Setting specifications for drug substances and drug products is a complex process. Many factors must be considered such as patient requirements, clinical and development experience, and global regulatory expectations. The specification setting process starts with...
CITATION STYLE
Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). Specifications (pp. 227–267). https://doi.org/10.1007/978-3-319-50186-4_7
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