Abstract
Safety evaluation is a continuous part of the evolutionary cycle for all pharmaceutical products. Information collected to assess safety is determined, in part, by laws that describe the data needed for regulatory compliance. Other data are collected for product stewardship and address the need to protect health during manufacturing, as well as use and disposal of the product and byproducts from manufacturing. Product stewardship requires detailed information on the composition of the product, precursors, manufacturing byproducts, as well as disposal and degradation products. This in turn requires knowledge of the manufacturing processes and nature and use of the product.
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Schwetz, B.A., Mattison, D.R. (1996). Decision Strategies in Assessment of Reproductive and Developmental Toxicology: A Paradigm for Safety Evaluation. In: Alexander, N.J., Wentz, A.C. (eds) Idea to Product. Serono Symposia USA. Springer, New York, NY. https://doi.org/10.1007/978-1-4612-0743-6_19
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DOI: https://doi.org/10.1007/978-1-4612-0743-6_19
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