The path from innovation of diagnostic products to marketing: Medical and economic release

Md. Shabbir Hasan

Many men many minds which is that the practicality. Pandemic coronavirus (COVID-! 9) is running everywhere the planet as an excellent epidemic. There's no remainder of scientists to create or discover the remedies and antidotes of this. There are some sorts of antidotes already discovered but not yet final. All kinds are under process of examination, justification, and for validation. But I hope to be finalized soon. Within the mean solar time, many debating are happening every antidote in favor of and disfavor of.

On the opposite hand, we expect only a few about the diagnostic product quality and its method. In fact, we all know also only a few about this and provides less importance thereon. But it'll never be forgotten that it's not smaller than the treatment of diseases. The standard of diagnostic products and therefore the method of diagnostic depends on the right diagnosis of diseases. If the diagnosis of diseases is wrong, the treatment of diseases is additionally wrong. That is, the right treatment of diseases depends upon the perfect diagnosis of diseases. For the COVID-19, there also are different types of diagnostic method which are being applied in several locations with different situations. Let's start to understand the knowledge of this which one is the best and excellent.



At present, thanks to the epidemic caused by the new coronavirus or Covid-19 around the world, normal life is extremely disrupted. The amount of infected people is increasing day by day and therefore the death procession is getting longer. Effective vaccines or antiviral drugs to deal with this catastrophe haven't yet been discovered. The sole thanks to prevent the spread of this complex virus is to detect it very quickly then isolate the patient from everyone else and supply treatment as required.



While the 'correct scientific method' of virus detection isn't unknown, developed countries like the US, the UK, Italy, France, and Spain have also faced difficult challenges thanks to lack of necessary preparations and adequate equipment and chemical reagents. They're ready to find how out of this crisis over time. But thanks to the shortage of testing kits, Bangladesh is slowly heading for a deep disaster. To date, the speed of virus detection in Bangladesh is merely 47 per one lakh population, which is negligible compared to developed countries. Within the wake of such a catastrophe, the announcement by Messrs. Public Health Pharmaceuticals Ltd. of the invention of a 'Rapid Testing Kit' to detect antibodies within the body of an individual infected with coronavirus locally within the country has given a glimmer of hope to the state.



It should be noted that currently, two methods are playing a key role in detecting the infection of this virus. One is that the reverse transcription-polymerase chain reaction (RT-PCR) and therefore the other is that the antibody or serological test. The PCR method confirms the presence of the virus by identifying the genetic material of the virus - RNA - with swabs from the patient's nostrils. This is often the worldwide ‘gold standard’ method. That's why the amount of cases of the virus-infected worldwide is essentially PCR dependent. On the opposite hand, the antibody test detects antibody proteins that are made within the body to cure the disease thanks to the virus attack by taking blood droplets from the patient's body.
Of deep concern is that the ongoing debate over the effectiveness and validity of the invention of the ‘Rapid Testing Kit’ for antibody detection. Like all other political issues, the state seems to be divided.

The nation's emotions are intimately involved in this issue. Because in such an unprecedented national crisis, if the country is often partially alleviated by applying its own invented technology, it'll be an excellent pleasure and really financially cost-effective for the state. Confidence is going to be created among the people of the country on their own talents and skills. The younger generation is going to be inspired to ascertain that within the future. So without getting involved in unnecessary debates and without getting caught up in emotions, if there's only science-based argument or constructive discussion, it's good for everybody.
Remember, diagnostic products, medicines, medical equipment, etc. aren't like other common products. These are regulated or regulated by law in each country. Marketing, transportation, stocking, and use - everything has got to follow specific rules and standards. This is often because the utilization of those products involves the life and death of the customer. It's the responsibility and duty of the state to closely monitor these steps and processes and to make sure that proper rules are followed.

Note that the coronavirus detection kit we are talking about here is an 'in vitro diagnostic' (IVD) product. To check it outside the body without applying it to the body. Such products are classified as medical devices in America and Europe. It's a 'law-regulated' product, like medicine, as its management and treatment methods depend upon its outcome. These are often low, medium, and top-quality risk products, counting on the regulation. An equivalent is going to be true for high-risk products, but not for low-risk products.


The steps that require to be taken in marketing from the invention of such a product are discussed below:
Innovation: Any innovation in science is born from a latent idea. If the thought isn't tested, it's not appropriate to say any invention or discovery. Through research and experimentation, the latent concept becomes fairly realistic in one step. Even seemingly beautiful ideas become worthless fantasies experimentally and abandoned. That's why science and research are filled with many successes also as endless failures. So sighing within the lifetime of scientists may be a common and everyday thing.

If the thought works properly after experimentation, then only innovation is often claimed. At now, if the thought proves to be true within the test, then the property is often applied for and published within the refereed journal with the acceptable information and data. For property, the innovation must possess the subsequent three qualities, viz., Novelty, commercial value, and non-conventional. This is often to form sure that it's not been published in any science journal before, which doesn't conflict with anyone else's patents or patents. Moreover, one of the foremost beautiful aspects of science is that if somebody else has invented an identical work before, it should be properly evaluated and recognized within the publication and in property. At this stage, the inventor can claim his invention or discovery. If one claims innovation without taking this step, then it's no value in science, and it's immoral.



Verification and usefulness verification: the most goal of research within the industry is to convert innovation into a product suitable for human consumption and to plug it by completing the proper process. That’s why innovation has got to be thoroughly checked and selected.



