When a patient comes to the office, it is usually because he has a disease or pain, which requires an assessment before being able to issue a correct diagnosis to finally grant a prescription with the medications and indications to follow in order to recover completely. Previously there was only the patent medicine; however, in recent years generics have emerged, which claim to have the same clinical efficacy but with a significantly lower price, is it really true?
Talking about generic drugs is not a simple issue, as it continues to be controversial even within the medical community itself, as there are opinions of all kinds and while some claim that there are no notable differences between the use of an original and a generic drug, others believe that there are significant changes and some others affirm that in the end, they are not as economical as they are announced, taking into account the possible adverse effects and the lack of efficacy, so it is pertinent first to know the way in which a study of bioequivalence in our country.
The importance of bioanalytical services has been widely emphasized both by the authorities and regulatory as per the pharmaceutical industry.
Technical reasons: it is known that biological processes that account for the availability of a drug in the body (absorption, conjugation, elimination) are related to the genetics of individuals and this with their ethnicity. A classic example of this is that some medications do not have the same efficacy in the population. Consequently, the more similar is the population in which the bioequivalence study is carried out with which they will then use the evaluated drugs, the better.
The validity of bioanalytical services depends, among other things, on whether the tested drug comes from the same production line as the one made available to patients. Also, that its storage and distribution conditions are equivalent to those commonly used for marketing. Thus, conducting studies abroad may involve some biases if all the variables of transfer and storage of medications are not controlled very strictly. On the other hand, the audit and joint work processes are simplified.
Bioanalytical services involves different actors: doctors, nurses, nursing technicians and health service personnel (hospital or clinic) who are responsible for administering the drug, sampling biological fluids and care and Comfort of the volunteers. Also pharmaceutical chemists, medical technologists, and biochemists involved in the processing and analysis of the samples. Of course, statisticians, who process the data and determine the significance of the observed variations. Finally, the professionals of the regulatory agencies and administrators of the companies involved.
Participation in a bioequivalence study implies a particular training by the professionals who participate in it. It also requires volunteers to understand all aspects of it. In addition, it opens space in the mass media. Therefore, as more bioequivalence studies are conducted in our country, more people will learn about and about them. In summary, only good reasons exist for continuing to get bioanalytical services in the country, is where health professionals and services are well prepared and willing.