หน่วยบริการการศึกษาชีวสมมูลของผลิตภัณฑ์ยา (Bioequivalence Unit)
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เป็นหน่วยงานที่จัดตั้งขึ้นเพื่อให้บริการศึกษาชีวสมมูลของผลิตภัณฑ์ยาแก่หน่วยงานภายนอกทั้งภาครัฐและเอกชน โดยที่หน่วยงานนี้อยู่ภายใต้การกำกับดูแลของภาควิชาเภสัชวิทยา คณะแพทยศาสตร์ มหาวิทยาลัยขอนแก่น การดำเนินการและการบริหาร จะกระทำตามหลักวิชาการ โดยไม่มีผลประโยชน์ร่วมใดๆกับผู้รับบริการ โดยที่ทางหน่วยได้เปิดให้บริการการศึกษาชีวสมมูลมาตั้งแต่ปี 2543 และมีความมุ่งมั่นที่จะพัฒนางานให้มีคุณภาพตามระดับมาตราฐานสากล
Background |
BEU is a clinical trial & research unit under the Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Thailand. It was founded in 2000 and has been rapidly facilitated for the demand in clinical trials and researches, in the faculty of Medicine. The unit has been well organized to support clinical conduct particularly in drug bioequivalence. All clinical protocols here are submitted to the Ethics Committee for Human Research, Khon Kaen University, to provide ethical confidence before further processes have been conducted. Our commitment is to provide a world standard quality service to our clients.
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Clinical Facility |
BEU is located in the Faculty of Medicine, Khon Kaen University. Our laboratory procedures and services are conducted in Srinagarind hospital buildings, with a Provincial Mental Hospital as another affiliated research unit. More than 200 healthy subjects, both males and females, have been registered in our Volunteer Bank. This provides both general and specific subjects for any requirement of the trial.
BEU clinical manipulating area is mainly set in Srinagarind hospital, Faculty of Medicine. Most parts are under air-conditioned system, cosy, and can be housed to 28 clinical trial subjects for an overnight stay. Settings of facility are especially suitable for the conduct in Pharmacokinetics, Pharmacogenetics and Bioequivalent studies.
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The equipments in house include refrigerated centrifuge, -70oC freezers with Uninterrupted Power Supply etc. Essential equipments also consist of 2 set of HLPC systems.
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All these facilities are operated in accordance to ICH GCP guidelines, with a group of qualified and experienced CPU nurses and technicians. Life supporting equipments are also essentially provided in each trial. All staff, such as GP Doctors, specialists (depend on studied drugs), pharmacists, nurses, technicians etc, have been trained according to ICH GCP guidelines.
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Research Methods & Trial Specialties
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Under the ICH GCP guidelines, BEU has clinical trial specialties and capabilities to support the conducts of phase I & II clinical trials, as in the followings.
- Bioequivalence Study
- Pharmacogenetics Study
- Pharmacokinetics Study
- Sensitivity testing, drug effect and interactions, etc
Validated methods for determination of plasma concentrations of several drugs such as anti-TB drugs, cephalosporins, clozapine, proton pump inhibitors, sildenafil, meloxicam etc are provided under standard operating procedures (SOP).
Here are the list of bioequivalence studies that have been approved from Thai-FDA.
1. Bioequivalence of 40 mg risperidone orodispersible tablet formulations in healthy Thai volunteers |
2. Bioequivalence of 40 mg atorvastatin tablet formulations in healthy Thai volunteers |
3. Bioequivalence of 40 mg esomeprazole tablet formulations in healthy Thai volunteers |
4. Bioequivalence of 20 mg omeprazole (magnesium) tablet in healthy Thai volunteers |
5. Bioequivaleance of meloxicam 15 mg tablet in heathy Thai volunteers |
6. Bioequivaleance of meloxicam 7.5 mg tablet in heathy Thai volunteers |
7. Bioequivalence of sertraline tablet in healthy Thai volunteers |
8. Bioequivalence and pharmacokinetics study of sildenafil in healthy Thai male volunteers |
9. Steady-state bioequivalence study of clozapine tablet in schizophrenic patients |
10. Bioequivalence of anti-tubercolosis drugs in healthy Thai volunteers |
11. Bioequivalence study of ceftazidime by intramuscular administration in healthy Thai volunteers |
12. Comparative Bioavailability of Two Phenytoin Suspension formulations in Thai Healthy Volunteers |
13. Bioequivalence of 400 mg moxifloxacin tablet in healthy Thai volunteers |
BEU Staff |
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Contact Us |
Bioequivalence Unit (BEU) |
Department of Pharmacology |
Faculty of Medicine, KKU |
123 Mitraparb Road, Muang District |
Khon Kaen, Thailand 40002 |
Tel/Fax: (66) 43-348397 |
Email : wichitt@kku.ac.th |
