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Balancing the Needs of Patients, Regulators, and Industry to Satisfy the Global Demand for Inhaled Products

Howlett DJ.

RDD Asia 2018. Volume , 2018: 119-128.

Abstract:

Metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are complex dosage forms; however, their complexity alone does not define the cost and hence the price of these inhalation products. Understanding how investment and commercial strategy can impact both the cost of the product, as well as the potential price that may be viable (and for how long) is important. Factors including impact of material cost fluctuations, regulatory expectations, increasing overhead costs, and the implications of investment decisions must be considered to understand the true cost of a product. Decisions made in the early and mid-stages of a development program can have a significant impact on the cost and hence price and affordability of a product, which ultimately translates in to the long term viability of the product.