Center for Bioequivalence Studies and
Bioassay Research (CBSBR)
at the
PCMD

PROFILE

Associated with a world renowned Research Center (PCMD), 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. Prof. Dr. Tasneem Ahmad, a well known pharmacist and the pioneer of BE studies in Pakistan, was invited to lead the establishment of the new center. Consultants from USA, Canada, Germany, and Jordan were engaged in the designing and development of this new center. The center is first of its kind in Pakistan and its function is based on technology transfer.

An appropriately and purposefully designed building on an area of more than 40,000 sq ft. has been constructed for CBSBR.

This building includes a full scale clinical research facility, accommodating 112 beds, drug testing laboratories with state-of-art instrumentation, documentation and MIS section and corporate offices. Some of the analytical facilities are also housed in the premises of parent institution PCMD, a component of the ICCBS; which is a regional center of WHO and ISO 9001-2000 certified.

SERVICES OFFERED

• Study Design and Protocol Writing
• Research Subjects Recruitment
• Submission to Ethics Committee for Approvals
• 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
• Any other need-based service, on demand
 

OUR STRETAGIC ALLAINCE

The CBSBR of PCMD has strategic alliance with the "Pharmaceutical Research Unit" (PRU), a leading CRO of Jordan. PRU has a decades of experience in bioequivalence studies and have performed more than 200 studies for leading companies. We have an arrangement through which studies are performed with mutual quality assurance program. We also have a program of exchange of experts and technology between the two organizations.

QUALITY ASSURANCE

The constant vigilance by highly competent quality assurance managers and strict adherence to excellent Standard Operating Procedures ensure the authenticity, quality and excellence of bioequivalence studies conducted at the CBSBR. The CBSBR has quality documentations as crucial step in the process of providing BE reports for 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 consists of pharmacists, medical doctors, chemists, statisticians, IT personnel, and quality assurance and business managers, who are all dedicated professionals, committed to excellence. Other staff are associated on part time basis, such as nutritionists, phlebotomists, nurses, etc.

The technical and MIS 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 USA, Germany, Canada, Jordan, and Switzerland.

The CBSBR 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 of CBSBR 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 other agencies such as Ministry of Health of Pakistan,WHO, etc. The state-of-the-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 -80 °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 and personal rights.

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 validated as per IQ/OQ protocols. We have also implemented strict maintenance and calibration programs at the CBSBR.

The state-of-the-art instruments include, LC-MS-MS, a series of latest automated HPLCs, Vacuum manifold for solid phase extraction, -80 ºC freezers, high speed centrifuges, and well equipped wet labs for liquid-liquid extraction.

Fully integrated computer soft-ware systems to store the data and generate reports complying with 21 CFR US-FDA requirements also exists at the CBSBR.

 

Prof. Dr. Tasneem Ahmad
Project Director, 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. Ahmad is an editor of annual publication ‘Current Drugs and Pharmaceuticals’ and www.druginfosys.com; an Online Drug Information System.

His area of research includes, Pharmacokinetics, Biostatistics, Clinical Trials, and 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