While critiquing medical anthropology, a subfield of anthropology that analyzes how different factors influence population health, pharmaceutical spheres are often overlooked in the way drugs are distributed and manufactured; there are distinctive agents that explain how a pharmaceutical territory could become an environment with a disrupted drug distribution system and with neglect for the impoverished. In 1990s Nigeria, its national drug market constituted around 30 to 70 percent of fake drugs (Peterson 6). Numerous drug markets were also run by criminals who facilitate activities in the wholesaling process of distributions (Peterson 16). Likewise, homeless AIDS patients in Brazil were outcasted from access to ARVs as an universal health therapy (Biehl 1112). All of these facts are pervasive threats to the integrity of human health. Therefore, neighborhoods involving pharmaceuticals demoralize fragile populations through the implications of how clinical trials exploit treatment naive populations, the everyday risk of how traders speculate pharmaceutical markets, and the disturbance of how structural violences reveal a sense of injustice for drug resistance treatment. Clinical trials are often practiced in determining whether a drug is validated for safe and effective distribution. They are branched into three stages and are generally sponsored by biotechnological companies (Rajan 67). The first and second stages are to determine whether the drug molecule is safe for
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There are four stages for a new drug to be approved by the FDA. The first stage is pre-clinical investigation. During this stage, researchers need to find out if a new drug can cause harm to people before testing it. There are two types of preclinical research. They are In Vitro and In Vivo. Preclinical studies are not very big. These studies give information on dosing and the poisonous levels. The researchers read over what they found and make a decision on whether the drug should be tested.
During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.
There are several phases and applications to complete for drug development in the United States. The three basic stages in the testing process are preclinical, clinical, and approval. The first step of preclinical usually lasts anywhere from one to six years. During the preclinical phase, toxicology studies on the ingredients are collected and drug testing
Social conflicts and struggles are an inevitable part of any society in any country. These struggles can include an increased rate in crime, unemployment, domestic/general violence, and overall civilian depression. When governments cannot seem to find a means to an end, they often turn and look for something to blame for their struggles, and that thing is more often than not, drugs. For many years, several opiates and drugs were primarily used for medicinal purposes, were seen to have an abundance of health benefits and was widely accepted among communities. Although, with the increasing social conflicts and economic conditions, authorities turned to and targeted many different forms of once accepted drugs, and made them the scapegoat for the problems they were facing.
Recent working experience for 21 months as a study coordinator at the cancer centre of Seoul National University Hospital has given me a greater passion for expanding my career of proficiency and growing my expertise in pharmaceutical research area. This experience also led to me learning much about not only the patients journey from diagnosis to chemo/radiotherapy but also whole process of clinical trials. I am familiar with a clinical trial protocol,
“Drugs continue to kill … 200,000 people a year, shattering families and bringing misery to thousands” states Yury Fedotov, the Executive Director of the UN Office on Drugs and Crime (UN 2012). A modern crisis, drug abuse takes the will and freedom of hundreds of thousands, plunging their lives into despair. But this is only one side of the coin; those who supply the hazardous euphoria of drugs build their own volatile empires on foundations of violence and deceit. Authoritarian leaders build on these worlds to create systems of power in drug cartels, concentrating their power to even control full regions. They aim to dominate the drug market , flouting law and order in their vehement rise to
In Phase I study the safety of a drug or device is a priority and this initial testing phase can take several months to complete and generally includes 20 to 100 paid healthy volunteers in study. The design of the study is to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. The investigation of a side effects also observed by an increasing the drug doses. Not all drugs are passing during this phase, but nearly 70% of
The first step in developing a clinical trial is the doctor’s idea for a new treatment. Once it is determined to be scientifically viable and after several committee meetings, a protocol is developed. A protocol is the official playbook or system of rules governing each step of treatment or intervention from beginning to end. The protocol also explains the history of the disease and the treatment drug being used in the trial. Also discussed are the primary endpoint and all endpoints thereafter and lays out the statistical considerations before the trial begins. This is a very intricate part of creating clinical trials
Pierce (2003) described that understanding an individual’s personally interpreted meaning of an experience is critical for occupational therapists. An individual is considered as loci of an experience. As occupational therapists, we appreciate the contextual dimensions (spatial, temporal, sociocultural) that can influence an individual’s occupational experience. Pierce (2003) emphasizes that descriptive research in occupational science can help researchers understand the dynamics of occupation in an individual’s life. In contrast, medical anthropology is focused on the interpretation of behaviors based on a cultural group or a sub-group. According to Leavitt (2010), medical anthropologist takes an interpretive or cultural constructivist approach of the study of disability, focusing on the symbols, values, attitudes and reactions associated with the experience of disability (p. 28). Medical anthropology also emphasizes on politics and socio-economical diversities that influences health, illness, disability and healthcare delivery system.
After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.
Anthropology is a diverse area that covers many aspects of the society. In most cases, anthropology covers the social interactions, the linguistic relations and physical relations among members of the society. Healthcare administration deals with planning, monitoring and facilitating the provision of proper healthcare services in the society by healthcare providers such as hospitals. There are many ways in which anthropology may help to facilitate effective healthcare administration. However, the application of anthropology in the field of healthcare administration also varies among different societies.
Whilst it is widely recognised that clinical trials are needed to develop new medicines, they also lead to an improvement in medical care more generally. The new regulation aims to remove the barriers to clinical research across Europe by-
The discovery of a new drug without involving human subjects is called as non clinical studies. Goals of non-clinical testing of Biologics are: characterization of probable undesirable drug effects, identifying toxicities on organs, identifying convertibility of toxicity , characterization of pharmacokinetic report, characterization of favorable pharmacodynamic effects -proof of standard, guideline for safe application in human clinical studied, determination of a safe and practical starting dose, and offer monitoring strategy for the clinical study, offer adequate clinical data to conclude
As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).
I am a woman born in a district next to border of Thailand and Cambodia who move around for study and work in Central, North, and South. To learn local culture by observe and participate with local people is one of my preference along the time I was being there. Therefore, even I am working to reserve threatened bird, I also encourage on learn people’s culture in surrounding community as my recreation.