**2. Basic elements of quality by design**

## **2.1 Set the standard profile for the target smart dosage form**

A target standard profile for smart dosage form describes how a smart dosage form will be utilized by the end-user. A systematically developed standard profile can ensure the arrangement of objectives across departments of the company, advance development of timelines, reduction of risks, and finally lead to an optimal smart dosage form. A targeted standard product profile is very important for smart drug delivery development due to the variety of administrations and the variety of possible end-user (patients, nurses, physicians, and pharmacists) [12].

## **2.2 Recognition of the critical quality attributes (CQAs)**

The next step in QbD for smart dosage form development is recognition of the critical quality attributes (CQAs). CQAs are physical, chemical, biological, or microbiological characteristics or properties of the pharmaceutical smart drug delivery system (in-process or finished) that must be within specified standards to ensure quality. CQAs may include identification, content, assay, uniformity, solvents, degradation, products, dissolution or drug release, moisture content, moisture uptake, microbial limits, and other properties such as color, size, shape, etc. [9, 13].

*Applications of Statistical Tools for Optimization and Development of Smart Drug Delivery… DOI: http://dx.doi.org/10.5772/intechopen.99632*
