the company’s proprietary EnterionTM, ivMicrotracerTM, and imaging technology and know-how to: assess oral bioavailability, regional gastrointestinal (GI) absorption; GI transit and degradation; absolute bioavailability and metabolite characteristics of a new drug. The complex study gained Medicines and Healthcare products Regulatory Agency (MHRA) approval in just 12 days - without comment or amendment.

“This study is at the very forefront of new thinking in drug development and shows what can be achieved with smarter design and integrated technologies. Clinical programmes can be progressed much more quickly and cost effectively through the early stages of drug development using these principles,” said Dr Andrew Rankin, Chief Scientific Officer at Pharmaceutical Profiles.

Results from this work, undertaken for San Diego-based Ardea Biosciences in support of their new oral anti-HIV drug, will prove invaluable for the efficient development of effective formulations for Phase II trials and beyond. The data will also inform the development of deconvolution techniques to establish in vitro/in vivo correlations (IV/IVC) as well as enable the pharmacokinetic/pharmacodynamic (PK/PD) modeling which underpins effective design and implementation of further clinical studies.

Dr Colin Rowlings, Senior Vice President, Pharmaceutical Sciences at Ardea Biosciences, said: “This novel study integrated several design aspects in an efficient manner that are traditionally addressed in separate studies. The insight obtained has been very useful in identifying the optimal dosage form for RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI), which is entering Phase 2b in HIV patients.”