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By: Pierre Kory, MPA, MD
- Associate Professor of Medicine, Fellowship Program Director, Division of Pulmonary, Critical Care, and Sleep Medicine, Mount Sinai Beth Israel Medical Center Icahn School of Medicine at Mount Sinai, New York, New York
https://www.medicine.wisc.edu/people-search/people/staff/5057/Kory_Pierre
For example quad spasms after squats cheap 200 mg urispas overnight delivery, an average-looking defendant might be judged more harshly when participants have just judged an attractive defendant than when they have just judged an unattractive defendant spasms by rib cage cheap urispas 200 mg fast delivery. Within-subjects experiments also make it easier for participants to spasmus nutans buy cheap urispas 200 mg on line guess the hypothesis. For example, a participant who is asked to judge the guilt of an attractive defendant and then is asked to judge the guilt of an unattractive defendant is likely to guess that the hypothesis is that defendant attractiveness afects judgments of guilt. This could lead the participant to judge the unattractive defendant more harshly because he thinks this is what he is expected to do. Or it could make participants judge the two defendants similarly in an efort to be “fair. Imagine, for example, that participants judge the guilt of an attractive defendant and then judge the guilt of an unattractive defendant. If they judge the unattractive defendant more harshly, this might be because of his unattractiveness. But it could be instead that they judge him more harshly because they are becoming bored or tired. The attractive condition is always the frst condition and the unattractive condition the second. Thus any diference between the conditions in terms of the dependent variable could be caused by the order of the conditions and not the independent variable itself. There is a solution to the problem of order efects, however, that can be used in many situations. It is counterbalancing, which means testing diferent participants in diferent orders. For example, some participants would be tested in the attractive defendant condition followed by the unattractive defendant condition, and others would be tested in the unattractive condition followed by the attractive condition. With counterbalancing, participants are assigned to orders randomly, using the techniques we have already discussed. Thus random assignment plays an important role in within-subjects designs just as in between-subjects designs. Here, instead of randomly 124 assigning to conditions, they are randomly assigned to diferent orders of conditions. In fact, it can safely be said that if a study does not involve random assignment in one form or another, it is not an experiment. One is that it controls the order of conditions so that it is no longer a confounding variable. Instead of the attractive condition always being frst and the unattractive condition always being second, the attractive condition comes frst for some participants and second for others. Likewise, the unattractive condition comes frst for some participants and second for others. Thus any overall diference in the dependent variable between the two conditions cannot have been caused by the order of conditions. A second way to think about what counterbalancing accomplishes is that if there are carryover efects, it makes it possible to detect them. One can analyze the data separately for each order to see whether it had an efect. When 9 Is “Larger” Than 221 Researcher Michael Birnbaum has argued that the lackof context provided by between-subjects designs is often a bigger problem than the context effects created by within-subjects designs. To demonstrate this, he asked one group of participants to rate how large the number 9 was on a 1-to-10 rating scale and another group to rate how large the number 221 was on the same 1-to-10 rating scale (Birnbaum, 1999). Participants in this between-subjects design gave the number 9 a mean rating of 5. According to Birnbaum, this is because participants spontaneously compared 9 with other one-digit numbers (in which case it is relativelylarge) and compared 221 with other three-digit numbers (in which case it is relativelysmall). So far, we have discussed an approach to within-subjects designs in which participants are tested in one condition at a time. There is another approach, however, that is often used when participants make multiple responses in each condition. Imagine, for example, that participants judge the guilt of 10 attractive defendants and 10 unattractive defendants.
