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The pharmaceutical industry presents unique challenges for business research. Like most enterprises today, quality control and zero defects is essential. But drug manufactures are dealing with life-and-death matters on a daily basis regarding product consistency: an individual who takes too much or too little of his or her needed dose because of a deteriorated drug could have his or her health severely compromised, and legal repercussions are the likely result for the company. Additionally, products even within batches can change over time, so even an initially 'perfect' product may show signs of degradation. In the interests of consumer safety, the effects of such degradation must be anticipated through statistical means, but it remains controversial as to what is the best way to accomplish this.
The article uses hypothetical examples, rather than a real world case study to illustrate how different statistical...
Ultimately, the authors conclude that more work needs to be done. "Identifying OOT stability results is a growing concern for FDA and the pharmaceutical industry. Ideally, the method to determine an OOT alarm should not be too complex. However, something too simplistic," such as a certain percentage change for all properties of a drug, "may not be sensitive enough to identify a true OOT or may give a high rate of false signals" (Alasandro et al., 2003, p.48). Current methods, of testing for quality and depreciation of quality over time tend to err on one side or the other. Stability of the drug is usually the most reliable component to test, however other aspects, particularly within-batch results, are troublingly more difficult to implement than the between-batch methods "because of the sparse data within a batch, especially at early time points" (Alasandro et al., 2003, p.52).
A regression chart, a statistical by-time-point approach (to determine whether a result is within expectations in comparison with other batches measured at the same time), and a slope control chart method are all ways to examine the significance of deviations. Degradation of quality is of particular concern for pharmaceuticals, and "unlike batch-release results, which represent one point in time for a batch, stability results may change over the shelf life of the batch" (Alasandro et al.,, 2003, p.48). Thus while determining whether a batch is of a particular level of quality is vital, even more challenging is the question of how to anticipate significant changes in the quality of the medication over time.
The pharmaceutical industry presents unique challenges for business research. Like most enterprises today, quality control and zero defects is essential. But drug manufactures are dealing with life-and-death matters on a daily basis regarding product consistency: an individual who takes too much or too little of his or her needed dose because of a deteriorated drug could have his or her health severely compromised, and legal repercussions are the likely result for the company. Additionally, products even within batches can change over time, so even an initially 'perfect' product may show signs of degradation. In the interests of consumer safety, the effects of such degradation must be anticipated through statistical means, but it remains controversial as to what is the best way to accomplish this.
The article uses hypothetical examples, rather than a real world case study to illustrate how different statistical methods can be used to test for drug quality. Ultimately, the authors conclude that more work needs to be done. "Identifying OOT stability results is a growing concern for FDA and the pharmaceutical industry. Ideally, the method to determine an OOT alarm should not be too complex. However, something too simplistic," such as a certain percentage change for all properties of a drug, "may not be sensitive enough to identify a true OOT or may give a high rate of false signals" (Alasandro et al., 2003, p.48). Current methods, of testing for quality and depreciation of quality over time tend to err on one side or the other. Stability of the drug is usually the most reliable component to test, however other aspects, particularly within-batch results, are troublingly more difficult to implement than the between-batch methods "because of the sparse data within a batch, especially at early time points" (Alasandro et al., 2003, p.52).
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). Reimbursement compared to acquisition cost for the top IO pharmaceuticals by total expenditures indicates that 9 of the 10 are significantly under reimbursed." Clinical Trials Report: Congress established Medicare beneficiaries numbering 40 million with a prescription
38 per share on the company's common stock for the first quarter of 2005. The dividend is payable January 3, 2005 to stockholders of records at the close of business on December 3, 2004. Growth in the ZETIA and VYTORIN franchises are expected to continue. T There are currently several candidates in Phase III that Merck plans to file in 2005 as well as Type 2 diabetes treatment and three vaccines.
There are two constant irritations in U.S. pharma companies' relationships internationally: Some developing nations, such as India, Brazil and South Africa, are chipping away at the patent situation, trying to shorten the time until the drugs can be brought out in generic form. The U.S. has supported high prices as the cost for innovation. Since other countries are not playing along, this means that their citizens are benefiting from the innovation paid
For example, before its paten ran out, "the price of Schering-Plough's top-selling allergy pill, Claritin, was raised thirteen times over fives years, for a cumulative increase of more than 50%, over four times the rate of general inflation." In 2002, the average price of the fifty drugs most used by senior citizens was approximately $1,500 for a year's supply, and although this refers to what the companies call the
McKesson Corporation (Mckesson) is an American pharmaceutical distributor with operations mainly in the U.S. The firm has been in operation since 1833, and boasts extensive market share, robust financial strength, and strong market power. The firm has built strong relationships with its key stakeholders, which adds to its strengths. Nonetheless, limited diversification and market focus as well as the threats of competition, unfavourable regulatory changes, and counterfeits present significant concerns
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 numerous phases of testing and clinical trials, close monitoring of the drug's effects on users, its stability, dosage forms (the preparation), and so on. This paper will describe the drug development process,