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Bioavailability/Bioequivalence (BA/BE) Trials

Development of generic drugs is of major importance to helping promote affordability of medicines, bringing treatments and health benefits to broader patient population. Bioavailability/bioequivalence (BA/BE) data is a common requirement for registration of generic drugs in most countries/places or procurement of generic drugs by major hospitals and healthcare institutions.

The HKU Phase 1 Clinical Trials Centre is a 24-bed clinical research facility well-equipped to conduct BA/BE trials – whether on small molecule drugs or biosimilars – as well as phase 1 and early phase trials. HKU-CTC’s professional clinical trial management team is capable of supporting generic drug manufacturers in planning, initiating and completing their BA/BE trials fulfilling the requirements for regulatory registration or procurement by hospitals and healthcare institutions.

Key Service Capabilities
Dedicated medical team with clinical experts in clinical pharmacology, oncology and other key therapeutic areas
Dedicated clinical operations team composed of professional study coordinators, registered nurses, pharmacists, dispensers and laboratory specialists
Rapid and detailed feasibility assessment coordinated by specialists in business and project intelligence
Protocol development or consultation on protocol development by a professional protocol development team comprising experts in medical/clinical sciences, ethics/regulatory requirements, clinical operations, study budgeting, data management, medical statistics and medical writing
Comprehensive project management capabilities supporting quick study start-up and streamlined study operations
Full support on ethics and regulatory submissions by ethics and regulatory specialists
Efficient budgeting and contracting process facilitated by budgeting and contract specialists (with master clinical trial agreements (Master CTAs) or CTA templates established with over 170 sponsors worldwide)
Strong data management and statistical support by professional data managers and medical statisticians
Full support by the CAP-accredited clinical laboratory in QMH
Pharmacokinetic analysis support by the HKU Pharmacokinetics Laboratory
Access to healthy volunteers and patients in a wide range of disease areas

Safety and Quality Management
Ongoing safety monitoring by staff-on-duty, supported by on-site safety monitoring system and surveillance camera system
On-site medical emergency support by qualified clinical staff, using on-site dedicated resuscitation room, equipment and materials
24-hour medical emergency support by QMH’s central resuscitation team and intensive care unit (ICU)
Robust quality assurance (QA) system established based on the principles of total quality management (TQM)
Intensive internal quality control (QC) for each study
Long-term archiving of study records in professional document storage facilities through HKU-CTC’s ArchiveEasy service

Key Study Capabilities
BA/BE trials on small molecule drugs
Biosimilars trials