Bioequivalence

QBIO conducts the full range of bioequivalence studies, from simple to replication, including clinical trials with patients.

Over the past 5 years, we have been the leader in Russia in the number of clinical bioequivalence studies conducted.

Clinical bioequivalence studies are conducted on the basis of the Pharmacokinetic and Pharmacodynamic Research Centre, which combines medical departments, a chemical analysis laboratory, scientific and biostatistical groups.

Based on the Pharmacokinetic and Pharmacodynamic Research Centre, it is possible to conduct turnkey clinical bioequivalence trials:

clinical, analytical, biostatistical and writing services.

Thanks to a unified quality management system at all stages of the study, including a unified system for handling biospecimens, we ensure high reliability of the results obtained, which influence the assessment of bioequivalence of the compared drugs.

We have experience in conducting clinical bioequivalence studies based on pharmacodynamic parameters:

Ointment forms of corticosteroids in healthy volunteers with assessment of pharmacodynamic parameters by the modified Stoughton-McKenzie vasoconstriction method using hardware chromametry;

Antacids in healthy volunteers with evaluation of PD parameters by the method of 24-hour pH measurement.

We have a license to circulate narcotic drugs, psychotropic substances and their precursors, and therefore we conduct clinical trials of this class of drugs.

The database of the Pharmacokinetic and Pharmacodynamic Research Centre consists of:

3 inpatient units with 70 beds

2 intensive care units

Chemical analysis laboratory

Local clinical diagnostic laboratory

2 clinical bioequivalence study units

Research Department

EXPERIENCE

To date, we have conducted more than 180 phase bioequivalence clinical trials.

In total, more than 7,000 people have been involved in these trials.

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ON CENTRE-BASED RESEARCH

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Bioequivalence clinical study with INN Escitalopram

SUBJECTS: 20 (healthy volunteers)

RECRUITMENT DURATION: 2 weeks

RECRUITMENT DURATION: 6 months

Peculiarities: Based on the Pharmacokinetic and Pharmacodynamic Research Centre, two turnkey clinical trials of the drug with INN Escitalopram were conducted. Our research team developed an initial package of documents for submission to the Ministry of Health of the Russian Federation, completed the clinical and analytical part of the trial, and subsequently prepared statistical and final reports. Based on the results obtained, the study drugs were successfully registered. It should be noted that the turnkey project was completed in only 6 months. The client was satisfied not only with the results of the project, but also with the deadlines and, most importantly, with the ‘optimised budget’.

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Clinical study of biosimilar product with INN Dabigatran

SUBJECTS: 74 (healthy volunteers)

RECRUITMENT DURATION: 2 weeks

RECRUITMENT DURATION: 4 months

Peculiarities: At the Pharmacokinetic and Pharmacodynamic Research Centre, a 4-period clinical trial of the drug with the INN Dabigatran was conducted with inpatient subjects in a cohort of 46 people. The complexity of the project was the overlap of time points for a number of protocol activities, including PK biospecimen collection points. A solution to this problem was found in the ability to hospitalise subjects in two different units of the Centre, with teams working in parallel using a single synchronised time.

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Clinical pharmacodynamic equivalence study using 24-hour pH measurement

SUBJECTS: 12 (healthy volunteers)

RECRUITMENT DURATION: 4 weeks

RECRUITMENT DURATION: 3 months

Peculiarities: At the Pharmacokinetic and Pharmacodynamic Research Centre, a clinical study was carried out to determine the pharmacodynamic equivalence of the drug with the INN Magaldrat. The complexity of the project lay in the methodological characteristics of 24-hour pH measurements and their invasiveness. A strict selection of subjects was required, also based on the results of fibrogastroduodenoscopy. The successful implementation of this project was made possible by the presence of an endoscopy department and a 24-hour pH measurement room in the Pharmacokinetic and Pharmacodynamic Research Centre, as well as the involvement in the implementation of this project of a specialized research team with experience in performing the above-mentioned diagnostic procedures.

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WHY IT PAYS TO WORK WITH QBIO

EXPERIENCED RESEARCH TEAM

> 25 principal investigators >50 co-investigators 25 nurses 5 coordinators

EXTENSIVE DATABASE OF HEALTHY VOLUNTEERS

More than 15,000 people in the database

FAST SUBJECT RECRUITMENT

And the possibility of hospitalization in large cohorts (70 persons)

AVAILABILITY OF ANALYTICAL STUDIES

Ability to perform analytical studies using non-standard methods

TURNKEY PROJECT OPPORTUNITY

Ability to deliver a turnkey project from protocol to final report

FAST AND EFFICIENT COMMUNICATION

with clients through the use of our own digital services for the management of clinical trials

HIGH QUALITY DATA

and quick data entry in the eCRF (Electronic Case Report Form)

TIME AND DEADLINES

Short project completion times

REGULATORY COMPLIANCE

Compliance of all processes with Russian and international regulatory authorities.

MEDICAL LICENCES

for > 35 medical specialties and for carrying out activities related to the circulation of narcotics, psychotropic substances and their precursors

Bioequivalence

Bioequivalence

Based on the Pharmacokinetic and Pharmacodynamic Research Centre, it is possible to conduct turnkey clinical bioequivalence trials:

We have experience in conducting clinical bioequivalence studies based on pharmacodynamic parameters:

The database of the Pharmacokinetic and Pharmacodynamic Research Centre consists of:

EXPERIENCE

SERVICE PACKAGE

Bioequivalence clinical study with INN Escitalopram

SERVICE PACKAGE

Clinical study of biosimilar product with INN Dabigatran

SERVICE PACKAGE

Clinical pharmacodynamic equivalence study using 24-hour pH measurement

SERVICE PACKAGE

WHY IT PAYS TO WORK WITH QBIO

EXPERIENCED RESEARCH TEAM

EXTENSIVE DATABASE OF HEALTHY VOLUNTEERS

FAST SUBJECT RECRUITMENT

AVAILABILITY OF ANALYTICAL STUDIES

TURNKEY PROJECT OPPORTUNITY

FAST AND EFFICIENT COMMUNICATION

HIGH QUALITY DATA

TIME AND DEADLINES

REGULATORY COMPLIANCE

MEDICAL LICENCES

CONTACTS US

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