The development and evaluation of Januvia® (Sitagliptin Phosphate) are illustrative of the activities that are needed to assess the efficacy, safety and effectiveness of a new product for treating type 2 diabetes milieus. It is the first drug of dipeptidyl peptidase-4 (DPP-4) inhibitors class that is approved as an adjunct to diet and exercise to improve the glycemic control.1 Januvia was developed by Merck Research Laboratories and received the FDA approval on 16 October 2006.2 Preclinical/Animal study: The animal study of MK-0431, the code name for Sitagliptin in early development phase, was done in mice, rat, and dog. Maximum recommended daily adult human dose (MRHD) of Sitagliptin was found 100mg/day and NOAEL 50mg/kg based on dog study.3 Two years of carcinogenic study was conducted on mice and rat. In rat, liver adenoma/carcinoma has been seen at 60 times of MHRD. This is probably due to chronic hepatotoxicity of the drug. No tumor incidence was observed in case of mice up to 70 times of MHRD. Both in vitro assay and in vivo mice assay was not suggestive of mutagenic and clastogenic nature of MK-0431. Fertility adverse effect was also not at 12 times of MHRD)3 and Sitagliptin was labeled as pregnancy category B.4 Based on these preclinical studies on animal, Merck submitted their Investigational New Drug (IND 65, 495) application to FDA was on August 2002.4 Phase I: Phase I of Sitagliptin study was done on 33 volunteer humans. Following 100mg of Sitagliptin oral
The biggest issue with VPN connectivity or MDM registration is the network connection the devices have. One way to mitigate the VPN connection is to enable mobile hotspot services on the mobile device. The employee could then connect the laptop to the mobile hotspot to VPN across as long as there is a strong enough cellular signal in that area. For the mobile device, if cell signal is poor, you can turn on wireless and connect to the wireless network if one is available. This would allow the device to register to MDM for monitoring. If continued connectivity issues are being noticed by employees, they should take the devices in to an administrator for further observation. A rollback of the configuration of the devices to a default state
MR. David likewise takes atorvastatin (Lipitor); 10 mg every day, for hypercholesterolemia (hoisted LDL cholesterol, low HDL cholesterol, and raised triglycerides). He has endured this medicine and holds fast to the day by day plan. Amid the previous 6 months, he has likewise taken chromium picolinate,
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.
This project seeks to provide a brief overview of what a new drug has to go through before it hits the streetsstarting with the manufacture, preclinical or clinical trials, documentation, registration, review, approval, marketing, &distribution; focusing on tests they have to hurdle. Another aim would be to identifya drug that binds itself to the SGLT2 & inhibits its function. The researcher has found that Dapagliflozin of the Gliflozin class of antidiabetic medications is anSGLT2 inhibitor. This paper will define keywords, explain the action, enumerate preclinical &clinical trials that have to be undergone before the FDA deems it safe for human consumption; with the ultimate goal of getting the product approved, marketed, &distributed in the US& elsewhere. There are no participants [animal or human] in this report. This
announced its intention to submit an application to the U.S. Food and Drug Administration (FDA)
IND application submitted with pre-clinical safety data of pharmacology and toxicology study gathered during a clinical trial in an animal, drug composition, information of manufacturers, stability of the drug, and controls utilized to process the drug, a constant supply of batches, a copy of clinical protocols which has been permitted by the Institutional Review Board (IRB), and s information regarding investigators who is conducting the clinical trials (Manuts, 2008). Good clinical practices (GCPs) are followed in all phases of clinical trials conducted in human by law of the human subject protection (HSP) stated in the CFR 45, Part 46. The FDA website, the Clinical Trials.gov offers to register the clinical
We are focusing our clinical trial trail phase III study trials in USA, Japan and Germany as we have checked feasibility for those countries for Type II Diabetes Mellitus (T2DM) patients who have been prescribed Kombiglyze XR by their physician for the treatment regime and how it is responsible to induce the heart related diseases. We will conduct Phase 3 clinical trial with time limit of 2 years.
Furthermore, with the pharma logical treatments included in this article for the treatment of Type 2 Diabetes, many individuals will be prevented from developing CVD complications. Studies have shown the importance of patients being compliant with treatment leading to positive health outcomes. With the continued care given to these patients with Type 2 Diabetes many are able to have healthier lifestyles
The KEYNOTE-024 trial was designed by Merck representatives and academic advisors. According to European legislation, Merck, as the Sponsor, designated, per country, a national principal coordinator, responsible for coordinating the work of the principal investigators at the different trial sites in each member state of the multicentre trial, according to national regulations. Each coordinator agreed to allow: 1) the respect of local laws, rules and regulations relating to the conduct of the clinical trial; 2) a regulatory authority inspection of trial-related documents and procedures and 3) the access to all trial-related source data and documents. The Code of Conduct, a collection of goals and considerations that govern the ethical and scientific
The new drug sponsor then submits an Investigational New Drug Application (IND) to FDA based on all data gathered from initial animal testing, including a pharmacological profile of the drug, information about the drug composition and manufacturing, and a plan for the initial phase of clinical trials to test the drug on human without exposing them to unnecessary risks. Additionally,
For secondary endpoints, there was a significant reduction in FBG at week 18 (p< 0.025 for both doses).2 There was a dose-dependent reduction in the strata of metformin + sulfonylurea while it was dose-independent in strata of metformin alone.2 For body weight endpoint, there was a significant, dose-dependent body weight reductions (p< 7% with either canaglifozin doses.2 Other benefits included significant body weight reductions, clinically important decreases in systolic blood pressure, increases in HDL cholesterol and decreases in TG.2 The drug was well-tolerated with low rate of
DPP-4 inhibitors enhance the body's own ability to control blood glucose by increasing the active levels of incretin: glucagen like peplide l (GLP-l), glucose- dependent insulintropic polypeptide (GIP) hormones in the body. Their mechanism of action is distinct from any existing class of oral glucose-lowering agents. They control elevated blood glucose by triggering pancreatic insulin secretion, suppressing pancreatic glucagon secretion, and signaling the liver to reduce glucose production (Barnett, 2006).
According to The State Family Commission off China tap water coverage has dramatically increased in a ten year span by 10% from 84% up to 94%.
As public health professionals we have a Code of Ethics that dictates how we should care for the community. The Code of Ethics and Healthy People dictates inclusion of all people not relative to gender, race or religion (Healthy People 2020). Health educators, as their Code of Ethics dictates should be influenced by facts and evidence irrespective of their social or moral views, just as Healthy People uses measurable goals and data to shape public policy. For example, political agendas can trump best health interests of minorities and the disadvantaged. Kass (2001) states, “public health has affirmative obligations to improve the public’s health and arguably, to reduce certain social inequities”.
This is a paper to assist a fifty-two year old, widowed white woman, with two young children to assist her on her cessation to smoking. She states that she has been smoking since was seventeen years old and smokes a pack a day. She states that she would like to stop smoking because she would like to have a ‘healthier lifestyle’. She works full-time in an administrative position in a nursing facility. She does not have a support system in the home but does have support from friends in community and fellow workers at her place of employment.