QbD-steered product or process understanding, and usage of DoE and QRM

principles, but acquiring deeper knowledge and know-how of product development

paradigms too.

The exceptional feature of an archetypal FbD strategy is its precise portrayal or

premonition of drug product performance and its distinct ability for detection and

estimation of possible synergism or antagonism among several input variables

(Singh et al. 2011c; Singh 2013; Beg et al. 2017a). Abundant shortcomings of the

OFAT approach, discussed in the previous section, verily call for adoption of FbD as

a much more sensible, systematic and innovative approach to engineer drug

nanocarriers for catering to the specialized and customized needs of patients

(Singh et al. 2011c; Beg et al. 2017a). While embarking upon the optimized

nanostructured drug delivery technologies, FbD offers myriad advantages over the

traditional OFAT approach (Singh et al. 2009a, b, 2011c, 2012), as outlined in

Box 18.1.

Box 18.1 Key Benefits of Implementing QbD Practices During

the Development of Drug Delivery Products

Meritorious visages of QbD-steered drug delivery development

• Superior quality drug delivery products

• Augmented product and process comprehension

• Perceptive planning employing synergistic team approach

• Decreased outflow of manpower, materials, money and time

• Improved access to the commercialization

• Reduced drug product rejects and recalls

• Quicker regulatory review and approval of products

• Admirable returns on corporate investments

• Negligible consumer cynicism on generic drug products

• Reduced regulatory queries and requirements

• Reduced post-approval changes

• Wider operating ranges

18.4

FbD Methodology

The entire FbD methodology can be holistically envisioned to be implemented in

five steps, as illustrated in Fig. 18.3.

18.4.1 Step I: Postulation of Objective(s) of Developing

Nanostructured Drug Products

A quality target product profile (QTPP) delineating various desired quality traits

considers its efficacy and safety for the end user, i.e. the patient is outlined. Selection

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