Preclinical study of any drug includes a lot of stages allowing to comprehensively learn an active substance and its action on the body, a range of therapeutic doses, possible adverse effects and etc. One of these stages is a pharmacological study of a drug.
Pharmacological studies of drugs
This part of studying the drug suggests the determination of its pharmacokinetics and pharmacodynamics. The first notion means an investigation of the processes occurring with the drug in the body:
- Absorption rate using different ways of administration;
- Distribution of the substance in the body, its affinity to certain organs and tissues;
- Biochemical changes of the substance;
- Ways of drug excretion from the body;
- Excretion time of the drug.
These data of pharmacological studies of drugs are very important because they largely determine the means of drug administration to a human, doses, and also the sphere of drug application (for treating pathology of defined organs and systems).
Another important component of pharmacological studies of drugs is determination of its pharmacodynamics. This notion includes the drug action on biological organisms:
- Parasites (bacteria, viruses, fungi, protozoa, helminths, insects and etc.).
This part of the studies allows to identify therapeutic effects, adverse action and also a dependence of the substance action on the body from its concentration. In a first step, all pharmacological studies are carried out in animals to study the drug safety for human health, and only when all necessary data obtained, clinical trials may start.
All animal studies are carried out according to the recommendations and the government instructions concerning the use of laboratory animals:
- National state standard GOST P 33044-2014 the Russian Federation standard “The principles of Good Laboratory Practice” ;
- Order of the Ministry of Health of the Russian Federation of 01.04.2016 N 199n “On approving the rules of Good Laboratory Practice”;
- The federal law of the Russian Federation on circulation of drugs (Art. 4, 11) of April 12, 2010, No. 61-FZ;
- Manual for conducting preclinical studies of drugs. Under the editorship of Mironov A.N., Bunatyan N.D. et al., M., publishing house “Grif and K”, 2012;
- Directive 2010/63/EU of the European parliament and the European Union Council of September 22, 2010 on the protection of animals used for scientific purposes;
- Guide for the care and use of laboratory animals. National Academy press. – Washington, D.C. 1996;
- Current Protocols in Pharmacology (2005) Animal Models of Disease // Contributed by Petter Hedlund, Kenshi Matsumoto, and Karl-Erik Andersson;
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH);
- OECD protocols on testing of drugs in toxicological studies;
- ISO 10993 series “Medical Products. Assessment of biological effect of medical products”.