Conclusion

This study outlines the various stages involved in the discovery and development of a new active ingredient. Subsequently, and with a view to submitting a marketing authorization application for a drug (MA), the corresponding pharmaco-toxicological, clinical and pharmaceutical files must be supplied.

The pharmaceutical dossier includes a description of the preparation method, requiring the use of various industrial processes ranging from extraction to hemisynthesis or total synthesis. The choice of method generally depends on its cost price.

On the other hand, as long as the conformity of an active ingredient with the standards set by the pharmacopoeia or by the manufacturer has not been established, the active ingredient is not retained for pharmaceutical formulation, hence the importance of drug testing.

First,...