Center for Bioequivalence Studies and
Bioassay Research (CBSBR)

PROFILE

Associated with world renowned Research Centers PCMD and HEJ the establishment of "Center for Bioequivalence Studies and Bioassay Research" (CBSBR) was initiated in October 2006 to provide state of the art facility for in-vitro and in-vivo evaluation of generic pharmaceutical products. The total cost of the project is Rs. 250 Million. Prof. Dr. Tasneem Ahmad a well known scholar and the pioneer of BE studies in Pakistan is leading the Center. Consultants from USA, Canada, Germany, Jordan have remained engaged in designing and developing this Center. The center is first of its kind in Pakistan and its working is based on technology transfer.

An appropriately and purposefully designed building on an area of more than 40,000 sq ft. is in the construction phase, planned to be completed by September 2009.

This building will include a full scale clinical research facility accommodating 112 beds, Drug testing Laboratories with state of art Instrumentation, Corporate offices. While the construction work is in progress the admin offices and laboratories are housed in the premises of PCMD and HEJ- the components of ICCBS; a regional center for WHO which is ISO 9001-2000 certified.

OUR SERVICES

• Study Design & Protocol Writing
• Research Subjects Recruitment
• Submission to Ethics Committee for Ethical Approval
• Bioequivalence Study Execution
• Trial and Site Management
• Safety Monitoring
• Storage of Biological Specimens
• Bio-Analytical Method Development and Validation
• Data Management, PK/PD and Biostatistical Analysis
• Final Report Write-up.
• GLP, GCP and Quality Assurance Audits
• Study Monitoring
• Dossier Preparation and Submission.
• Testing of Drug-abuse
 

OUR STRETAGIC ALLAINCE

CBSBR has strategic alliance with "Pharmaceutical Research Unit", a leading CRO of jordan. PRU has 15 years of experience in Bioequivalence Studies and have performed more than 200 studies. We have an understanding through which studies are performed with mutual quality assurance program. We have a program of exchange of experts and technology.

QUALITY ASSURANCE

The constant vigilance by highly competent quality assurance managers and strict following of excellent Standard Operating Procedures ensure authenticity, quality and excellence in Bioequivalence Studies at CBSBR. We see documentation as a crucial step in the process of providing submission to the appropriate governmental and regulatory authorities. We have expert GCP and GLP inspectors for routine inspections.

EXPERT DEDICATED TEAM

An organized and competent team of CBSBR consists of pharmacists, doctors, chemists, statisticians, IT personnel, quality assurance and business managers, who are all dedicated professionals committed to excellence, other staff are associated on part time basis like nutritionists, phlebotomists, nurses etc.

The team is highly qualified and trained from the recognized CRO of Jordan 'Pharmaceutical Research Unit'. The team has also gone through an extensive training under the guidance of trainers from America, Germany, Canada, Jordan and Geneva. .

Our team is expert in conducting clinical trials, bio-analysis, writing protocols and producing comprehensive reports, in compliance with regulatory guidelines, being ethical but conscious to maintain at the maximum the interests of the sponsors with regard to the interpretation and application of the study results.

TECHNICAL AND REGULATORY

Technical and Regulatory department is well versed with national and international guidelines and requirements of BE studies especially of US-FDA, EMEA and WHO.

The technical team working in T&R is expert in preparing protocols, processing them through ethical committees and Ministry of Health, Pakistan and compiling report as per official guidance. Team consists of expert Pharmacists, Pharmacokineticist, Biostatisticians and IT personnel. The state of art computing technology and softwares are employed in all mathematical and statistical evaluations.

CLINICAL FACILITY

Clinical research facility (CRF) designed in such a way that maintains GCP-ICH requirements and consists of:

• Volunteers' accommodation facilities
• Changing room for human subjects
• A recreational area equipped with internet and other facilities
• A television lounge.
• Drug administration room
• Sample collection rooms
• Sample processing facility with refrigerated centrifuges
• Sample storage facility at -25 and -80o C
• Well equipped ICU and ambulance
• A self contained kitchen and Dining Hall

We have a strict and unbiased volunteers’ recruitment program that arranges volunteers with all necessary precautions safeguarding the Ethical issues.

LABORATORY FACILITIES

Bio-analytical laboratory complying with GLP and ISO/IEC-17025 standards is equipped with state-of-the art instruments. All equipments are strictly qualified as per IQ/OQ protocols and validated. We have strict maintenance and calibration program.

The state of art instruments include LC-MS-MS, A series of latest automated HPLCs, Vacuum manifold for solid phase extraction, -80 ºC Freezers , high speed centrifuges, well equipped wet lab for liquid-liquid extraction etc.

Fully integrated computer soft-ware systems to save the data and generate reports complying with 21 CFR US-FDA requirements.

 

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