facilitate the myriad tasks confronting a drug delivery development scientist (Singh

et al. 2015; Beg et al. 2018; Singh et al. 2018a). Figure 18.10 enlists the select

computer software commercially available for carrying out QbD studies in labora-

tory or industrial milieu.

18.7

A Holistic Retroactive Account So Far

A clairvoyant glance of over 4600 research publications reported in updated litera-

ture on FbD-enabled development of drug nanocarriers indicates an accelerated

surge on the appliance of FbD paradigms, predominantly in the last couple of

decades. Figure 18.11, in this perspective, chronologically portrays an authoritative

testament

to

the

escalating

recognition

of

FbD

for

developing

diverse

nanoformulations systematically.

An extensive diversity of such nanostructured systems has been rationally devel-

oped, employing all-embracing designs and models. The pie chart in Fig. 18.12

illustratively portrays the current trends in nanomedicines.

Colossal merits have been observed while optimizing the product/process quality

of such nanomedicines because of their multifaceted intricate design, vibrant mate-

rial traits and stringent regulatory compliance requirements for numerous CQAs

(Kumar et al. 2014; Aksu et al. 2015; Beg et al. 2017a). On the whole, the FbD

studies consisting of >6 variables perpetually encompassed factor screening exer-

cise for prioritizing “few” variables among “possible so many” ones for subsequent

factor optimization. Albeit the input variables have been customarily ranging

between 5 and 7 in number, yet there have been some sporadic studies with >10

Fig. 18.10 Popular computer software employed during application of variegated QbD principles

18

QbD-Steered Systematic Development of Drug Delivery Nanoconstructs:. . .

335