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PLContext
A formulation specialist in a pharmaceutical company is developing a generic medicinal product and must demonstrate that its dissolution profile is comparable to that of the reference listed drug (RLD). According to EMA and FDA bioequivalence guidelines, similarity of dissolution profiles is a key requirement for the approval of a generic product. The specialist must therefore perform a dissolution profile comparison using validated statistical methods and prepare a report for regulatory submission. The stakes are high — incorrect statistical analysis may result in requests for additional data or even rejection of the application.
Purpose
The purpose of using the StatSoft DPC application is to enable fast and reliable assessment of the similarity between the dissolution profiles of the test (generic) product and the reference (innovator) product, using validated and regulatory-compliant statistical methods.
Application
The formulation specialist begins by creating a new project in StatSoft DPC, importing dissolution data for both the test (generic) and reference (RLD) batches from various sources: Excel files, Statistica worksheets, or—most efficiently—from the dedicated StatSoft DPC-DB database.
Next, the specialist selects the appropriate comparison method based on regulatory guidelines and the characteristics of the data. This may include model-independent analyses (difference factor f1, similarity factor f2), multivariate statistical distances (T2EQ, ACLMD), bootstrap approaches (e.g., bootstrap f2), or model-dependent analyses using theoretical dissolution curves.
StatSoft DPC automatically performs all required calculations, generating a complete set of results, including raw data, detailed statistical analyses, comparative dissolution plots, and clear pass/fail outcomes with respect to regulatory acceptance criteria. Once the report is generated, the formulation specialist reviews it, adds product-specific interpretations or contextual information, and finalizes the documentation for inclusion in the regulatory submission package.
Outcome
Using StatSoft DPC, the formulation specialist successfully demonstrated that the dissolution profile of the generic product matches that of the reference product, applying the bootstrap f2 method—recommended by the EMA in cases of high variability observed at early time points.
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Benefits:
Time Efficiency: Statistical reports for dissolution profiles comparison prepared in minutes instead of hours.
Regulatory Compliance: Comprehensive, audit-ready documentation with lower risk of regulatory observations related to inadequate statistical analysis.
Data-Driven Decisions: Evidence-based recommendations supported by robust statistical analysis.
Consistency: Standardized reporting format, pre-validated statistical methods and report templates.
Strategic value: Reduced regulatory submission risk through validated, defensible statistical analysis.