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The modern paradigm of evidence-based healthcare is based on quality research through ethical and well-designed clinical trials. A drug, therapy or medical device has to pass through a series of trial stages before it can be approved for prescribing by medical practitioners. Pertinent to mention in the beginning is the fact that safety, efficacy and pharmacoeconomic data is an ongoing process in the complete life cycle of a drug or medical device with new information accrued during the course, playing a deciding role for continuation of the drug in the market, any change in product label or warnings, or in some cases its withdrawal. Labelling is also a crucial regulatory component focused on by the for medical apparatus. Medical devices, as with any other facilitated apparatus, should be labelled appropriately prior they can be advertised. Appropriate labelling, as stated by the depicts that any materials linked with the device like containers, booklets or other product details should be precise and unbiased. It also should include the complete address of the manufacturing company or distributor. Labelling policies from the also necessitate manufacturers to register other viable functions of the medical device aside from the intended function. You can find here the best labeling company who makes the best quality control stickers<\/span><\/a>.<\/p>\n This brings in the concepts and systems of pharmacovigilance and pharmacoepidemiology which are a vital component of the healthcare enterprise. When someone is serious about breaking free from the grips of medicine , an inpatient drug rehab<\/span><\/a> in South Florida could also be his or her best choice for fulfillment. Being a part of an inpatient drug rehab center means the individual affected by the addiction is being immersed in addiction education, counseling, support groups, and one on one therapy on a day to day. While inpatient drug rehab is usually more intense than outpatient rehab options, studies show that completing a longterm inpatient program can greatly reduce one\u2019s risk of relapsing after rehab is over.<\/p>\n According to the Next Wind Recovery<\/a> clinic, drug addiction must be taken seriously, because it may be a matter of life or death. And while some people believe they will stop using drugs on their own once they are ready, this might be a dangerous option. By checking into drug detox and inpatient drug rehab and therefore the South Florida region, like Legacy Healing Center, people hooked in to drugs are often safely detoxed under the care of leading medical professionals. But detox alone won\u2019t help someone keep off of medicine long term; are often this is often where rehabilitation can be helpful.At Legacy Healing Center, we all know there’s no easy band aid for white plague which is why we’ve created our comprehensive inpatient drug rehab program options that help individuals on all levels \u2013 psychologically, emotionally, physically, etc. Moving forward with a rehab program is tough work, and our trained staff members walk alongside our clients and their families every step of the way.<\/p>\n Nigeria is slowly gaining momentum in clinical trials in Africa. A search made on the US Clinical trials registry clinicaltrials.gov on 26th<\/sup> October retrieved 145 clinical trials. Nigeria also has its own clinical trials registry (nctr.nhrec.net\/index.html) with an open access to all ongoing and completed trials.<\/p>\n James Lind Institute (JLI)<\/a> provides many online courses focussed towards the clinical trials management <\/a>and allied specialties which may be relevant for the developing clinical research industry in Nigeria. Apart from the mainstream clinical trials management courses are also provided for pharmacovigilance and pharmacoepidemiology, medical and scientific writing, clinical data management, quality assurance, regulatory affairs, medico-marketing, medical journalism, pharmaceutical medicine and translational medicine.<\/p>\n Regional differences in susceptibility to various diseases is multifactorial and includes a complex mix of socioeconomic, cultural, environmental and pharmacogenomic factors which define the response to a causative agent of disease. Understandable a new drug, device or therapy needs to be tested in all major populations of the world to gather information of the differences in response it may have due to these factors. The pharmacogenomic differences to drugs by various populations is by far the major and newer paradigm which is influencing the pharmaceutical industry in developing newer small molecule drugs, biologics or devices.<\/p>\n Before a pharmaceutical company proceed to clinical trials, preclinical trials (in vitro<\/em> and in vivo<\/em> animal studies) would have been conducted to obtain data that would justify progression to clinical trials. Clinical trials are broadly categorized into four phases.<\/p>\n Phase I clinical trials are usually conducted on healthy volunteers. Exceptions to this could be oncology drug trials). The objective is to establish the safety and toxicity profile of the test drug. It is also to study the pharmacokinetics and pharmocodynamics of the drug in humans.<\/p>\nClinical Trial Phases<\/strong><\/h2>\n
Phase I <\/strong><\/h3>\n
Phase II <\/strong><\/h3>\n