Assessment of Large Versus Small Molecules in CV SP

SP assessment of BPs is based on ICH M3(R2), S6(R1), S7A, and S7B guidelines. With regard to BPs, the M3(R2) guideline addresses only the timing of nonchnical studies relative to clinical developmenf and defers to S6 guideline 

Drug candidate SMs are profiled for secondary pharmacology activity to identify potential off-target effects and side effect liabilities (Bowes et al., 2012 Papoian et al., 2015) however, BPs are not are not routinely profiled in the 

TABLE 9.1 Some Characteristics of Small Molecules and Biopharmaceuticals 

Modality Synthetic chemicals mAb, peptides, peptibodies, fusion proteins, ADC, BiTEs , and vaccines 

Typical species of choice Rodent and nonrodent (dog, NHP, minipig) NHP 

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