Initial product formulation utilizes knowledge acquired from pre-formulation outcomes to derive proper dose, dosage form, and type of administration for the proposed marketed use. A pilot batch of Clinical Trial Materials (CTM) may be produced after Continue Reading...
Cancer Drugs For the past several decades, the news about cancer in the United States has been increasingly positive and that trend has continued unabated over the past decade. According to the National Cancer Institute at the National Institutes o Continue Reading...
14). Soon, Congress passed the Marijuana Tax Act, which was signed into law in 1937. Like the Harrison Act, the Marijuana Tax Act placed marijuana into the same category as the cocaine and opium drugs. It was now illegal to import marijuana into the Continue Reading...
The Orphan Drug Act is an extension of these ethics, but veers away from utilitarianism. The principle at work with orphan drugs is more deontological in its nature because it uses massive amounts of taxpayer money to provide drugs for relatively fe Continue Reading...
It so happened that Russian doctor Karlov was trying to find patients for another clinical trial for an experimental drug, and Ershov fit the requirements to enter the study. "They told me the treatment was safe," says Ershov. "I trust my doctor com Continue Reading...
FDA Drug Approval Process In order for a pharmaceutical company to obtain FDA approval for a new drug, a long sequence of detailed testing and clinical trials must be administered. The approximate cost of putting a new drug through the approval is $ Continue Reading...
Taken in isolation, some of the new, minimally-invasive procedures are less expensive by far, when analyzed on a procedure-by-procedure basis, than previous significant surgical interventions, as demonstrated below: Procedure Cost Estimated durat Continue Reading...
Flow Diagram The author of this report has been to assess a data flow diagram that makes reference to clinical trials. For each step in the clinical trial, the author of this response will speak to what personnel would be involved with that step of Continue Reading...
Drug Use and Abuse Drug abuse Caetano (1997, 58) in his studies describe drug abuse as the poor pattern of substance or drug consumption that results to harm on one's health and when you think about the word drugs, what comes to mind? It's in our h Continue Reading...
Waterfall Methodology and Agile Methodology in Application Development Waterfall methodology represents a process of sequential designing, much like manufacturing and construction workflows. This implies that as each step (idea formation, initiatio Continue Reading...
IV. TESTING ON HUMANS The only thing that is lacking at this point according to all reports is for testing on humans to be completed. The Time Asia articles states: "The last step for the ace-2 inhibitor, as for any drug, is human clinical trials. Continue Reading...
309). The abbreviated approval process authorized by Hatch-Waxman lets generic drug manufacturers use the same clinical data that the original manufacturer used to obtain FDA approval, thereby avoiding these expenses. In this regard, Greene emphasi Continue Reading...
Office Memo Sub: comment on John's claim as a whistle blower against PharmaCARE and the ethical and legal implications of the case As a member of Dewey, Chetum, and Howe you asked me to find out suitable ethical and legal implications that John's c Continue Reading...
Interdisciplinarity of Research of the FDA, its Subsidiaries, and Decision MakingInterdisciplinarity is defined as the combination or combining of two or more academic disciplines to achieve a common task. Using interdisciplinarity a person can make Continue Reading...
Drug Development (From Nature to the Market) The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve nu Continue Reading...
Regulation and Development In general, should the FDA adopt a liberal (increased risk) or conservative (increased safety) approach to approving medical products and why? In accordance to Eichler et al. (2013), drugs are sanctioned by supervisory or Continue Reading...
Direct to Consumer Advertising HISTORY OF DRUG ADVERTISING THE DTC ADVERTISING PHENOMENON CREATING DEMAND DECEPTIVE ADVERTISING - A WOLF IN SHEEP'S CLOTHING CAUSE OF DEATH PROFIT UTILIZATION, PRICING, AND DEMOGRAPHICS LEGISLATION, POLITICS AN Continue Reading...
Economic Evaluation in Drug Development Which form of economic evaluation might be appropriate to assess whether a new me-too drug is cost-effective Me-too drugs are drugs that are anatomically and physically very comparable to drugs that are alrea Continue Reading...
Industry and Regulatory Strategy The generic drug industry provides the public with pharmaceutical alternatives to branded big name prescription drugs. "In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion eve Continue Reading...
new respiratory drugs that have been approved for medical use over the past decade. The paper will highlight the diagnoses of the drugs i.e. when and why it is prescribed, how it is meant to be used and how often, its side effects, the impact for a Continue Reading...
