Service Related Frequently Asked Questions
QPlease provide some background about the unit and its previous work experience with bioequivalence studies.
AZentech has been conducting bioequivalence studies since 1987 and has conducted in excess of 500 Phase 1 clinical trials, clinical efficacy and safety studies.
QDo you have sufficient bed space to perform a 36 or 60 volunteer study?
AWe 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.
QDo you have the facilities to contain subjects overnight to ensure fasting and alcohol free prior to study dosing?
AYes, subjects are inducted into the clinical site 12 hours prior to dosing to ensure fasting and alcohol free conditions are adhered to.
QHas your site ever been inspected by any Regulatory Authority or another pharmaceutical company?
AWe have been inspected by the Austrian Health Authority on behave of EU and the US FDA. We are regularly audited by pharmaceutical companies from Australia, USA, Europe, India and New Zealand 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.
QDo you have your own pharmacist(s)?
AZentech has a registered in-house pharmacist and independent registered pharmacist expertise as required
QWhat medical expertise do you have available?
AZentech currently has in-house New Zealand Medical Council-registered medical practitioners and draws on further medical expertise, such as in dermatology, anaesthesiology, and oncology, as required for particular studies. Our medical director maintains’ Physician Investigator” status with the Association of Clinical Research Professionals.
QIs there an analytical lab and is it accredited (if yes, what accreditation)?
AWe have our own analytical laboratory, which is ISO 9001:2008 certified. Our laboratory has also been inspected for compliance to GLP and GCP by EU and US FDA and a number of pharmaceutical companies.
QWhat equipment does the laboratory have?
AOur laboratory is equipped with instruments such as balances, centrifuges, vacuum centrifuge, UV and fluorescence spectrometer, robotic liquid handling workstation, 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 and long term stability testing.
We are also equipped to perform ELISA and other analytical techniques as required for particular studies.
QWhich ethics committee(s) would you be submitting the protocol to for approval?
AThe four New Zealand Health and Disability Ethics Committees are responsible for the ethical oversight of our studies. (http://ethics.health.govt.nz/)
QHow do you recruit your volunteers? What range of volunteers do you have available?
AZentech has a substantial database of healthy volunteers. In addition, we regularly advertise locally. Our participants are male and female, generally aged between 18 and 55 years.
QWhen are the next ethics committee submission and meeting dates?
AGenerally, every Tuesday of each week. Cut-off for submission is 1 week prior to each meeting, at noon.
QWill the studies be conducted in accordance with GCP?
AAll studies are conducted according to the ICH GCP.