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- W2745697792 endingPage "385" @default.
- W2745697792 startingPage "341" @default.
- W2745697792 abstract "This chapter discusses the differences between the “traditional” small-molecular-weight compounds and these “novel” large-molecular-weight compounds and the impact of these differences on nonclinical safety assessment strategy. Small-molecular-weight compounds can cause toxicity due to on-target effects (i.e., exaggerated pharmacology), off-target toxicity, and toxicity due to reactive metabolites. Metabolites can be biologically inactive or active or can exhibit greater or reduced toxicity. Successful nonclinical safety evaluation of biologics begins with an understanding of the fundamental differences in the type of toxicity exhibited by biologics, that is, exaggerated pharmacology and nonspecific immunological reactions, for example, immunogenicity. The guidelines in which biologics are mentioned briefly and could potentially serve as specific functional advice include ICHS 7A (Safety Pharmacology), ICH S5(R1) (Reproductive toxicity information), ICH S1A (need for carcinogenicity studies as stated in ICH S6(R1)), and ICH S3A (toxicokinetics (TK))." @default.
- W2745697792 created "2017-08-31" @default.
- W2745697792 creator A5015954706 @default.
- W2745697792 creator A5046524736 @default.
- W2745697792 creator A5077876000 @default.
- W2745697792 date "2017-08-14" @default.
- W2745697792 modified "2023-10-17" @default.
- W2745697792 title "Safety Considerations for Biologics" @default.
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