新药研发临床前安全性评价讲述.pptVIP

* * This slide highlights the differences between biopharmaceuticals and small molecule pharmaceuticals. For instance, the majority of biopharmaceutical toxicity is due to species-specific exaggerated pharmacology. In contrast, small molecules and their metabolites can cause nonpharmacological toxicity and the pharmacology of small molecules is frequently not species specific. In addition, biopharmaceuticals are very large with complex secondary and tertiary structure compared to small molecules. Because the FDA plans to consolidate most divisions of the Center for Biologics Evaluation an