Proceeding quickly through the Phase I-II trial to gain proof of concept is an important milestone in your strategy. At KYABRS, we design our early-stage clinical trials so that patients can be expected early. This is an important milestone of hope for patients with unmet needs.
KYABRS has the expertise to help reduce the risk of study design challenges due to inappropriate scientific justification of dosage, confusing safety thresholds and early-stage delays.
We can bring together a team of regulatory, pharmacological and translational medicine specialists for drug dosage, safety selection, and PK / PD evaluation
We help you design a protocol that helps creating the data you need to make decisions. And when you are ready to begin your Early Phase studies our clinics provide a full scope of services.

These services include:

• Phase I, first-in-human.
• Phase IIa, proof-of-concept.
• Clinical PK/PD and pharmacometrics.
• Ethnobridging studies.
• ioanalytical and biomarkers.
• Bioequivalence and biosimilar studies.

Bioeqivalence Study:

Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products.
The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. KYABRS capable to do the bioequivalence study of any dosage form. KYABRS Bioanalytical Laboratories provide method development, transfer, validation, and analysis of biological samples of study volunteer.
Data analysis for the confirmation of bioequivalence is performed using industry-standard WINNONLIN® software