Please provide some background about the unit and its previous work experience with BEQ studies.
ZenTech has been conducting bioequivalence studies since 1987 and has conducted in excess of 250 Phase 1 clinical trials, clinical efficacy and safety studies.
Do you have sufficient bed space to perform a 36 or 60 volunteer study?
We have two individual facilities for conducting studies. One site holds a maximum of 36 subjects and the other site holds a maximum of 24 subjects. The two sites can be combined to hold up to 60 subjects.
Do you have the facilities to contain subjects overnight to ensure fasting and alcohol free prior to study dosing?
Yes, subjects are inducted into the clinical site 12 hours prior to dosing to ensure fasting and alcohol free conditions are adhered to.
Has your site ever been inspected by any Regulatory Authority or another pharmaceutical company?
We have been inspected by representatives of the Austrian Health Authority and are regularly inspected by pharmaceutical companies from Australia, New Zealand, Europe and the USA as part of their in-house auditing procedures.
To date, our practices and procedures are compliant with the ICH and GCP Guidance for conducting bioequivalence and clinical studies.
Do you have your own pharmacist(s)?
Our company director, Dr C T Hung, is a registered pharmacist.
Is there a lab and is it accredited (if yes, what accreditation)?
We have our own laboratory, which is ISO 9001:2000 accredited. Our laboratory has also been inspected for compliance to GLP and GCP by a number of pharmaceutical companies.
What equipment does the laboratory have?
Our laboratory is equipped with instruments such as balances, centrifuges, vacuum centrifuge, UV and fluorescence spectrometer, temperature and humidity controlled cabinets and -70˚C freezers. We currently have a range of LCMS and LCMSMS equipment including Schimadzu LCMS 2010A, applied Biosystems API 5000, 4000 and 3200. We also have many HPLC systems with UV, fluorescence and electrochemical detectors. However, LCMS and LCMSMS are usually employed for analysis of drugs in samples from bioequivalence studies.
In addition, we also have dissolution apparatus to conduct dissolution testing.
Which ethics committee(s) would you be submitting the protocol to for approval?
The Zenith Biomedical Ethics Committee is an independent ethics committee accredited by the Health Research Council of New Zealand to review clinical investigation involving healthy volunteers.. The committee generally meet on the first Wednesday of every month (except for January). In addition, we can organise submission of studies to the Regional Ethics Committee for patient studies.
How do you recruit your volunteers? What range of volunteers do you have available?
ZenTech has a substantial database of potential volunteers. In addition, we recruit through Student Job Search and regularly advertise locally. Our volunteers are healthy male and female generally aged 18 to 55.
When are the next ethics committee submission and meeting dates?
Generally the first Wednesday of every month with the exception of January. Cut-off for submission is 1 week prior to each meeting.
Will the studies be conducted in accordance with GCP?
All studies are conducted according to the ICH GCP Guidance for Bioavailability and Bioequivalence studies.