Otherwise, there's a risk of giant losses to consumers. Verification is that the verification of whether an invented product or process actually works properly and evaluates its usability. The users here are often ordinary people, technical people working within the diagnostic center, or doctors or nurses within the chamber. That's why the kinds of products invented are repeatedly and thoroughly tested by quite one person - very skilled, less skilled, even by inexperienced people. This step is added to simplify the tactic of use. Because everyday users might not be as qualified as inventors. At this point, the intended use of the merchandise is decided. Many patentable and journalistic inventions can also be abandoned at this stage thanks to uncertainties.



It is advisable to require this step through a totally different person, excluding the inventor, because the inventor could also be hooked into his own invention and should be biased. It’s during this step that the materials or raw materials wont to make the merchandise are reviewed. Because of the standard of raw materials and their supply chain isn't ensured, it'll not be reliable in any way. It's also seen whether the staple is manufactured in accordance with international standards. During this case, the standards of the world organization for Standardization (ISO) and therefore the current Good Manufacturing Practice (CGMP) are followed. It's equally important to check multiple raw materials, using raw materials from different sources/companies. Commercial products, especially pharmaceuticals and diagnostic products, can't be made using raw materials for research. If the staple and therefore the product is temperature-sensitive or perishable, then the life cycle of the merchandise from storage, transportation, packaging, durability, and production to the hands of the customer has got to be thoroughly examined.



If everything goes well, Protocol - Simple procedure (SOP) is written. This protocol has got to be followed repeatedly to check its effectiveness through multiple technicians. Such a practice is named Good Development Practice (GDP). After browsing of these steps, the protocol for creating the merchandise is finalized. It can not be changed, meaning the protocol is going to be locked at this stage. Only after locking the protocol can an application for authentication or validation be made to the Drug and Diagnostic Control Agency.




Validation: The validation process isn't the only work of any manufacturing company. The validation work has got to be wiped out in accordance with the rules of the regulatory body and in accordance with the laws of the country. The coronavirus kit won't have equivalent rules because of the blood cholesterol test kit. The principles which will be needed for a heart pacemaker won't be an equivalent because of the principles of a malaria detection kit. The regulatory body will decide where and the way to validate it. They're going to decide what percentage places, what percentage people got to do clinical trials. They're going to decide whether the trial is going to be randomized or blind or test. They're going to investigate whether the merchandise has been manufactured in compliance with the standards and therefore the 'locked' protocol. Moreover, it'll investigate whether there's proper preparation to make sure quality and if there's a system to trace if the merchandise comes within the market but it's defective. Supervise the standard management system (QMS) for internal control of raw materials and made products and whether there's adequate trained manpower. Since no method can provide a 100% sure answer, it's necessary to form sure how effective the merchandise is. The regulatory body will set the ‘pass’ and ‘fail’ criteria. This might vary from country to country, but the standard assurance and approval process are an equivalent.



Some applications and suggestions: Under normal circumstances within the us and Europe, the typical time it takes for diagnostic products and medicines to return to plug is 3-6 years and 12 years, respectively. In these countries, diagnostic products are invented and made consistent with strict standards. Modern advanced treatment isn't possible without a reliable method of diagnosis. Their diagnostic products are standardized because they follow the trail described above - from innovation to marketing. At present, there are deviations within the rules during this worldwide disaster. Coronavirus-related methods for disaster use are rapidly being discounted, and similar measures are being taken to hurry up vaccine and drug research.



The coronavirus detection kit invented at the general public clinic must be validated in accordance with the local law. Care must be taken to make sure that bureaucratic complexities don't get within the way. The method must be transparent and data-centric. However, it should be kept in mind that if the standard is compromised and therefore the production system is faulty, there are often extreme suffering public health.



Coronavirus antibody testing has been introduced abroad. However, they're not yet to be used without the PCR method. This is often the limitation of antibody testing. Antibody tests introduced abroad got to be introduced within the country also and it might not be right to ignore them and just await the domestic method. Since ‘False Positive’ and ‘False Negative’ are more prevalent in antibody testing, and validation process should take a benchmark over the antibody method utilized in Europe and America.



Moreover, there should be clinical trials in multiple centers and on a minimum of 1-2 thousand people. The trial must be randomized or test. ICDDRB may be a universally recognized international research facility in Bangladesh. Incorporating them into the validation process here will increase acceptability.

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It should be noted here that the antibody test is in no way like the PCR test. PCR detects the virus directly, and antibody tests detect immune proteins within the body that attack the virus. And that is why antibody testing can't replace PCR technology. Rather, PCR is that the primary method of detecting the virus. And antibody testing is getting used to verify the extent and prevention of infections within the community. If the virus spreads widely within the society, it is often evaluated with an antibody test.



The price of a PCR kit is far higher but it's not right. Arrangements are often made to form them within the country without counting on 'custom made' PCR. This may reduce the value by 90%. Moreover, the isothermal PCR method can detect the virus in only five minutes. There also are advanced automatic PCR methods that will detect viruses in but an hour without the utilization of hands, these are often run without skilled technicians. The newly invented high throughput PCR machine can test several thousand samples each day. We must consider the utilization of such advanced technologies.



As the nation is embroiled in controversy over the technology, it's the responsibility of the govt and Messrs. Public Health Pharmaceuticals Limited to disclose the matter. There's no place for hiding in science. Only the inventor has the proper to speak about this technology. That's why the inventor has got to begin publicly, otherwise it'll only create unnecessary controversy. Antibody-antigen testing is nothing new, if the protocol is formed public, expert’s reception and abroad will understand and can also cut the fog with this technology.

After all, it's true that we've to avoid all debatings and need to work for the sake of the welfare of individuals and for the country. We've to point out value to scientists and even have to validate their works also. Meaning, we've to take care of a win-win situation for all. Moreover, we must receive the method and decision which is fruitful for all physically, economically, and socially with none risk.

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