Center for Bioequivalence Studies and Bioassay Research (CBSBR)
The ‘Center for Bioequivalence Studies and Bioassay Research’ (CBSBR) is the first contract research facility being established in the country for evaluation of generic pharmaceutical products with the faith that all “human beings have equal worth; their lives are equally valuable; and they deserve equal respect”. The center associated with PCMD was established in 2006 in ICCBS. Higher Education Commission gave administrative approval to this center in March 2007 with a promise of providing Rs. 249.13 Million as seed money, after its completion in three years it will be a self sustained nucleus of biomedical and pharmaceutical research of both commercial and academic nature.
With continuous hard work and cooperation of consultants and advisers from America, Germany, Canada, Jordan, Geneva and consultants available at home a dedicated expert team has been prepared capable of taking the task of bioequivalence testing. This team is capable of conducting clinical trials, analysis of body fluids, performing statistical and pharmacokinetic analysis for BE studies, monitoring and assuring GCP and GLP and capable of handling all ethical and regulatory issues. The team consists on pharmacists, doctors, chemists, statisticians, IT personnel, quality assurance and business managers besides a lot of other peoples associated on part time basis like nutritionists, phlebotomists etc.
While the building is under construction, a bioanalytical laboratory fully complying ISO-17025 and GLP has started working along with a clinical research facility (CRF) capable of accommodating 24 patients/volunteers has started functioning. Clinical trials are conducted in CRF as per GCP requirements in cooperation with German and Jordanian consultants. Bioanalytical laboratory for drug molecules and metabolites in body fluids has a battery of seven analytical HPLCs with all necessary equipments for drug extraction from body fluids and its storage and handling as per GLP.
Besides a good team of experts, a state of art Bioanalytical lab the center also has a bioassay lab, a well structured documentation system and collection of literature. The center has started conducting commercial studies with cooperation of ‘Pharma Research Unit’ of Jordan.
An appropriately designed building is in the construction phase envisaged to complete by 2010. This building is being constructed on 32,000 sq ft. will include a full scale clinical research facility, laboratories, corporate offices and teaching facilities. Consultants and experts of international repute from Europe, Asia and WHO are contributing in terms of expert advice and training of the human resource.
On its completion this center will provide bioequivalence testing facility to national and multinational pharmaceutical industries operating in the country as well as to else where in the world. Besides an accredited drug research center with international regulatory agencies, the CBSBR will work as a third party drug testing laboratory and a premier research and teaching facility for Biopharmaceutics, Pharmacokinetics, Clinical Trials, Bioanalytical Method Development, Biostatistics, Bioassay and Documentation leading to Good Laboratory and Clinical Practices.
Prof. Dr. Tasneem Ahmad
Project Director of CBSBR
B. Pharm., M. Pharm., Ph.D.(Pharmacokinetics)
Ex Chairman of Pharmaceutics, Faculty of Pharmacy,
University of Karachi
Ex. Chief Executive of ‘Pharma Professional Services’Published over 20 research papers on Bioequivalence, Pharmacokinetics and Biostatistics. Edited five books on Quality Assurance, Herbal Medicines and Drug Information. Organized international conferences and workshops on Quality Assurance of Pharmaceuticals. Designed and developed software systems for BA/BE and PK/PD studies. Prof. Tasneem is editor of annual publication ‘Current Drugs and Pharmaceuticals’ and www.druginfosys.com; an Online Drug Information System.
Area of Research:
Pharmacokinetics, Biostatistics, Clinical Trials, Drug Interactions
Dr. Panjwani Center for Durg Molecular Medicine and Drug Research ,International Center for Chemical and Biological Sciences , University of Karachi, Karachi-75270 Pakistan. E-mail: info@iccs.edu; hej@cyber.net.pk, UAN: 111-222-292, Ph:(+92-21) 4824925, 4824924, 4819010, 4824934,4824901,4824930 Telefax: (+92-21) 4819018,4819019
