Abstract

A REVIEW ON THE SCIENTIFIC AND REGULATORY CONSIDERATION IN SIGNIFICANCE OF THE DEVELOPMENT AND VALIDATION OF DRUG SUBSTANCES AND DRUG PRODUCTS: FORCED DEGRADATION AND STABILITY STUDIES

*Ajinkya Krushna Pande, Satish Y. Zambare and G. H. Nikam

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Abstract

The intricate scientific and regulatory considerations involved in the development and validation of drug substances and products include forced degradation and stability studies. These studies evaluate the deterioration of drugs under different stressful conditions to ensure their safety, effectiveness, and quality. It is important that the selection of stress conditions, analytical methods, and statistical analysis are reflective of real-world exposure and validated for accuracy. Regulatory bodies like the US FDA and European Medicines Agency require stability testing for approval. Forced degradation and stability studies are crucial in ensuring the safety, effectiveness, and quality of Drugs.

Keywords: Oxidation, photolytic degradation, thermal, degradation, Potency, Degradants, accelerated conditions, Stress testing, purity.