According to different sources the share of generic drugs on Russian market is up to 75-90%. Therefore, bioequivalence studies are of great pharmaceutical, economic and clinical value. Drugs of this type are much more accessible to the population of Russia, but they certainly need to meet the same standards of quality, safety and efficacy as the original drugs.
Since so called “Federal Law 61” came into force the main requirement for the registration is to determine the bioequivalence of generic drugs after complete cycle of preclinical studies conducted on the territory of the Russian Federation. Since generic drugs must be a substitute for each other without additional therapeutic monitoring and no dose adjustment required for identical indications.
NADIM CRO proposes to organize and carry out your bioequivalence studies of generic drugs and biosimilars. We will assist you during the whole cycle of the study, starting with preparation of study documentation and until submission of the study report.
Experienced staff of our company will effectively perform the following work:
• Select effective fast running study site;
• Develop all necessary documents for submission and study registration at RF MoH, such as IB, ICF, study protocol, paper CRF; NADIM also provides development of eCRFs.
• Pre-submission control of documents at regulatory bodies to avoid rejections;
• Organization of insurance for volunteers involved in the trial;
• Conducting of monitoring visits and audit at clinical sites;
After creating a study synopsis which is a short document of 8-10 pages it is possible to develop precise study budget with exact detalisation of all costs. After approval of budget by the sponsor all documents necessary for submission will be developed shortly. Usually it takes up to 3-4 weeks.
NADIM also have its own healthy volunteers database for different types of BE studies. During 2012 NADIM successfully conduct 15 clinical BE studies at sites located in Moscow, St. Petersburg, Smolensk and other cities with more than 250 volunteers involved .
The total cost of the study mostly depends on:
1. Pharmaceutical group of test drug (PK properties, drug group, indication for use and mode of action. E.g. cost for the study of TK-inhibitor will be always higher than for NSAID, PK study on patients are more expensive than on healthy volunteers)
2. Cost of comparator drug
3. Number of samples to be collected during study
4. Duration of volunteer participation in the study
5. Payments to investigators and clinic
6. Cost of samples PK analysis (LCMS)
7. Total number of volunteers to be enrolled
Below the main steps of PK study are listed:
• Development of the study protocol with justification of sample size, development of secondary documents (ICF, CRF etc.)
• Site selection, obtaining insurance policy, development and justification of statistical and PK analytical plan, purchase of spare materials and comparator drug.
• Preparation and submission of CTA (Clinical Trial Application) file.
• Obtaining permission for the study (usually it takes 3 month since submission of CTA to get regulatory approval).
• Volunteers recruitment and Site initiation, start of the active phase of the study, PK samples collection and delivery to analytical lab. Monitoring of safety profile of test and reference drug.
• PK samples analysis, statistical analysis of data
• Preparation and verification of clinical and PK parts of final report
• Submission of the report to HA
Setting realistic timing of the study with the optimal balance of cost and guarantees the quality of the data and acceptance of the results by Health authorities.
NADIM CRO has extensive experience in the field of organization of generic drugs PK studies, working with doctors and researchers who are high-level professional, honest, intelligent and responsible people. If you are interested in bioequivalence studies, you can be confident that all work will be done on time with reliable results.
- Pharmacoeconomic studies
- Development of medical documentation
- Medical statistics and translations