Abstract
Generic products are the chemical, pharmaceutical, and biological equivalents of the innovator product that is already registered and currently in use in one or more countries. During development, generic products are subjected to a battery of stability tests to guide the choice of excipients, packaging material and processing conditions, and help establish shelf-life, storage conditions, hold time, and transportation environmental control. This chapter discusses key aspects of stability testing through the life cycle of a generic product.
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Bajaj, S., Rajamani, S., Gogia, M. (2018). Stability Considerations in the Life Cycle of Generic Products. 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_9
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DOI: https://doi.org/10.1007/978-1-4939-7686-7_9
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