Located in Jakarta, Indonesia, our new 4-storeyoffice and laboratory has an integrated clinical and analytical site that designated to meet the the regulatory authority requirements and international standard for GCP, GLP, and BA/BE study.
a. Clinical Facilities
* Facility for BA/BE study:
- Clinical subjects' service room for 28 persons
- Subject recreation section
- Overnight stay rooms with separated men/women facilities
- Sampling collection rooms
- Clinical laboratory for volunteers screening
- Physical examination and consultations room
- Controlled sample storage rooms
- Drug storage
PT Equilab International has a volunteer database of almost 600 potential study participants.
* Clinical laboratory:
- Hematology analyzer (Cell Dyne Emerald-Abbott)
- Chemistry Analyzer (T C 84)
- Urine Test Reader (Uritex Reader)
b. Bioanalytical Facilities
Our bioanalytical site is facilitated by assay instruments:
- Alliance Waters 2695 HPLC coupled to Waters 2475 multi λ fluorescence detector and Waters 2996 photo-diode array detector
- Alliance Waters 2695 HPLC coupled to Waters 2487 dual λ absorbance detector and Waters 2475 multi λ fluorescence detector
- Alliance HT Waters 2795 HPLC coupled to Waters Micro-mass quatro micro triple quadrapole (MS/MS) detectors (API and ESCi interface)
- Waters ACQUITY® TQD with ACQUITY UPLC® System
- Shimadzu UV-1800 UV-VIS Spectrophotometers
c. Statistical Analysis Program
EquivTest version 2.0 (Statistical Solution Ltd., Saugus, MA, USA) is used to perform the statistical analyses of AUCt, AUCinf, and Cmax using analysis of variance (ANOVA) after transformation of the data to their natural logarithmic (ln) values
