The production of the material needs to be scaled up and the NCE refined or purified. Methods for quantifying the material need to be developed. Pharmacological studies pass beyond initial screening for activity to looking for side effects. Toxicology starts to look for acute dose problems, then progresses to sub acute problems. Methods for quantifying metabolised products need to be developed.
Regulatory dossiers can start to be compiled.
Formulation begins Formulation Back to the top Even at the 'proof of principle' stage, the formulation can play a significant role. A soluble, stable NCE is relatively rare, such that obtaining an effective concentration in an organ bath may be impossible without for example, including a surfactant. In the in vivo testing, a NCE is often given by gavage, inhaled as an aerosol or simply mixed with the feed. In oral dosing, if the NCE is rapidly hydrolysed in the stomach, then, for any 10mg dose, less than 1mg may be delivered. If delivery is by the inhaled route, a minor variation in particle size may mean that the majority of the dose ends up in the stomach rather than the lungs.