Below are steps involve in investigational new drug application:
- Research: definition and characteristics
Historically, the discovery of many medications has been casual. Without knowing the origin of most diseases, people have always had traditional remedies, most natural products that, by the method of trial and error, managed to remedy a disease or evil.
Today things have changed and both the discovery of new drugs and their development have become a long and complex process.
Research, which begins when something is not understood, involves reflection and requires the collection and analysis of data to arrive at decisions based on true evidence. Strictly speaking, research is a systematic and refined technique of thinking that uses special tools, instruments and procedures to obtain the most appropriate solution to a problem.
In general, the research has the following characteristics:
- Stick to a problem.
- It is an original work.
- It is based on a mental activity of curiosity.
- It requires an open or critical spirit.
- It is based on the assumption that everything is subject to laws and generalizations.
- It is a cause-effect study.
- It is based on quantifiable measures.
- It implies a conscious technique.
When it comes to the investigation of a drug, the development process is long and expensive since it has to demonstrate, throughout its different phases that the new drug meets the requirements of efficacy, safety and quality demanded for its commercialization and administration in people.
This process includes numerous activities and disciplines, all aimed at demonstrating, in addition, an optimal cost-effective relationship, which implies a great intellectual effort and an enormous drug safety surveillance factors.
From their discovery and until they become medicines, the initial substances with which the investigation begins receive different names, depending on the stage of the development process in which they are found.
- Conditions necessary to conduct an investigation
In order to carry out research work the following elements are necessary:
-Personal: all research requires qualified personnel according to the study that is intended to be carried out. The researcher must gather a series of qualities. The most important is specialized knowledge in the area to investigate. You must also have patience, willingness, thoroughness and fixedness, as well as feel stimulated during the development of the research, a feeling that generally arises from the relationship with other researchers and teamwork.
-Infrastructure: adequate material and facilities to carry out the investigation. Their number and characteristics will depend on the type of research to be done.
Any research work requires knowledge and study of the publications that have been made so far on the subject.
-Economic means: to carry out a quality investigation it is necessary to have sources of financing that support the development of the project. Historically, the origin of this financing has been in the pharmaceutical industry, in state-dependent agencies such as the Higher Council for Scientific Research (CSIC) or Universities, in private foundations and in hospitals.
-Research environment: it is convenient that the place where the research is carried out has, in addition to the necessary structure, a work environment that allows keeping motivated the professional who conducts the research, increasing its efficiency and productivity.
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