Products and Services. Pharmacokinetics and Bioequivalence Studies

The Institute of Biotechnology and Antibiotics carries out pharmacokinetic studies of drugs. This is done for purely scientific purposes or as contracted services. The IBA works closely with other scientific and research establishments, and also with the pharmaceutical industry. The services provided to pharmaceutical companies include research activities required for drug registration such as early phase clinical trials or bioavailability and bioequivalence studies. Comprehensive services or a selected array of services can be offered, depending on the project and customer requirements.

The services are provided by the interdisciplinary team comprising of the specialists of the Scientific and Medical Information Department and the team of the Pharmacokinetics Laboratory of the Chemical Analysis Department.

The standard services include:

• Research subject examination from a scientific view point (determination of objectives and methods, and research feasibility)
• Development of research curricula for different medicinal substances and pharmaceutical forms
• Design of specific research and project consultations
• Development of research protocols in line with the international standards
• Assistance in choosing an appropriate clinic
  
• Performance of the complete bio-analysis as per the GLP:

• development of drug determination method in the received biological material
• validation of the method
• sample preparation (including initial processing at the place of collection, if needed)
• determinations (mostly by in-house methods)
• drafting analytical reports in line with the international laboratory standards and customer requirements
• Content-related processing of research results:
  • calculations and pharmacokinetic analysis
  • statistical analysis and inference (SAS)
• Drafting a comprehensive final report (in the Polish or English language) to include general, clinical, analytical, pharmacokinetic and statistical sections, in CTD-compliant format.

The IBA team also provides assistance, on an as needed basis, in the interpretation of research results, consultations in respect of the documentation to be submitted for registration as well as performs expert evaluations and issues opinions concerning the scope of the bioavailability and bioequivalence studies.

The principal qualities of the IBA team are:

• Modern tools for pharmacokinetic and statistical processing of the results as recommended by the regulatory agencies (inter alia  SAS 9.1.3 Personal Analytics, Kinetica).
• Highly experienced personnel with a long scientific service in or associated with pharmacokinetics, drug testing and organization of bioavailability and bioequivalence studies (team members are joint authors of a book in this field).
• The laboratory with state of art equipment and facilities, operating in line with the GLP to assure the highest quality of analytical determinations.
• Excellent knowledge of the European guidelines and international standards and being versed in the current scientific developments in pharmacokinetics of drugs.
• Application of a lateral approach to each and every project, and scientific scrutiny in troublesome cases.

For any of these services please contact:

The Scientific and Medical Information Department
Monika Bogiel
phone: +48 (22) 37 86 131
mail: bogielm@iba.waw.pl

Monika Pawłowska
phone: +48 (22) 37 86 133
mail: pawlowskam@iba.waw.pl

The Pharmacokinetics Laboratory of the Chemical Analysis Department
Jolanta Duda
phone: +48 (22) 37 86 144
mail: dudaj@iba.waw.pl