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ISSN 1996-3521 (Electronic)

2014, Number 18

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INFODIR 2014; 10 (18)

Considerations about the clinical development strategy of a pharmaceutical product

Marrero MMA, López SP, García MAJ, Alonso CL, López PP, Tirado MM

Language: Spanish
References: 18
Page: 41-53
PDF size: 296.94 Kb.


ABSTRACT

Introduction: The development of a new drug is a long and complex process which requires a lot of resources. Objective: To carry out a strategy proposal for the industrial clinical development for drugs trading purposes. Method: It is a descriptive two stages structured investigation. The first stage consisted on the revision of the research methodology, clinical trials and pharmacoepidemiology, strategies, regulations and drug trading. The PUBMED and Google were revised using different descriptors. Websites of drug producing centers were also analyzed. After a careful reading of every search, documents selection according to the quality of authors and publishing sites was performed. Interviews to three experts on the topic were made which qualitatively allowed to arrive to the results shown. Those considered as experts have more than ten years of work in the investigation and development of pharmaceutical products. Results: A strategy for the development of pharmaceutical products that includes five steps was proposed: World Status of a disease or health problem, Tendency of the disease in the future; Current state of the pharmaceutical market for that disease; Feasibility to be carried out inside the producing center and executive decision. Conclusions: La propuesta realizada para el desarrollo clínico de un medicamento, constituye una guía o patrón de referencia para la investigación en este campo y estandariza el proceso metodológico para la ejecución de investigaciones de este tipo. The proposal carried out for the clinical development of a drug is a guide and a reference pattern for the research in this field and standardizes the methodological process for the development of investigations of this type.


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