the accuracy and immensity of the input data, as well as on the befitting selection of

designs and models. The phenomenal merits of FbD aside, it cannot be considered as

a panacea for all the issues pertaining to product development. Hence, appliance of

FbD needs to be coupled with the experiential prudence of an efficient scientist.

The practice of efficient enactment of QbD principles for developing novel and

nanostructured drug delivery technologies has certainly spiced up in the last few

decades, yet much needs to be done to make it a routine practice. As variability tends

to be omnipresent during the entire drug delivery product development life cycle,

application of QbD principles needs to be implemented at each and every stage.

Accordingly, a battery of endeavours needs to be undertaken to inculcate consistent

use of diverse systematic approaches in the holistic domain. With the widely

growing popularity and acceptance of the QbD paradigms, nowadays, these are

also required to be implemented for generic nanopharmaceuticals (or nanosimilars),

biopharmaceuticals (or biosimilars) and/or newer innovative brand products, analyt-

ical development, development of pure drug substances and even beyond, in order to

meet the unmet needs of patients. QbD is rationally prophesized to be a quality-

stimulator boon to speed up the pharma development issues, expending insignificant

resources for attaining the most significant performance.

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