Procedure for Applying Predictive Analysis in the Development of Generic Drugs

The Pharmaceutical Industry faces the challenge of reducing the development time of new products, especially generic drugs. Predictive analytics is a category of analyzing historical data to make predictions about future outcomes based on statistical and machine learning techniques. The objective of this work is to design a procedure to incorporate predictive analysis in decision making during the development of generic medicines supported by scientific and economic arguments. The study was divided into two phases. Phase 1 will characterize the development value chain of generic medicines using the weighted SWOT Matrix to determine its status and the Delphi method to evaluate agreement between experts. Phase 2 detailed analysis of the techniques and tools to be used in the design of the procedure. The SWOT matrix showed that the chain has weaknesses in that the culture and knowledge of this work tool is not developed, but its strength is that it has a culture of good practices and quality management, as well as an adequate infrastructure. to make effective use of information technology. The procedure has 5 stages where the actions, resources, risk analysis and indicators to evaluate the impact are collected. The designed procedure contributes to streamlining decisions, improving quality, reducing costs and accelerating time to market, offering a significant competitive advantage.