Biopharmaceutics can be defined as the study of how the physicochemical properties of a drug, the dosage form and the route of administration affect the rate and extent of drug absorption. Effective biopharmaceutical characterisation of new chemical entities is a key factor throughout drug development. Biopharmaceutical properties help to guide formulation design and choice of delivery system, however profiling dosage form performance under conditions which are relevant to in vivo conditions remains a challenge to pharmaceutical scientists. The Biopharmaceutics Focus Group was established within APS in 1999 to provide a forum for discussion of such challenges and to promote awareness of this discipline within Pharmaceutical Sciences.
The Focus Group steering committee has representation from industrial scientists in a number of large pharma companies including Pfizer, GSK, AstraZeneca, academics from King’s College London, UCL School of Pharmacy, University of Bath, Huddersfield, De Montfort and Birmingham Universities and specialist technology companies including Quotient, SEDA, PSe and Simcyp. A number of focus group members are participants in the Innovative Medicines Initiative funded ‘OrBiTo’ project which is seeking to develop the next-generation of innovative tools for oral biopharmaceutics.
The Focus Group will promote scientific education and training in the field of biopharmaceutics to meet the needs of scientists working in both industrial and academic sectors. The Focus Group will provide an active community of practice for those interested in the science of oral drug absorption and through this network seek to develop opportunities for cross-sector pre-competitive collaboration. The Focus Group will contribute to the scientific programme for the annual APS PharmSci meeting and organise additional symposia to promote awareness of innovative approaches for oral drug delivery and biopharmaceutics.
Professor Nikoletta Fotaki is a Professor of Biopharmaceutics at the University of Bath. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. With a strong background in translational biopharmaceutics, her research relates to the development of in vitro and in silico tools for the prediction of drug absorption in normal and in special populations, Physiologically Based Pharmacokinetic/ Physiologically Based Biopharmaceutics modeling, dissolution methods, IVIVCs and biowaivers. Over the last 20 years she has worked in a number of scientific projects in industry and academia on biopharmaceutical aspects during all stages of development. She is also a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.
Dr. Chara Litou is a Senior PBPK consultant at Certara, supporting various projects in all clinical phases of drug development. Prior to joining Certara, Chara worked as a DMPK Project Leader and Modelling and Simulation Scientist at Idorsia Pharmaceuticals Ltd., where she supported various projects in the preclinical and clinical phases and led the company’s Clinically Relevant Specifications/ Biopharmaceutics Working Group.
She is a pharmacist and holds a PhD in Biopharmaceutics and Pharmacokinetics, awarded by the Goethe University, Frankfurt, under the supervision of Professor Jennifer Dressman. She is an advocate of biopharmaceutics and strongly supports the combination of PBPK modelling with appropriate in vitro biorelevant/biopredictive setups to assess and predict the in vivo performance of drug products throughout clinical development, not only in the field of absorption but also of metabolism, transporters, and overall Drug-Drug Interactions.
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