Strategic Assessment of Prospects for Development of a New Combined Anti-Tuberculosis Drug Isoniazid + Pyridoxine: SWOT and PESTEL Analysis

The relevance of the study is due to the need to find strategic approaches to the development of new combined drugs for the treatment of tuberculosis in the context of increased requirements for the effectiveness of pharmacotherapy, safety, patient adherence to treatment and stability of drug supply. The development of a fixed combination of isoniazid and pyridoxine is a promising direction, but its practical implementation requires a comprehensive assessment of external and internal factors, potential benefits, limitations, and risks. The purpose of the study was to identify strategic prospects and main barriers to the development of a new combined anti-tuberculosis drug based on isoniazid and pyridoxine. PESTEL analysis was used to systematize political, economic, social, technological, environmental, and legal factors, as well as SWOT analysis to identify potential strengths and weaknesses of the project, opportunities, and threats. Based on the results of the study, the key external factors that may affect the implementation of the project are systematized, the potential advantages of the fixed combination and the main limitations related to the justification of the dose ratio, pharmaceutical compatibility of components, dosage form stability, and regulatory requirements are identified. Based on the integrated SWOT matrix, strategic directions for the further development of the project are formed, pharmaceutical development, quality and clinical feasibility confirmation, assessment of production capabilities and planning of potential implementation. The practical significance of the work lies in the formation of an analytical basis for making informed decisions on further research and development of a combined medicinal product. The conclusions are of a preliminary strategic nature and do not confirm the clinical efficacy or readiness of the drug for implementation.