Minor muscle relaxant with ibuprofen cheap 200mg urispas visa, National Institute for Biological Standards and Control spasms right side abdomen generic urispas 200mg without prescription, Potters Bar muscle relaxant no drowsiness effective 200 mg urispas, England; Dr S. Morgeaux, Agence Française de Sécurité Sanitaire de Produits de Santé, Lyons, France; Dr S. Pascual, Centro para el Control Estatal de la Calidad de los Medicamentos, Havana, Cuba; Dr M. Wang, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, China; Dr D. Xing, National Institute for Biological Standards and Control, Potters Bar, England. Minor, National Institute for Biological Standards and Control, Potters Bar, England; and Dr C. Milne, European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France, on the basis of comments from national regulators, the vaccine industry and the general public. Lei, World Health Organization, Geneva, Switzerland, and the drafing group, on the basis of comments from the Expert Committee on Biological Standardization and the participants in the Committee meeting of 2009 and comments from the public consultation. Requirements for measles, mumps and rubella vaccines and combined vaccines (live). Guidelines for assuring the quality, safety, and efcacy of human papillomavirus vaccines. Guidelines to assure the quality, safety and efcacy of live attenuated rotavirus vaccines (oral). Recommendations for the preparation, characterization and establishment of international and other biological reference standards. Comparison between in vitro potency tests for Cuban Hepatitis B vaccine: contribution to the standardization process. Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. Examples include: release of vaccine lots in emergency situations such as a vaccine shortage due to a disease outbreak, natural disaster, manufacturing problems. Since each situation is specifc, it is expected that modifcations to the structure and content of this template may be required in order for it to be applicable to diferent issues. Purpose/objective Outline the purpose and/or objectives of this analysis (for instance, to evaluate the consistency of production of a vaccine) and explore whether changes to the frequency of independent testing or elimination of a specifc test are justifed on the basis of the consistency of production. Background Give a brief history of the problem/issue and identify critical information. Justify the results/conclusions with regulatory and scientifc data, including published and unpublished information. Options analysis List all the options considered to address the issue/problem, including the status quo. Recommendations Indicate what the recommendation is and who is responsible for its approval. Implementation and evaluation plan Show how the proposed changes will be implemented in terms of timing, organizational and personnel changes and resource allocation. Indicate when and how the proposed changes will be evaluated and against what benchmarks. Recommendations for the characterization of cell banks of animal cell substrates 123 B. It is recommended that modifcations to these recommendations be made only on condition that the modifcations ensure that the biological product is at least as safe and efcacious as that prepared in accordance with the recommendations set out below. Terefore, a thorough understanding of the characteristics of the cell substrate is essential in order to identify points of concern and to develop a quality control system that addresses these points. Animal cells refer to cells derived from organisms classifed as within the animal kingdom. This document is the result of the Study Group’s work, which included a wide range of consultations with individuals and organizations with expertise in this area. During the development of this document, guidance on the topic issued by other relevant organizations was considered. An efort was made to make the recommendations compatible with existing guidance whenever possible. For instance, in 1954 an experimental adenovirus vaccine was being developed and human tumour cells (HeLa) were rejected as the cell substrate in favour of “normal” cells (2). At that time, relatively little was known about the 84 Annex 3 biological mechanism(s) that lead to human cancer, so the risks to the recipients of a vaccine based on HeLa cells could not be assessed and quantifed scientifcally.
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After the brand drug is launched spasms in upper abdomen buy urispas 200 mg with mastercard, its revenues cover its operating costs each year with the remaining operating profit contributing to muscle relaxant methocarbamol urispas 200mg for sale the recoupment of the investment costs muscle relaxant and pregnancy 200 mg urispas sale. The original Nature model assumes that the contribution margin for the biologic portfolio is -30% in the first year after launch, +20% in the second year after launch, and +50% thereafter. The steady-state 50% margin is used because it is “in line with the contribution margins realized by the eight largest biotechnology firms with multiple products on 11 the market. Discount Rate/Cost of Capital the final input of the Nature model is an estimate of the cost of capital for a biologic drug, i. The original Nature model uses two rates to “capitalize forward” the R&D cost stream to the launch date and discount the profit stream back to the launch date: 11. These rates are justified as “reflective of the equity cost of capital for larger 12 publicly listed biotechnology firms with multiple products on the market in recent periods. These six components are used to calculate the point at which R&D costs are recouped through