The purpose of pharmacological activity screening is to reveal capacity of a new compound or mixture (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 is used for pharmacology screening, but the most preferable experimental system is the in vitro system. In vitro studies makes it possible to quickly and inexpensively draw data about the new compound’s biological properties, to select the best one among analogues and find an optimal dose for in depth research in vivo. Wide screening is the basis for preclinical studies planning.

Safety Study

Safety study is carried out at in-house Animal Facility in strict adherence to the regulatory requirements (Russian Federal Service for Supervision of Public Health and Social Development, OECD, EMA, FDA). Study protocol may be in GLP or non GLP frame. The extent of toxicological research is based on samples properties and suggested indications for drugs application.

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

Extended studies of pharmacological activity are carried out on laboratory animals or/and in cell culture at specialized laboratories in strict adherence to requirements of the Russian Federation Pharmacological Committee.

The purpose of extended studies is to show the mechanism of drug action on the living cell and whole organism at different conditions. The volume of extended studies is depended on API’ properties as well as intended indications for drug clinical application.

Extended studies of pharmacological activity allow us to reveal not only the supposed main but attendant pharmacological effect of the drug.

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

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

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

Pharmacokinetics research is carried out on experimental animals in specialized laboratories in strict adherence to requirements of the Russian Federation Pharmacological Committee as well as EMA, ICH and FDA recommendations.

A report on pharmacokinetics investigation is included in the Drug Master File submitted for official drugs authorization.