In this chapter we discuss the development of products for biomedical applications from the point of view of analysis of their economic viability. The steps commonly involved in the development of biomedical products are covered, starting with the conception and development of the product itself, followed by preclinical and clinical testing, the production plant design and, ending at the stage of marketing the product. The costs usually associated with each step and the classical ways of estimating the initial investment required for the installation and startup of a new manufacturing plant and its production are discussed. Strategies for analyzing the investment profitability are discussed, such as the period of return on investment, the net present value calculation, and the internal/simple rates of return. As a case study, we present in detail the procedure to estimate the cost for the installation and operation of a plant for the production of particles of the biodegradable polymer poly(L‑‑ lactic acid) incorporating the bioactive agent 17 alpha‑‑methyltestosterone, a synthetic androgen compound that may be used as an alternative to testosterone. Profitability analysis of the resulting investment is also presented. Particles would be produced by the use of CO2 in supercritical conditions, in the SAS (supercritical fluid as an anti‑‑solvent) modality and would be useful, for example, in hormone replacement therapies, as a functional androgen and as an steroidal inhibitor of endogenous estrogen production, in addition to in the prevention and treatment of hormone‑‑sensitive tumors.
Authors
Bueno, Cecilia Z.
Veiga, Itiara G.
Oliveira, Fábio L.
Rosa, Paulo de Tarso Vieira e
Moraes, Ângela M.
Keywords
Análise de viabilidade técnico‑‑econômica,
Projeto de processos,
Custos,
Investimento inicial,
Custo de produção,
Analysis of technical and economic feasibility,
Process design,
Costs,
Initial investment,
Cost of production
