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- W59013309 abstract "Abstracts The regulatory strategy for the nonclinical development of biopharmaceuticals is based upon a case-by-case approach incorporating a solid scientific foundation, modality-specific considerations, and an understanding of current worldwide health authority guidelines. The primary regulatory reference for the nonclinical development of biotechnology-derived pharmaceuticals is the International Conference for Harmonisation (ICH) S6(R1) guideline. This chapter focuses on the recommendations found in the ICH S6(R1) guideline and how they may be implemented to fulfill the expectations of health authorities worldwide. Many key aspects of the nonclinical program are covered, including species selection, considerations for repeat-dose toxicity studies, immunogenicity testing, developmental and reproductive toxicity, genotoxicity and carcinogenicity studies, and special considerations for anticancer biopharmaceuticals." @default.
- W59013309 created "2016-06-24" @default.
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- W59013309 date "2013-01-01" @default.
- W59013309 modified "2023-09-26" @default.
- W59013309 title "Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines" @default.
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- W59013309 doi "https://doi.org/10.1016/b978-0-12-394810-6.00002-2" @default.
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