Bioavailability & Bioequivalence (BA/BE) Studies

Bioavailability/Bioequivalence Services at Pharma Metric Lab are conducted according to GCP and ISO 17025/GLP compliance. Our facilities had been audited by BPOM (Indonesian FDA), National Accreditation Body (KAN) and customers from Indonesia and Malaysia. Our BA/BE report has been accepted by Regulatory Authority in Indonesia, Malaysia and Philippines. Our services comprises of regulatory consulting, protocol design, ethics committee submissions, import license of sample, subject screening and management, method development and validation, data management, statistical analysis and report writing.

BA/BE studies are conducted in house at Pharma Metric Labs or at selected hospital in Jakarta, depending on customer request. Our In house clinical facilities has 40 beds for volunteers located at Central Jakarta, near to hospital. We have a database of over 500 volunteers and have areas for screening, clinics, recreation and dining rooms, as well as pharmacy with emergency medicines.

We have an in-house, GLP-compliant bioanalytical laboratory with an LCMS/MS, UPLC and 2 HPLCs : Waters Triple Quadrapole LC-MS/MS system, Waters UPLC and Alliance Waters. We have developed a library of validated bioanalytical methods that have been used in prior BA/BE studies. At the moment we have 53 bio analytical methods in the wide range of therapeutic areas such as Gastro Intestinal Tract, Cardiovascular, Anti Diabetic, Antibiotic, Anti Fungi, Musculoskeletal, Central Nervous System, Analgesic, Respiratory, Anti hystamine, Health Supplement, etc. Nevertheless, we continuously validate new bioanalytical methods to address a new customer need and anticipate future customer needs.