Pharmacokinetics assessment of drugs and substances

  1. Comparative study of pharmacokinetics

According to the Manual for conducting preclinical studies of drugs (Part one. M.: publishing house “Grif and K”, 2012, P. 854), comparative study of pharmacokinetics means the research of the drug in a single dose using one animal species accompanied by an analysis of one type of biomaterial – blood plasma or serum. This study includes:

  • a design of the quantitative determination method of an active substance in bioliquid (plasma or serum), pilot experiment to determine the dose for administration;
  • a study of pharmacokinetics of a single dose administration, animals used are rabbits, rats or mice, blood sampling is not less than 10 time points;
  • an analysis of data obtained;
  • a calculation of pharmacokinetic parameters by the model-independent method of statistical moments, writing the report based on the experimental data and in accordance with GOST 7.32-2001 “Report on research work”

Study on pharmacokinetics of the original drug

The study is carried out according to the Manual for conducting preclinical studies of drugs (Part one. M.: publishing house “Grif and K”, 2012, P. 845—855). The study includes the following scope of work:

  • design and validation of the quantitative determination method of an active substance in blood plasma (the main type of biomaterial);
  • pilot experiment aimed at clarifying the drug doses for further analysis of pharmacokinetics;
  • adaptation and revalidation of the quantitative determination method of an active ingredient in other types of biological material;
  • assessment of linearity of drug pharmacokinetics provided a single dose administration using three dose levels. Distribution of active substance in the tissues (brain, liver, kidneys, spleen, skeletal muscles, heart) is studied in parallel;
  • study of the drug elimination provided a single dose administration (analysis of one type of excreta – urine);
  • repeated administration of the drug at a single dose (in case of an approved linearity of pharmacokinetics) or using two levels of doses (it is necessary, if pharmacokinetics is nonlinear). Analysis of one type of biological material – blood plasma;
  • study of pharmacokinetics and relative/absolute bioavailability of test chemical provided a single dose administration;
  • calculation of pharmacokinetic parameters by a model-independent method of statistical moments, assessment of pharmacokinetics linearity, writing a report based on experimental data and in accordance with GOST 7.32-2001 “Report on research work”

To perform the work we have qualified and trained experts and the appropriate equipment for quantitative determination of drugs and their metabolites in vivo and in vitro using HPLC, IFA, HPTLC, capillary electrophoresis methods.

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Фармакокинетика