Case Study : Good Clinical Practice

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.

Evidence Based Practice is beyond the Advanced Nurse Practitioners and the patients, it is more and part of an organizational culture. Advanced Nurse Practitioners have to understand how literature findings can be reviewed in order to determine if they are relevant and clinically significant to the population they serve as your focus on lesbian, gay, bisexual, and transgender (LGBT) community. It is a good idea to use the evidence-based policy to implement and provide education and training. In addition to education and training, the clinical environments need to be change which can change some behaviors towards this

How do they extrapolate their findings from preclinical animal studies to relate to the intended human population (IND application & IND amendments FDA1571/FDA1572 & entire NDA application)? As the experimental drug activity is established in animal models, how do the results of these preclinical animal trials determine whether the drug appears to be safe and show promise of effectiveness in humans and warrants human clinical trials with the experimental drug.

Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).

Weir’s message of perseverant hope most resonates with me due to The Martian’s ability to tie the story of the frontier to a modern scientific endeavor, rather than the naïve dream of a young adolescent. All the Pretty Horses, to me, read more as a cautionary tale of memorializing a nonexistent era and following this misconception until disaster. McCarthy demonstrates John Grady Cole’s growth throughout the novel from believing in the mythic West to slowly realizing the harsh truth that such a place never exists. The Martian, in contrast, tells a story of science, one which I can better contextualize with my twenty-first century worldview. The new frontier of the modern world certainly still fall prey to misconceived notions and conventional

On Tuesday 06/27/2017, veteran Mr. Saenz walked very angrily in my office with his wife about 11:00 AM. I greeted them and offered to sit down; Mr. Saenz and Mrs. Saenz were very upset and asked me where they need to go as they have VA examination, they both said “nobody tells them anything; they have been sitting in waiting room”. They told me that the lady on the desk told them to come to me.

The first phase pertains to the initial investigation of a new human drug. These studies are monitored

Typically, there is a small number of people used in these Phase I trials, between 20 and 80. Phase II trials have more participants(100-300) who have the condition or disease that the product may be able to treat. Researchers want to gather further safety data and preliminary evidence of the drug’s beneficial effects, and they develop and refine research methods for future trials with this drug. If the drug is indicated to possibly be effective during Phase II, given the observed severity of the disease, the drug will progress to Phase III. In Phase III, the drug is studied in a larger number of people with the disease, between 1,000-3,000 usually. The phase further tests the product’s effectiveness, monitors side effects and, in can compare the product’s effects to a standard treatment, if one is available already. Having more participants reveals the less common side effects. Phase II and Phase III clinical trials typically involve a “control” standard. One group is given the drug and the control group is given either a standard treatment for the illness or a placebo. Phase IV is the part of the trial that is sometimes conducted after a product is already approved and on the market. The purpose is to find out more about the treatment’s long-term risks, optimal use, and benefits, or to test the product in different demographics, such as children. Informed consent is the process by which potential participants for a study are given complete information about the study. The informed consent process provides an opportunity for the researcher and patient to exchange information and ask questions. Patients are invited to enter a trial but are not forced to do so. They can consent to participate if they find the potential risks and benefits acceptable. A participant must sign a consent form prior to enrolling in a study before

According to Dr. David Sackett (1996) Evidence Based Practice (EBP) is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

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).

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.

Since I was a young girl, I’ve loved to make things. I was often found doodling intricate patterns all over my notes, crafting collages out of magazine clippings, molding cities out of playdough, and making beautifully detailed cards out of paper. I would draw from life with an imaginative twist, as well as frequently sketch from my manikin. I was interested in many branches of the arts. I did theatre and dance for a number of years as well.

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.

“I wanted you to see what real courage is, instead of getting the idea that courage is a man with a gun in his hand. It's when you know you're licked before you begin, but you begin anyway and see it through no matter what.” This quotation shows that to have courage isn’t always when you are be brave but when you finish something that you start. In the book “To Kill a Mockingbird” By Harper Lee,  Many characters show the trait of courage throughout the book. It also shows many important parts of the book through these quotes that are shown. In the novel To Kill a Mockingbird by Harper lee Atticus shows the trait of courage a lot in the book.  The next two quotes are ones that show that Jen is a person in the novel that shows the trait of