Abstract
Stability of drug substances and their products is required to be ensured throughout their retest period/shelf-life. Various guidelines explaining the concept, procedures, and protocols have been developed and issued by international, regional, and national regulatory agencies to help the manufacturers in the generation of valid and acceptable stability data. This chapter enlists and briefly discusses the available stability guidelines, and also outlines the trends of emerging requirements.
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Singh, D.K., Singh, S., Bajaj, S. (2018). Regulatory Guidelines on Stability Testing and Trending of Requirements. In: Bajaj, S., Singh, S. (eds) Methods for Stability Testing of Pharmaceuticals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-7686-7_1
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