Preclinical Research
Scientific studies conducted before human testing, including laboratory experiments (in vitro), animal studies (in vivo), and computational modelling. Preclinical data provide the safety evidence required to begin clinical trials. Many research compounds have only preclinical evidence, which is a fundamentally lower evidence level than human trial data.
Technical Context
The preclinical programme for a peptide drug typically includes: in vitro receptor binding and functional assays (determining potency, selectivity, and mechanism), cell-based assays (confirming biological activity), ADME studies (stability in plasma, microsomal stability, permeability), pharmacology studies in relevant animal models (dose-response, time course, comparison to standard of care), safety pharmacology (cardiovascular/hERG, respiratory, CNS safety), toxicology (acute, subacute, chronic toxicity in two species — typically rodent and non-rodent), genotoxicity (Ames test, chromosomal aberration, micronucleus), and reproductive toxicity (fertility, embryo-foetal development, peri/postnatal development). For peptide drugs targeting human-specific receptors, transgenic animals expressing the human receptor may be needed for relevant pharmacology studies.