Bioavailability (BA) and bioequivalence (BE) studies are required of new as well as generic drug products. BA/BE are parameters with practical and public health value for drug manufacturers, for regulatory agencies, and ultimately for patients. From a drug product performance perspective, BA studies also benchmark the performance of the formulation(s) used in the clinical trials. The performance of further reformulation of this product and subsequently its generic equivalent is expected to be linked to the benchmark performance of the clinical trial dosage form.
The objective of this one‐day workshop is to provide a broad perspective on the theory and practice of BA/BE, with a special emphasis on the utility of the Biopharmaceutic Classification System (BCS) as an important decision making tool for assessing drug product quality. As examples, generic drug products in Hong Kong and in Japan will be profiled according to the BCS. In addition to introducing quality‐by‐design (QbD) as a proactive strategy for incorporating critical quality attributes into drug formulation design, the workshop will conclude with an open forum on the way forward for BA/BE as the language of drug product quality in Hong Kong.
Theme: Health Technology Assessment: Impact on Health Care and Assessment of the Value of Medicines
Organizers: ISPOR Hong Kong Chapter and The Chinese University of Hong Kong
Co-organizers: ISPOR Asia Consortium, Shanghai Chapter and Beijing Chapters
Date: 25 June 2015 (Thursday)
Venue: G02, Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39 , CUHK
Time: 08:45a.m. – 5:00p.m.
Customizing drug delivery to treat patients burdened with a myriad of diseases in a therapeutically and cost effective manner while meeting the vigorous regulatory standards of quality is a formidable challenge in personalized medicine. This is underscored by the important decision making role of the patient in determining the therapeutic outcome, a phenomenon commonly referred to as adherence. The objective of this one-day workshop is to highlight multidisciplinary research intended to benefit the elderly. Professor Ping I. Lee, an eminent scholar in mass transport at the University of Toronto, will keynote the scientific principles that underline the technologies of modified drug release, including those intended for nasal, pulmonary, and direct intravitreal administration. Furthermore, patients may also benefit from research in measuring blood-brain barrier permeability and from advances in digitally-based technologies for monitoring progress in drug therapy real time. In the final analysis, formulations designed to compensate for the deterioration in postural balance, manual dexterity, swallowing, and cognitive acuity commonly seen in the elderly is a timely development. Let’s not forget China alone could have some 400 million people over 60 years of age by 2050. Therefore, the market demand for such formulations could be substantial.
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