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Alliance with CIAB for bioequivalence studies in Chile

07/03/2012 - Biopharmaceutics
AGQ Labs and CIAB (Centro de Investigaciones Avanzadas en Biomedicina of Universidad de Concepción) have consolidated an alliance for collaboration in clinical trials of bioequivalence. In this regard CIAB is to be responsible of the development of Clinical Trial Research, Pharmacokinetics and Statistical Analysis. On the other hand, in AGQ we have a modern facility for participating as a bioanalytical laboratory, specialized in sample analysis of Bioequivalence trials.

The study director and principal investigators are a technical staff comprised of clinical pharmacists, pharmacologists and PhDs.

Phases of bioequivalence study:

Clinical Phase

The bioequivalence trials are considered as clinical trials, specifically as phase I study, the general requirements and recommendations of GCP apply to all bioequivalence trials. Clinical trials must be carried out under conditions which ensure adequate safety of the subjects.

The organization or institution performing bioequivalence studies is responsible for determining the specifications of the sampling method, volume and number of healthy Volunteers.

CIAB and Hospital Guillermo Grant Benavente from VIII Región in Chile, is the first regional center for bioequivalence trials.  This center has the accreditation of ISP since September, 2011.

Bioanalytical data (laboratory phase)

Two processes are important before the sample analysis:  validation of the analytical method and the study to support the stability of the samples. And then analysis of biological samples from clinical trials.

The analysis is performed in AGQ with established quality assurance systems. In this sense we used the general principles of GLP. We, also, have the ISO accreditation to participate like a bioanalytical laboratory in bioequivalence trials.

AGQ Labs is a Technological Center with advanced technologies in analytical chromatographic equipment (LC-MS. High resolution, highly sensitive, connected to mass-mass spectophotometry).  Moreover our technical staff of researchers, chemists and pharmacologists, allows our company to be leaders in bioanalytical studies.

Pharmacokinetic and statistical calculations

In this phase, the principal investigator is a full professor in the University, pharmacist and pharmacologist. The data generated in the bioanalytical phase, is evaluated to demonstrate bioequivalence between innovator and generic drugs.