Preclinical studies
Preclinical research is carried out by applying scientific methods of evaluation and contributes to the formation of the necessary evidence base for the safety, quality and effectiveness of the product.
The goals of preclinical safety assessment, as a rule, include the establishment of characteristics of toxic effects on target organs, dose dependence, exposure dependence, as well as, where appropriate, potential reversibility. This information is used to determine the initial safe dose and dose range in human studies, as well as to determine parameters for clinical monitoring for potential undesirable effects.
Preclinical studies are a necessary step in registration:
- the original BOS;
- new fixed combination;
- generic, registered in the country of the manufacturer;
- a new original dosage form, a new method of administration, a new indication;
- the presence in the dosage form of excipients that do not have permission for medical use in the Russian Federation
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Selection and evaluation of laboratories for preclinical research
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Conclusion of contracts with laboratories, provision of a base for conducting research
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Preparation of a report on a preclinical study and the formation of a plan for the clinical part of the study
ClinPharmDevelopment
Is an independent contract research organization successfully implementing preparation for and carrying out of clinical trials of all phases within the territory of Russia and EAEU countries.
We employ more than 30 people, including 6 PhD degree holders. All employees involved in trials have a university degree in medicine or pharmacy, GCP/GLP certificates, and broad experience of participating in clinical trials.
The company successfully cooperates with the centers of the Russian Federation for preclinical research that meet all modern requirements, localized in Moscow, St. Petersburg, Yaroslavl."
CPD has received permission from the Ministry of Health of Russia and is starting to conduct the clinical part of the bioequivalence study of a drug used in the treatment of inflammatory and degenerative diseases of the musculoskeletal system, pain syndrome from the spine (lumbago, neuralgia, myalgia,...
CPD employees have prepared a number of protocols and related documents for obtaining permission from the Ministry of Health of the Russian Federation to conduct bioequivalence studies of medicines.
Studies of a nootropic drug used in the treatment of diseases of the central nervous system...CPD has received permission from the Ministry of Health of Russia to conduct bioequivalence studies of a series of drugs.
Medications for the treatment of benign prostatic hyperplasia (dual 5α-reductase inhibitor) for the treatment of benign prostatic hyperplasia, treatment of dysuric disorders...CPD employees have prepared a number of protocols and other documents necessary to obtain permission from the Ministry of Health of the Russian Federation to conduct drug research.
Clinical studies Phase I of the original preparation of the Russian manufacturer, which has pronounced sorption...
A series of reports on completed clinical trials of bioequivalence of drugs was prepared in a short time.
Drugs highly selective direct factor Xa inhibitor, two dosages; contraceptive combination drug (two studies); an antidepressant used in the treatment and prevention of depression...The report of the phase III study of the Russian drug for the treatment of patients with COVID-19 was prepared and finalized in a short time.
This drug is intended for the treatment of a wide range of viral infections and is a purine nucleoside that acts as a competitive inhibitor of viral ...
CPD has prepared a protocol for a phase 3 study of a promising broad-spectrum drug used in the treatment of patients with coronavirus infection (COVID-19) of moderate and severe forms as part of standard therapy.
After the approval of the Ministry of Health of the Russian Federation, CPD will...
The recruitment of patients to phase III studies of a Russian drug for the treatment of patients with COVID-19 has been completed ahead of schedule.
This drug is intended for the treatment of a wide range of viral infections and is a purine nucleoside that acts as a competitive inhibitor of...