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A Medicine Goes to Market place: From Clinical Research to the Pharmacy


6/24/2013 10:18:58 AM

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June 24, 2013 -- There is nothing particularly innovative when it relates to product testing in everyday commerce. The Pharmaceutical and Bio-Tech industry want to know if their items can be sold efficiently, who their intended market is, and how the items will sustain in numerous situations. The only risk which will come from lack of appropriate testing might be poor sales. But this isn't generally the case for all sectors.

When it comes to medication, the suitable management of clinical testing is over just good business; it can indicate the difference in the therapy of diseases and the wellness and well-being of a many people already suffering from a medical condition. For this reason, pharmaceutical organizations must undergo rigorous and multi-phase medical testing before marketing a new drug.

Several countries have various laws regarding how a drug is medically tested. These variations range from length of test intervals, amount of test subjects, doses, follow-ups, and the wide range of surprising side-effects that have to be analyzed independently after the drug has been provided. No matter where, however, among the problems when it relates to pharmaceutical testing is what type of topics should be utilized in the test, and to what extent.

Animal testing is the initial phase of testing. The benefit of this is that it removes the risk of causing physical injury to human beings if a drug has dangerous results, though not totally, because not all animals have the similar biological makeup. As for justifications of animal cruelty, animal examining is being restricted, and many rules have been put in position to avoid or limit these claims.

The next phase of testing is First into human testing or Phase I Clinical Trials. CRO’s (Clinical Research organizations) handle this aspect of clinical testing and it is through this phase of research that gives the “go – non go” decision of whether a particular drug can be further tested or developed into medicine that Pharma and Bio-Tech companies can take to market.

How do we know if a drug is being legitimately and ethically tested by Clinical Research Organizations.

Regulatory bodies such as the UK’s MHRA (Medicines and Healthcare products Regulatory Agency) or US FDA (Food and Drug Administration) are responsible for the regulation of all medicines and medical devices within their respective countries, ensuring they are effective and acceptably safe. A license from theses regulatory bodies, also referred to as a marketing authorization, is required before any medicine can be used to treat people in their respective countries. Licenses for medicines are granted only when a product meets high standards of safety and quality and serves for the purpose intended.

As a starting point of the process, companies and/or researchers must apply to the respective regulatory body, e.g. the MHRA, for permission to test new medicines through clinical trials, e.g. if these trials are to be conducted in the UK. In order to obtain permission to run a trial, they must first satisfy the respective regulatory body that they have met strict safety criteria. All results from these trials e.g. how well the medicine works and its side effects, details of what the medicine contains, how it works in the body, and who it is meant to treat, are then sent to the regulatory body for detailed assessment.

From an ethical perspective, looking in the UK for example, The Health Research Authority has established the NRES Research Ethics Committees. NRES RECs protect the rights, safety, dignity and wellbeing of people taking part in research in the National Health Service. NRES RECs review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.

Matt Donald is a regular blog post contributor of early phase studies facts and material. Writing for Richmond Pharmacology, an early phase studies specialist (UK based), and with years of editorial experience in clinical research. “without regulations and ethics, clinical research can be dangerous, with the right experience, monitoring and authoritative procedures in place, clinical research is a stepping stone to the evolution of healthcare and new medicines which is a benefit to human health as a whole”

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