Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
[Feature articles] “Societal Issues and DDS” Editor:Mitsunobu R. Kano
Clinical Development & Commercialization of DDS to meet Unmet Medical Needs
Toshio Nagae
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2022 Volume 37 Issue 1 Pages 63-70

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Abstract
DDS would provide massive clinical and economic advantages over existing active pharmaceutical ingredients(API). The advantages reflect concerted strategies of clinical development and commercialization including Reimbursement pricing. We design Target Product Profile(TPP) such two different ways of thinking as Seeds and Unmet Medical Needs. And we develop the strategies to optimize Value of Product-X reflecting R&D-Commercial(C)-Interaction. The interaction is essential for the value optimization by achieving happiness for Patients, Physicians, Para-medicals, Policy-makers, Payers, and Pharma companies namely P X 6. This paper shows concept of Quantitative Forecasting Model including number of patients in specific indication for Product-X, Reimbursement price, Cost of goods, R&D costs and Operating profit.
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© 2022 The Japan Society of Drug Delivery System
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