Clinical trial protocol

Phase III Multinational Clinical Trials for Biosimilar USFDA and Health Canada have established exclusive approval pathways for biosimilars, they are not identical copies of their originators but needs to show a highly similar structure and similar clinical efficacy, safety and immunogenicity to their approved reference biologics. The main goal is to approve biosimilars are to reduce the cost and make it available to the large population. Biosimilars also undergo for testing at all stages of…

and clinical trials are essential to have medical drugs that are good, but it seems there are several shortcuts that comprise of pressuring to have results which are favorable, carrying tests on people minus their consent, as well as applying drugs for uses that are not approved (Cavusgil et al., 2014; Shah,…

ethics committee discuss how to determine what is ethical in this circumstance. There were questions from clinical staff at one point, does allowance of experimental clinical trial drug give the patient and family false hope. The drug was to help the patient in the clinical study to cope emotionally. The family had a moral standard, yet how much financial loss occurred from using the clinical trial. What about the other patients whom may have needed to use the experimental drug? Ethically the…

too protect their own interest… (Bloch, J., PhD, McKeever, A., PhD, Bratic, A., PA-C, 2013).” In addition, “when healthcare providers are forced to select alternative chemotherapeutic agents because of unforeseen shortages and choose alternative protocols based on availability…patient safety and care are compromised, which creates substantial ethical and legal issues… (Bloch, J., PhD, McKeever, A., PhD, Bratic, A., PA-C,…

“Will Technology Ruin Your Children’s Development?” published by Dhruvin Patel is a good article for research because the author displays extensive experience in the medical field and uses advanced research. Also, the publication explores the topic through more than one perspective; it is known of the favored side while the opposing side isn’t criticized. Patel’s article is also up-to-date with it being published this year. Furthermore, “Creating Balance in the New Age of Technology” by Jana…

Biopharmaceutics This is the in-vivo or in-vitro study of various physiochemical factors including developmental and design factors affecting the rate and extent of drug absorption with regards to the pharmacological effect of the drug. Biopharmaceutical studies use this result to improve likely problems that could arise from poor drug absorption and increase the bioavailability of newly formulated drugs. The main purpose of biopharmaceutical studies is to increase, monitor and maintain the rate…

Chemistry: Enasidenib is a first in class, a selective allosteric inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) inhibitor discovered at Agios Pharmaceutical, Inc. in the United States of America. Recently, on 1 August 2017, Celgene Corporation and Agios Pharmaceutical in cooperation won the approval for Enasidenib under brand name IdhifaTm for the treatment of relapsed/refractory acute myeloid leukemia. it is a white to off-white crystalline, non hygroscopic powder existing in…

Gugwad, Preetam Shah, Rahul Lodaya, and Chetan Bhat. These Professors are a part of the Department of Pedodontics at BVDU Dental College and Hospital of India. The study was “a randomized controlled trial conducted among two hundred and fifty children between the ages of six and seven years” old (JCDP). At the beginning of the experiment all of the children received oral prophylaxis, proper oral hygiene care instruction, and were evaluated for dental…

design there are different types of approaches to collect data. Experimental study design is used when a researcher is attempting to alter something to verify their hypothesis. The different approaches to this design are; Randomized Controlled Trials (RCT) and Quasi-Experimental Design (UOttawa, n.d.). The basic principles behind RCT applied when a researcher is testing a new drug and its effects. A hypothesis is formed that the drug will have the same effect on the test group as a placebo…

“dummy pill”. Basically, it’s false medication. According to the American Cancer Society website, it defines placebo as “a substance or other kind of treatment that looks just like a regular treatment or medicine, but it’s not. Placebos are used by clinical professionals to make individuals believe that they’re getting help from a “dummy pill”. Many people believe that placebos work because the consumer doesn’t know that it’s fake. This kind of thing is abundantly used and tested to make people…