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Preclinical Studies for Drug Registration in Russia
Current Russian regulations require quite comprehensive preclinical study program for every pharmaceutical submitted for state registration. Preclinical study report in any case should contain following points:
- Acute toxicity study
- Subacute and/or subchronic toxicity study
- Local tolerance study
- Specific preclinical studies depending on product class
One should keep in mind that for generic products or biosimilar those studies should be comparative vs original product.
It is not obligatory to conduct that set of preclinical studies in Russia, nevertheless most applicants conduct such studies locally with help of experienced CRO in Russian centers. The reason is simple – like for clinical studies there are MoH-approved guidelines for conduction of preclinical study for majority of clinical pharmacology product classes, specific requirements in normative regulatory base as well as locally established GLP standard in Russia.
Our specialists has extensive experience in managing preclinical studies in Russia with contacts in all GLP-compliant study centers in Russia. We would be glad to help you with fast and free calculation of preclinical study budget and timeline. Also our consultation concering conduction of preclinical studies for registration and available options to choose will be granted to you. Our experts will discuss every details of your project and in any case you will receive working solution that will bring you clear picture to proceed with your project safely.
Registration of biopharmaceutical drugs in Russia
assumes quite complex set of activities. Due to strict and spedific regulatory requirements in Russia to biopharmaceuticals e.g. biosimilar products, in particular, completed preclinical studies program that is needed in frames of registration dossier for a biopharmaceutical product can be much more sophisticated and challenging than set of standard tests for an original “traditional” pharmaceutical.
Depending of type and clinical pharmacology class of biopharma product its preclinical programs should have following studies:
- Pharmacodynamics - in vitro and/or in vivo
- Pharmacokinetics - in vitro and/or in vivo
- Immunogenicity
- Immunotoxicity
- Safety pharmacology for key systems of organs
- Reproductive toxicity
- Cancerogenicity
- Mutagenicity
- Drug interaction safety
- Other specific studies
Specific preclinical program is required for registration of new vaccines in Russia.
For biotechnological medicines like monoclonal antibodies, recombinant protein-based pharmaceuticals and other product produced by cell lines, it is needed to present quality confirming documents for every stage of cell bank growth and purification as well as every source material used in biotechnological manufacturing.
Our experts have comprehensive experience in managing and conduction of preclinical studies programs for biopharmaceuticals in various GLP-compliant centers all over Russian Federation. Also we can analyze your existing preclinical studies portfolio, advising best way to handle specific studies missing for registration in Russia.
We provide fast and free calculation of your preclinical program budget and timeline. Send us your request or simply call us and our experts will discuss every detail of your project with you and you will receive working solution that will bring you Clear Regulatory Answers for your business.
In Vitro Preclinical Studies in Russia
are commonly used for several procedures like addition of new dosage (that require new registration procedure)
- Biowaver testing (test of comparative dissolution kinetics of drugs) for every dosage of a pharmaceutical to be registered;
- Comparative studies of antibiotic activity;
- Microbiology studies;
- Viral safety studies;
- Additional pharmacokinetic variables assessment as part of a clinical study;
- Patient genotyping for highly-variable metabolism pharmaceuticals in frames of bioequivalence or therapeutical equivalence studies;
- Pharmacogenetic studies.
Contact us today and we provide you free calculation and initial consultation on in vitro study budget and timeline. Our experts will discuss every detail of your project and you will receive working solution that will bring you Clear Regulatory Answers for Your Business.