Bioequivalence Test Unit
PROFILE
BIOEQUIVALENCE TESTING UNIT of the ITB School of Pharmacy is a laboratory under the ITB School of Pharmacy, whose activities are to conduct bioavailability and bioequivalence (BA/BE) testing of drug preparations, including dissolution tests. This activity is a contribution from the ITB School of Pharmacy in supporting the government’s program to improve the quality of drug preparations circulating in Indonesia.
As the forerunner of the BIOEQUIVALENCE TESTING UNIT of the ITB School of Pharmacy is the Biopharmaceutical Laboratory of the Department of Pharmacy – FMIPA – ITB which has started its activities in biopharmaceutical research since 1987, when the government launched the generic drug program with a logo. BIOEQUIVALENCE TESTING UNIT of the ITB School of Pharmacy serves and collaborates with the pharmaceutical industry in order to assess the quality of its products and/or fulfill the completeness of registration of finished drugs that it produces.
VISION & MISSION
Vision
To become a superior, trusted and independent bioavailability and bioequivalence (BA/BE) testing laboratory that can compete at national, regional and international levels.
Mission
To provide quality BA/BE testing services, prioritizing scientific and objective aspects, by implementing the latest principles of GCP & GLP standards.
SERVICE COVERAGE
BIOEQUIVALENCE TESTING UNIT ITB School of Pharmacy serves the following tests:
- Bioavailability and Bioequivalence Tests
- Dissolution Tests
- And others related to biopharmaceutical and pharmacokinetic aspects
FACILITIES
Sampling Room and its equipment
- Sampling room
- A set of equipment for blood sampling and processing
- Subject rest room
- Subject sleeping room
- Special chair for blood sampling (LABCONCO)
Sample Storage Equipment
- Freezer with a capacity of 200 liters with a temperature of -40?C (Eutra freezer ED-FU 4200)
Sample Processing Equipment
- Vortex mixer
- Roller mixer
- Specially designed small-scale vacuum evaporator
- Analytical balance
- A number of other glassware
Sample Measurement Facilities
- A KNAUER HPLC (UV-Vis detector)
- A JASCO HPLC (UV-Vis detector)
- A Hewlett Packard 1100 HPLC (UV-Vis detector)
- Beckman DU 7500 UV-Vis Spectrophotometer
- A Waters Breeze Gradient HPLC (UV-Vis detector)
- A Hitachi HPLC with UV-Vis (L-7400) and Fluorescence (L-7480) detectors
Dissolution Testing Facility
A USP type dissolution tester (Erweka DT 6) equipped with HP Transport DU 600 and Beckman DU 7500i spectrophotometer.
TESTED PRODUCTS
| No. | Product | Analytical Method |
|---|---|---|
| 1. | Allopurinol Tablets | HPLC-UV |
| 2. | Amoxicillin Tablets | HPLC-UV |
| 3. | Atomoxetine Tablets | HPLC-UV |
| 4. | Domperidone Tablets/ Suppositories | HPLC-FL |
| 5. | Glibenclamide Tablet | HPLC-FL |
| 6. | Glimepirid Tablets | HPLC-UV |
| 7. | Irbesartan Tablets | HPLC-UV |
| 8. | Ketoprofen Capsules/ SR Tablets/ Suppositories | HPLC-UV |
| 9. | Chlorpropamide Tablet | HPLC-UV |
| 10. | Losartan Tablets | HPLC-UV |
| 11. | Metformin Tablets | HPLC-UV |
| 12. | Metronidazole Tablets | HPLC-UV |
| 13. | Lamivudine Tablet | HPLC-UV |
| 14. | Naltrexone Tablets | HPLC-UV |
| 15. | Diclofenac Sodium Tablets | HPLC-UV |
| 16. | Nevirapine Tablets | HPLC-UV |
| 17. | Ondansetron Tablets | HPLC-UV |
| 18. | Pyrazinamide Tablets | HPLC-UV |
| 19. | Piroxicam Tablets | HPLC-UV |
| 20. | Ranitidine Tablets | HPLC-UV |
| 21. | Rifampin Tablets | HPLC-UV |
| 22. | Cefadroxil Capsules | HPLC-UV |
| 23. | Sildenafil Tablets | HPLC-UV |
| 24. | Cylostazol Tablets | HPLC-UV |
| 25. | Ciprofloxacin Tablets | HPLC-UV |
| 26. | Terazosin Tabet | HPLC-UV |
| 27. | Ticlopidine Tablets | HPLC-UV |
| 28. | Zidovudine Tablets | HPLC-UV |
STAFF
| Executive Manager | : Dr. Sukmadjaja Asyarie |
| General Manager | : Prof. Dr. Yeyet Cahyati S. |
| Technical Manager | : Dr. Jessie S. Pamudji, MS |
| Deputy Technical Manager | : Dr. Lucy D.N. Sasongko |
| Administration Manager | : Dr. Lucy D.N. Sasongko |
| Deputy Administration Manager | : Dr. Tri Suciati |
| Quality Manager | : Dr. Heni Rachmawati |
| Deputy Quality Manager | : Tomi Hendrayana, M.Si |
| Medical Responsible Person | : dr. Truli Sitorus, M.Si |
CORRESPONDENCE
Other information and questions can be submitted to:
Bioequivalence Testing Unit
Sekolah Farmasi – ITB
Gedung LABTEK VII, Lt. 3
Jl. Ganesa 10 Bandung 40132
Telp. / Fax : + 62 22 2534125
Email : tri.suciati@fa.itb.ac.id