Certara software

Biological medicines (“biologics” or “large molecule drugs”) now account for 30% of new drug approvals and up to 50% of the pharmaceutical industry’s pipeline. Biologics differ from small molecules because they are much larger, have slower absorption rates, confined distribution, and different elimination. They are designed for a specific target, typically found on the cell membrane, which they bind to with high affinity. Due to this high affinity, the binding to the target and subsequent turnover of the drug–target complex can contribute significantly to the disposition of biologics. The pharmacokinetic (PK) properties of biologics are quite distinct from that of small molecules, as are the interactions with targets (pharmacodynamics).

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform for determining first-in-human dosing, optimizing clinical study design, evaluating new drug formulations, setting the dose in untested populations, performing virtual bioequivalence analyses, and predicting drug-drug interactions (DDIs). Simcyp is being applied to small molecules, biologics, ADCs, generics, and new modality drugs.