Center for development of scientific-research and medical activities
Within the main area of activity of the Drug Development Center (the Center) are research and development initiatives on creation of novel drugs and carrying out applied research in pharmacology.
The laboratory for dosage form development acting within the Center carries out development of both original and generic drugs in various dosage forms.
- oral (tablets, including film-coated tablets; capsules; solutions; syrups; gels);
- injections (ampoules; cartridges; vials);
- topical semi-solids;
- topical solutions.
The laboratory is engaged in development of the drug manufacturing technology, creation of scientific and technical documentation for drugs and technology transfer to the manufacturing site.
The Center also includes the analytical laboratory, where analysis of the developed original and generic drugs is performed using the most advanced instrumental methods. Besides, this laboratory develops new or modifies the existing chemical analytical methods, performs validation, and prepares normative documentation.
The primary objects of studies are active pharmaceutical ingredients, excipients and dosage forms.
The laboratory is equipped with state-of-the-art high-accuracy equipment meeting the standards to guarantee the high level of studies.
Analytical studies area involves the following:
- control of the quality of APIs and drug products against normative documentation;
- development of quality control methods for APIs and drug products;
- analytical method validation for APIs and drug products, preparation of validation protocols and reports;
- stability studies for APIs and drug products;
- incoming control of the quality of raw materials, excipients and reagents;
- control of the quality of intermediates and semi-products obtained within the drug manufacturing process;
- assignment of storage conditions and periods for APIs and drug products.
The goal of the Center is also to secure a high level of projects on creation of novel drugs, including highly professional expert evaluation and administration of projects, from the concept stage through development, pre-clinical, and clinical trials. Within this area of activity, the Center renders the following services:
- Organization and administration of studies for drug developers and manufacturers:
- selection of the best possible investigational center for efficacy and/or safety studies according to the drug profile;
- selection of the best possible investigational center in terms of price/quality aspects;
- on-site assessment of the investigational center for compliance with the specific nature and peculiarities of pre-clinical trials to be executed;
- development of the design for pre-clinical trails, drafting plans together with the investigational center according to the requirements and recommendations of global and national guidances and regulating standards;
- preparation/assessment of supporting documentation and SOPs for conducting studies according to regulating standards;
- initiation and monitoring of pre-clinical trials;
- evaluation of reports on drug product pre-clinical trials;
- evaluation of documentation in support of study reports;
- drafting literature reviews in the CTD format;
- evaluation of literature reviews with all necessary amendments incorporated;
- consultations on pre-clinical trials and project administration up to reports approval by regulatory authorities;
- tentative forecast of the results of pre-clinical trials to be used on the clinical stage.
- Advisory support in preparation of field-specific publications.
- Evaluation of the scientific capability and correctness of documentation included into the registration file (dossier) for drug products (reports on pre-clinical and clinical trials, literature reviews, manufacturer’s monographs, investigator’s brochure, etc.) in case of drug buy and sell transactions.
For the last 5 years, the Drug Development Center has obtained 7 patents, one out of which is a European one, and has published 20 articles in scientific periodicals listed by the Higher Attestation Commission.
The Center actively collaborates with the top universities of the country in training of qualified staff for the pharmaceutical industry. In the laboratories of the Center, students undertake internship, prepare the graduate thesis, and participate in research activities of the Institute.