International Bio Service Co., Ltd., affiliate with Mahidol University, opened a clinical site to provide a complete service of bioequivalence study with international standard quality system.
On Wednesday, March 15, 2023 at 10:00 am, Clinical Professor Emeritus Piyasakol Sakolsatayadorn, M.D., Chairman of Mahidol University Council, and Prof. Banjong Mahaisavariya, M.D., President of Mahidol University honored to preside over the opening ceremony of a clinical site, International Bio Service Co., Ltd., on the 4th floor of the Golden Jubilee Medical Center, Faculty of Medicine Siriraj Hospital Mahidol University, Salaya Campus.
Associate Professor Dr. Juthamanee Suthisisang, Vice President, Mahidol University as the Chairman of International Bio Service Co., Ltd. reported that International Bio Service Co., Ltd., affiliate with Mahidol University, was established in 2005 with the aim of providing a full range of services in bioequivalence study research that meets good clinical research standards (Good Clinical Practices (GCP)) and laboratory standards (Good Laboratory Practices (GLP)) receiving accreditation for the center of bioequivalence study research from the Food and Drug Administration (FDA) of Thailand and other countries, for example, the National Pharmaceutical Regulatory Agency (NPRA) from Malaysia to increase access to good quality generic medicines at affordable prices with comparable efficacy to the high-priced foreign pharmaceutical products. In addition, this also helps promote the pharmaceutical manufacturing industry in the country as well.
Bioequivalence study is a comparative study of drug levels in the blood after healthy volunteers received the original and generic drug, which contained the same type and amount of the active ingredient by conducting under good clinical practice and under good laboratory practice for drug level analysis in the plasma according to international standards. The drug levels from both products were then analyzed for pharmacokinetic values and statistical analysis to determine whether the original drug product and generic drug are bioequivalent and can be used interchangeably or not. Then, this information will submit to the Food and Drug Administration for drug registration as a new generic drug. Consequently, the patients have access to good quality medicines with affordable price as the expensive new drug.
To have a clinical site be able to support healthy volunteers to participate in bioequivalence study, the company has therefore improved the area on the 4th floor of the Golden Jubilee Medical Center, Faculty of Medicine Siriraj Hospital Mahidol University that can accommodate a maximum of 64 beds according to the standards of Good Clinical Practice (GCP). The renovation of the clinical site was completed on August 31, 2022, with great cooperation and support from Mahidol University and Golden Jubilee Medical Center, Faculty of Medicine Siriraj Hospital, Mahidol University.
The opening of this clinical site is to demonstrate the potential and readiness of the company. In line with the vision of ‘Become a World-Class Bioequivalence Center for Generic Drugs’, it aims to become a global bioequivalence center for generic drugs as well as being consistent with the mission by focusing on being an excellent bioequivalence study center with full cycle as one stop services for pharmaceutical companies both local and abroad. The company supports research sponsors in the bioequivalence study of generic drugs with standard quality system, scientific, ethical and good clinical research principles. In addition, applying state-of-the-art technology in operation as well as providing good services with accuracy and reliability is worthy for sponsor’s investment in a timely manner. Moreover, it also focuses on being a partnership of success with pharmaceutical companies to develop good quality generic medicines for patients.
Dr Porranee Puranajoti, Managing Director of the company, said that International Bio Service Co., Ltd. is opened for the service offering appropriate research design, safe and correct research study conduct according to the types of drugs. After preparing protocol and receiving approval by the Ethics Committee, the company begins screening subjects for participation in the research with a team of medical professionals and nurses to ensure the safety of subjects throughout the study period. Blood samples from volunteers will be analyzed for drug levels in the company’s laboratory which has been certified for Good Laboratory Practice (GLP). Drug level analysis will be performed with sophisticate equipment to obtain accurate, reliable research data leading to pharmaceutical analysis results in order to further calculation for pharmacokinetic parameters and statistical analysis as well as standard research reports. There are quality assurance (QA) and quality control (QC) in a systematic audit in order to assure the international quality standards and focus on continuous improvement. As a result of the development of the Company’s potential, the Company has been accepted and trusted including building confidence and credibility with leading organizations, pharmaceutical companies both local and abroad. The company is committed to developing systems and methods for better research studies in order to be further accepted worldwide.
information from : https://www.nationthailand.com/pr-news/more/pr-news/40025754
