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Preclinical trials:
     Development of biologically active substances (BAS) production technology
    Technological works on finished products
       Clinical trials
  • phase I
  • phase II
  • phase III
  •  phase IV
  • Comparative bioequivalence studies
         Registration of BAS and medicinal preparations
  • Development of a medicinal preparation Master File
  • Carrying out a registration procedure
    Drugs, biologically active substances, and food supplements patenting
     
Development and registration of biologically active food supplements
  • Professional design of a biologically active food supplement composition according to a client’s requirements
  • A biologically active food supplement preclinical trials
  • Development of a biologically active food supplement production technology
  • Clinical trials
  • Pilot samples production
  • Development of a medicinal preparation Master File for its subsequent registration
  • Registration of a biologically active food supplement
  • Production of a biologically active food supplement in compliance with a contract concluded
           ИФАР (Инновационные фармакологические разработки)
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Overall solutions for drugs and biologically active food supplements production
  

Development and patenting of a generic drug
  

Development of a generic drug equivalent to a selected prototype
  

   

Development of drugs possessing prolonged action
  

Development of sublingual drugs
  

Development of liquid medicinal preparations based on a poorly soluble substance
   

Unique professional solutions of unconventional tasks in compliance with marketing specialists requirements
  

Development of a medicinal preparation Master File in compliance with European Pharmacopoeia.
  

Pre-clinical trial studies

     

Screening

The purpose of pharmacological activity screening is to reveal the capacity of a new compound or mixture (of synthetic or natural origin) to affect essential systems and organs in normal or pathological conditions.

Special experimental models are used for screening. In some cases the animal model (in vivo) is used for pharmacology screening, but the most preferable experimental system is the in vitro system, using cell or tissue cultures. In vitro studies have the following advantages:

  • allow quick assessment of biological activity of multiple compounds in different dosages
  • high standardization/reproducibility, since cells are grown in standard conditions, minimizing the difference of reactions to external factors
  • high sensitivity, since every specific study uses the most feasible model
  •  in vitro methods allow to use human cells, minimizing the risk of negative results in subsequent clinical trials, since results obtained in animal material aren't always transferrable to human organism
  • use of cell cultures allows to detail the possible mechanism of action of the test compound much better than in vivo methods

Screening allows to make a decision on the feasibility of further studies of the compound in animal studies, which are far more expensive than in vitro studies, and also to select the best (most effective and least toxic) compound out of several analogs. Screening results determine the plan of further studies of the prospective drug. 

     

 

Safety Study

Safety stuies ars carried out to reveal negative effects of new API or drugs. They allow to determine the possible use of an API as a drug, its side effects, counterindications and dose range.

Safety studies are carried out at special animal facilities in strict adherence to the regulatory requirements (Pharmacological Committee of Russian Federal Service for Supervision of Public Health and Social Development).  The extent of a safety study is based on the samples' properties and suggested indications for use of the drug.

A report on drug safety research is a part of the Drug Master File for drug registration.

 

 

 

Pharmacological activity extended study

Extended studies of pharmacological activity are carried out in laboratory animals or/and in cell cultures at specialized laboratories in strict adherence to requirements of the Pharmacological Committee of Russian Federal Service for Supervision of Public Health and Social Development.

The purpose of extended studies is to show the mechanism of action of the drug  The volume of extended studies is depended on API properties as well as intended indications for clinical application of the drug.

Extended studies of pharmacological activity allow us to detail not only the theorized main effect but also additional pharmacological effects of the drug.

The report on extended studies of pharmacological activity is a part of the Drug Master File for drug registration.

     

Pharmacokinetics

Pharmacokinetics research is carried out in order to study drug absorption, distribution, metabolism and excretion. Such studies are necessary for a new drug with one active ingredient or for complex drug with the main active ingredient detected.

Pharmacokinetics research results are used as a basis of a drug dosage regimen and their usage in clinical practice.

Pharmacokinetics research is carried out in experimental animals in specialized laboratories in strict adherence to requirements of the Pharmacological Committee of Russian Federal Service for Supervision of Public Health and Social Development.

A report on pharmacokinetics study is included in the Master File submitted for drug registration.

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