Dow Institute of Biological, Biochemical & Pharmaceutical Sciences (IBBPS)

The BA/BE facilities of IBBPS are unique in Pakistan as these are located in a medical university which can provide one window services as per WHO and International Council of Harmonization (ICH) and FDA standards.

Bio Equivalence Studies

Bio-equivalence “or “BE” means bio-equivalence phenomenon, according to which two medicinal products containing same pharmaceutical formulation and quantity of the same active ingredient, are considered bioequivalent if they are pharmaceutically equivalent and their bio-availabilities, in terms of rate and extent, after administration in the same molar dose, lie within acceptable predefined limits. The study/asses the Bioequivalence of generic product with the reference product is termed as bioequivalence studies.

Bioavailability Studies

Bioavailability is the fraction of unchanged drug reaching systemic circulation after administration by any route. The assessment of Bioavailability of any product is termed as bioavailability studies.

The BA/BE center comprises of following state of the art section:

VOLUNTEERS HEALTHCARE FACILITY (VHCF):

This facility has spacious room and facilities under the supervision of medical doctors as Clinical Research Coordinators and other delegated study staff. VHCF have following facilities & Services:

• Drug Administration Area. 
• Sample Collection Area.
• Dedicated Informed Consent Area.
• Volunteer Confinement Area: Fully air-conditioned rooms with nurse calling system.
• A well-equipped access-controlled Pharmacy for the storage of investigational drug product.
• Sample processing room equipped with Refrigerated centrifuge, -20 and -80 ultra-low freezers.
• Entertainment Area for entertainment of subjects i.e. equipped with LCD Televisions, indoor games with wi-fi internet access.
• Access control Archive room.
• VHCF is also located in close proximity of fully equipped Intensive Care Unit (ICU).
• Emergency Management room 
• Availability of Ambulance at the study site.
• CCTV camera for 24 hrs. Security and safety

BIOANALYTICAL LAB:

Bioanalytical laboratory of IBBPS is established as per WHO, ICH, DRAP and FDA guidance and ISO 17025 PNAC accredited. The lab is equipped with modern technologies. The equipment of bioanalytical Laboratory are enough capable for accurate Quantitation and Quantification of drug molecules in biological matrices. To ensure the compliance of Good Laboratory Practices in laboratory well-structured quality management system is placed. Bio analytical lab is comprises of following sections:

• Sample receipt desk.
• Plasma Extraction Area.
• LCMS & HPLC Instrumentation lab.
• Wet Lab.
• Chemical storage room.
• Reference Standard storage room.

PHARMACOKINETIC & STATISTICAL ANALYSIS:

• SAS software.
• Red cap for electronic data capturing.

• Report writing.

Dow University of health sciences ojha campus is approved by Drug Regulatory Authority of Pakistan

• General Medicine.
• OJHA Institute Chest diseases.
• ICU and OT complex.
• National Institute of Liver &GI Disease.
• Diabetes & Endocrinology.
• General Surgery.
• Orthopedic.
• Cardiology & Cardiac Surgery.
• Urology & Renal Transplant.
• Oncology.
• Neurosurgery.
• Clinical Hematology & Bone Marrow Transplantation.
• Liver Transplant.
• Head & Neck Surgery.
• Dow Institute of Radiology.

Sindh Infectious disease hospital and research Centre (SIDH&RC) is the only Infectious Disease hospital of Sindh that has outstanding experts and dedicated facilities for the treatment of infectious disease. SIDH&RC is also approved by Drug Regulatory Authority of Pakistan for conduct of Phase 1 to Phase 4 clinical studies.

The facilities available at SIDH&RC are:

• Fully equipped 8 bedded ER on the ground floor.
• 16 bedded ICU-I with ventilator and 34 bedded HDU.
• 1st floor
• 16 Bedded ICU II with 08 ventilator. 
• 2nd floor
• 42 bedded HDU.
• 3rd floor
• 16 Bedded ICU III and 42 Bedded HDU 
• Separate Inform Consent, Area.
• Access and temperature control clinical trial pharmacy. 
• Access control archive room.
• Cold storage area.
• Dow Diagnostic Research and Reference Laboratory (DDRRL)

The Pharmaceutical testing lab of IBBPS is accredited by PNAC ISO 17025. The lab is equipped with all modern technologies and follows WHO, FDA, ICH and GMP guidelines.

The pharmaceutical lab comprises of following sections:

• Sample Receipt Desk.
• Sample Preparation Area
• Wet Chemistry Lab
• Instrumentation Lab
• Chemical Storage Room
• Reference Standard Storage Room

Testing services provided by pharmaceutical lab includes:

• Analysis of Active Pharmaceutical Ingredient
• Analysis of Finished Pharmaceutical Product
• Comparative Dissolution Profile
• Pharmaceutical Equivalence
• Identification Testing
• Impurities Testing
• Analytical Method Development
• Analytical Method Validation
• Analysis of Drug concentration in biological matrices
• Microbiological Testing raw material
• Microbiological testing finished pharmaceutical product. 
• Multimedia dissolution point