Design process has one of the most important factors that contributing in pharmaceutical product quality. The pharmaceutical industry is has used the modern concept of Quality by Design (QbD) to apply science based manufacturing principles for new and existing products to assure quality of the formulation and to increase efficiencies, provide regulatory relief and flexibility, and offer importa...

In this paper, we present a pharmaceutical supply chain network model with outsourcing under price and quality competition, in both equilibrium and dynamic versions. We consider a pharmaceutical firm that is engaged in determining the optimal pharmaceutical flows associated with its supply chain network activities in the form of manufacturing and distribution. In addition to multimarket demand ...

It isessential to understand excipients’ critical material attributes. A QbDstrategy that includes historical data analysis and experimental work has beenused in functional excipients such as Hypromellose (HPMC) develop thisunderstanding. The use of multivariate helped identify excipientvariability the support it could provide improve final product robustness.

Designing a global pricing strategy for a new pharmaceutical product has become increasingly difficult as geographic reference pricing and parallel trade have introduced global price interdependencies between different nations. What may have been an optimal pricing strategy in a single country may no longer be optimal when considering the international ramifications of this price. The prices se...

There is no approved comparator list in Mongolia. The innovator pharmaceutical product is usually the most logical comparator product for a multisource pharmaceutical product because its quality, safety and efficacy should have been well assessed and documented in premarketing studies and postmarketing monitoring schemes. There are registered 65 products in Mongolia, containing Paracetamol, and...