According to these authors, the fatal tragedy could easily have been avoided by taking more time for more focused and carefully planned clinical trials. According to this view, it was unethical to test Tysabri in the way it has been done, and furthe Continue Reading...
Medical Devices The Bleeding Edge is a Netflix film that examines the $400 billion medical device industry, which produces and markets highly complex apparatuses that are implanted into human bodies (Dick, 2018). The documentary was carried out on th Continue Reading...
Vioxx demonstrates the unethical practice perpetuated within the business community. Typically, the pharmaceutical companies often put their financial interests above the health and safety of drug users. The paper also highlighted the unethical drug Continue Reading...
Translating Biomedical Innovation / Mental Health and well being Managing Ideas: Commercialization Strategies for Biotechnology This article by Joshua and Scott Focuses on the commercialization aspect of biotechnology and stresses how important it Continue Reading...
Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for Continue Reading...
Genzyme is a pharmaceutical company based in Cambridge, MA. In 2011, it was acquired for $20 billion by French pharma company Sanofi (Rooney, 2011). Thus, Genzyme is no longer a publicly-traded company, but it is run as an independent subsidiary. San Continue Reading...
This relationship has an effect on the payment rates that CMS sets. Higher cost pharmaceutical therapies are systematically reimbursed below acquisition cost (i.e., the payment system is biased against full reimbursement for higher cost therapies). Continue Reading...
Risk Factors to the Onset of Drug Addiction Drug addiction is one of the subjects whose importance can never be underestimated. Even though this issue is discussed at every forum, the problem persists in the society and needs to be sorted out. It sh Continue Reading...
Teen Drug Abuse - Prescription or Not Differences between nonalcoholic offspring of alcoholics (family history positive, FHP) and matched offspring of nonalcoholics (family history negative, FHN) have been identified on a variety of behavioral, cogn Continue Reading...
Mexico: Terrorism and Organized Crime The convergence in numerous means of organized criminal activities that include terrorism and drug trafficking is a developing concern in the United States and the entire world. Some professionals in this filed Continue Reading...
Bipolar in Adolescence Child Development - Bipolar in Adolescence The early years of the life of a child is full of development and learning, which plays an integral role in building and shaping the entire personality, characteristics and the healt Continue Reading...
Erik Erikson: The Eight Stages of Development Biography Although not as famous as Sigmund Freud, Erik Erikson was no less influential in the development of 20th century psychology. Like Freud, Erikson viewed human beings as developing through a ser Continue Reading...
Pharmacy Ethics The author of this report has been asked to review the legal and ethical considerations in play given the test case scenario surrounding Pharmacare and Compcare. As is quickly apparent while reading the case study, the company engage Continue Reading...
There are many factors that are not dealt with within the ambit of the theory; for example the extent to which the Hispanic culture has become a part of the mainstream culture. Therefore there are many critics of this theory who believe that it is a Continue Reading...
Unlike six-year-olds, whose development is much the same in both sexes, ten-year-old girls and ten-year-old boys develop differently, especially in terms of physical development. Ten-year-old girls begin to experience more growth spurts, growing fa Continue Reading...
Scientology Introducing a New Religious Movement, one must be as objective as possible. I, for instance, could choose to tell you that L. Ron Hubbard founded the Church of Scientology in 1954 and marketed it as an organization for social reform that Continue Reading...
Sports Participation And Character Development sports participation CHARACTER DEVELOPMENT Opening statement Summary of the literature framing history of the project, using 5 articles related to the problem Gaps and/or deficiencies in prior rese Continue Reading...
Sexual Child Abuse Child sexual abuse involves a broad range of sexual behaviors that take place between a child and an older person. These sexual behaviors are planned to erotically stir the older person, commonly without concern for the consequenc Continue Reading...
Business -- Organizational Development Cases Study The organizational entity involved in this case study is a component of the largest Office of Inspector General (OIG) of any United States federal government agency. Specifically, the entity is the Continue Reading...
Research Proposal Option: Proposal to Conduct an Evaluation(Evaluation Template)Proposed Outcomes Evaluation of the Maryland Department of Housing and CommunityDevelopments Homelessness Solutions ProgramHM893January 26, 2024Note: You are provided rec Continue Reading...
