Bioavailability & Bioequivalence
Bio Equivalence Centre
The BA/BE facilities of IBBPS are unique in Pakistan as these are located in a medical university which can provide one window services of WHO and International Council of Harmonizationa (ICH) standards at DUHS.
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.
Mechanism of Bioequivalence at IBBPS:
The bioequivalence center of IBBPS has following Facilities:
Volunteers Healthcare Facility
This facility could house 26 volunteers in 13 double bed, spacious rooms with attached toilets under the supervision of medical doctors as Clinical Research Coordinators and other delegated study staff.
Volunteer Recruitment
We have a database of volunteers including both genders, Recruitment is continuous for the volunteer pool in CESR (Clinical Eligible Subject Recruitment), a data base.
Facilities Available in Volunteers Healthcare Facilities:
- adequate facilities for complete physical examination and Medical screening to recruit potential volunteers.
- Fully equipped Intensive Care Unit (ICU) with trained staff
- 24 hrs. availability of Ambulance at the study site
- CCTV camera for 24 hrs. security and safety monitoring throughout the trial.
- A well-equipped access-controlled Pharmacy for the storage of investigational drug product at various temperature limits as per their requirements.
- Refrigerated centrifuge for the processing of Subject samples.
- For storage of samples, -20 and -80 ultra-low freezers are present at the facility.
- Fully air-conditioned rooms with nurse calling systems and attached bathrooms
- A hall for entertainment of subjects i.e. equipped with LCD Televisions, indoor games with wi-fi internet access.
Bio Analytical Laboratory
Bioanalytical laboratory of IBBPS is established as per WHO, ICH, DRAP and FDA guidance and 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.
- Quantitation and Quantification of drug molecules in biological matrices
- Method Development and Validation
- Comparative Dissolution Profile
- Multi-Media Dissolution Point
- Pharmaceutical Equivalence Testing
- Quality Control drug testing