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- W2804659060 abstract "Forced degradation or stress testing on proto-formulation is considered as the most predictive approach towards long-term stability studies. The aim of applying stress is to identify the weaknesses of the chosen formulation identified by the use of suitable analytical test methods. Based on the experience gained from forced degradation (stress) stability studies, no new and unknown impurities should be detected during ICH (primary) stability studies at later development stages. For the primary stability testing design, matrixing and bracketing approaches can be used for testing of new drug products, if sufficiently justified. Knowing that bracketing is usually accepted by the different authorities, the design and strategy for matrixing should be discussed in advance before starting these stability studies." @default.
- W2804659060 created "2018-06-01" @default.
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- W2804659060 date "2018-01-01" @default.
- W2804659060 modified "2023-09-23" @default.
- W2804659060 title "Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach" @default.
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- W2804659060 doi "https://doi.org/10.1007/978-1-4939-7686-7_4" @default.
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