Dep. of Clinical Pharmacology (Phase I Unit)
Dep. of Clinical
Pharmacology is a leading Phase I unit based at
Being on the Shanghai Medical College of Fudan University gives the Phase I unit access to all the facilities of this famous teaching hospital and we can call on specialist advice and opinion in many therapeutic areas.
The department now contains a total of 8 fully-monitored clinical beds in two wards and 16 dormitory beds run by 4 full-time nurses and 2 research physicians, trained in performing Phase I studies. The clinical beds all have HP ECG monitoring equipment.
We can invite other physicians to take part in the different studies in part time to cover a wide variety of specialties. The hospital clinical laboratory facilities are available for performing comprehensive biochemical and haematological safety tests and qualitative screening tests for an extensive range of drugs.
The analytical laboratory can also perform assays on test compounds, allowing the development and validation of assay methodology, using the Sponsor’s technology where appropriate or developing assays if none are available. Techniques available include LC-MS/MS and HPLC.
The range of studies include:
• first administration to man • bioavailability/bioequivalence
• single and multiple dose tolerance and safety
• dose-effect relationship • metabolism studies
• food effects and drug delivery • drug interactions
• Pharmacokinetics/pharmacodynamics • use of surrogate markers
The department has conducted studies in a wide variety of therapeutic areas including:
• cardiovascular and system
• nervous system
• anaesthetic agents
• musculo-skeletal system
• gastrointestinal system
• respiratory system
• endocrine system
Since 1985 the Phase I unit has evaluated more than 50 new chemical compounds. This extensive experience combined with optimal study design (an interactive process with the Sponsor) and excellent interpretative skills, has enabled the department on many occasions, to provide an indication of the clinical efficacy of a compound before conventional Phase II trials have commenced.
Although specializing in healthy volunteer studies, Zhong Shan hospital is a qualified organization for drug clinical trial by SFDA of China, performs Phase II to Phase IV studies also in cardiovascular diseases, renal impairment, respiratory diseases, diabetes, cancer, infection and inflammation, blood and neuoplastic disease, anaesthetic agents, etc. The specialist from the different fields of the hospital is responsible for the studies.
Over the years we have worked with most of the major pharmaceutical companies in the world, such as:
l Bristol-Myers Sqibb
l many Chinese pharmaceutical factories.