Statistical processing (BE, I, II, III phases)

Bioequivalence is a key aspect in the development of generic drugs. To confirm it, a comparative study of the pharmacokinetics of the drug under study and the reference (original) drug is conducted. Statistical analysis plays a decisive role in this process.

The main method for assessing bioequivalence is the calculation of the confidence interval for the ratio of the geometric means of critical pharmacokinetic parameters. Recently, adaptive study design has been increasingly used, which allows adjusting the sample size and other study parameters during its implementation based on intermediate results.

This allows optimizing the sample size and increasing the likelihood of successful proof of bioequivalence. Also, for drugs with high variability, the bioequivalence method with boundary expansion can be used.

Early-phase studies are aimed at studying the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of new drugs. Statistical processing of data at these stages is important for making decisions on further development of the drug.

The analysis includes the assessment of key pharmacokinetic parameters such as AUC, Cmax, Tmax, T1/2 (half-life), clearance, volume of distribution, and their dependence on the dose, route of administration, and individual patient characteristics. Statistical methods are used to determine the optimal dosing regimen and assess the relationship between pharmacokinetics and pharmacodynamics, as well as for a preliminary assessment of the drug's effectiveness. The results of statistical analysis allow making informed decisions on the further development of the drug, optimizing the design of clinical trials, and increasing the likelihood of success in subsequent phases of development.

Specialized validated software packages are used to conduct statistical analysis, which ensure the reliability of the results.