The Assessment of The Quality, Efficacy and Safety of The Investigational Medicinal Product in The Absence of An Approved Registration Dossier

Today the pharmaceutical industry is one of the highly regulated fields with many rules and regulations which are quite volatile and are updated at least every decade [1-8]. Practical guidelines and recommendations are published by regulatory authorities and manufacturers even more often. As a result, things that were state-of-the art yesterday may not be appropriate tomorrow, especially in the rapidly changing area of biopharmaceutical development.