Abstract
A primary objective in the analysis of safety data is to establish a comprehensive safety profile of a drug. This is a key consideration and an area of focus in both the pre-marketing drug development and post-approval life cycle management phases. In the pre-market setting, the primary safety information comes from clinical trials data covering several domains and other supporting information, such as, safety pharmacology, toxicology, historical control data, and the literature on the therapeutic area and drug class.
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Munsaka, M.S. (2018). A Question-Based Approach to the Analysis of Safety Data. In: Peace, K., Chen, DG., Menon, S. (eds) Biopharmaceutical Applied Statistics Symposium . ICSA Book Series in Statistics. Springer, Singapore. https://doi.org/10.1007/978-981-10-7826-2_11
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