ABSTRACT
The prime objective of any pharmaceutical product design and development is to generate an assurance that the therapeutic active in the proposed formulation or dosage form is suitable, safe and effective for intended use and holds acceptable quality. The pharmaceutical industry, since its emergence, is expected to work with this vision while converting the market opportunity into commercial reality. Since it deals with human life, safety and health, regulations covering it are very stringent as they rightfully should be. In view of this, pharmaceutical product development is a very time-consuming and resource-intensive process. It is estimated that the cost of developing a new drug is higher than 1.2 billion USD and some estimates put it as high as 2.6 billion USD (PhMRA 2015; Tufts CSDD 2014) and it takes anywhere between 10 and 15 years to do so (PhMRA 2015).