post-approval cumulative profits as shown in Table 1 below (which assumes a discount rate of 11. To properly compare profits in different years, this profit stream is discounted back to the launch date. Summary of Comments Commenters raised several issues about the inputs, the operation of the model, and the inferences that can be drawn from the model. Alex Brill arrived at different results by varying 16 some of the model’s assumptions. First, he suggested that 10% is a more accurate estimate of 17 the cost of capital for biotech firms, rather than 11. Second, he posited that 60%, 18 rather than 50%, is a more accurate estimate of the contribution margin for a large biotech firm. The original Nature model and subsequent calculations exclude only the bottom quintile of biologic drugs when constructing the portfolio. In addition to his original calculation (which assumes total market revenues do not change), he presented additional break-even calculations that assume a perfectly inelastic demand. One of these assumes a steady-state price decline of 40% as before and the other assumes a steady-state price decline of 20%. A-6 calculations assume seven years of branded exclusivity, a contribution margin of 60%, and a cost of capital of 10%. With these assumptions, he finds that the branded manufacturer breaks-even nine to 14 years after launch. Reasonable changes to these assumptions can easily affect the results by 25 30–40 percent. Problems with the Break-Even Model Analysis the problems with the Nature model fall into three types: (1) problems with the “inputs” to the model. Problems with the Input Assumptions the first input to the Nature model is the estimate of pre-approval R&D costs for a representative biologic drug. The problem with this estimate is that it is based on a sample of 26 only 17 drugs. Unless the R&D costs within each clinical phase are essentially identical across the drugs, it is likely that the confidence interval around the R&D cost estimate is large and, thus, the R&D cost estimate is less likely to be accurate. Further, 13 of the 17 drugs were developed by one firm and the sample is restricted to therapeutic recombinant proteins and monoclonal antibodies, so it is possible that the sample is non-random and not representative of biologic drugs overall. Another important input into the model is the revenue stream of the representative biologic drug. There are two potential problems with the revenue stream used in the Nature 27 model. First, the revenue stream includes sales from post-approval indications and 28 formulations in addition to the original indication/formulation. The revenue stream associated with the original indication/formulation is not provided, so one cannot calculate the break-even point of the original indication/formulation with the data in the model. Accordingly, there could be additional weaknesses in the Nature model concerning its treatment of international revenues.
The organization of the red and green pigment genes in men with normal vision is illustrated in Figure 7 muscle relaxant parkinsons disease buy urispas 200mg cheap. Unex-pectedly spasms from colonoscopy purchase urispas 200 mg on-line, a significant proportion of normal X chromosomes contain two or three green-pigment genes spasms throughout my body buy generic urispas 200mg on line. The red-pigment and green-pigment genes pair and the crossover takes place in the region of homology between the genes. The result is a duplication of the green pigment gene in one chromosome and a deletion of the green-pigment gene in the other. The recombinational origins of the defects in color vision are illustrated in Figure 7. If the green-pigment gene is missing, or if the chimeric gene is largely "red" in its sequence, then deuteranopia is the result. If the chimeric gene is largely "green" in its sequence, then deuteranomaly is the result. If the chimeric gene is largely 'green," then protanopia results; if it is largely "red," then protanomaly results. Note that the red gene cannot be eliminated altogether (as the green gene can), because the red gene is at the end of the region of homology between the chromosomes pigment gene shown earlier in Figure 7. Crossing-over between the genes yields a chimeric gene, which is a composite gene: part of one joined with part of the other. The chimeric genes are the reciprocal products of the unequal crossovers that yield defects in green vision. Some chromosomes contain one copy of the green-pigment gene, others two, still others three. Note that one product of unequal crossing-over is a chromosome containing a red-pigment gene but no green-pigment gene Page 286 Figure 7. Inversions Another important type of chromosome abnormality is an inversion, a segment of a chromosome in which the order of the genes is the reverse of the normal order. In an organism that is heterozygous for an inversion, one chromosome is structurally normal (wildtype), and the other carries an inversion. These chromosomes pass through mitosis without difficulty because each chromosome duplicates and its chromatids are separated into the daughter cells without regard to the other chromosome. The problem is that the chromosomes are attracted gene for gene in the process of synapsis, as shown in Figure 7. In an inversion heterozygote, in order for gene-for-gene pairing to take place everywhere along the length of the chromosome, one or the other of the chromosomes must twist into a loop in the region in which the gene order is inverted. The looping apparently takes place without difficulty and can be observed through the microscope. As long as there is no crossing-over within the inversion, the homologous chromosomes can separate normally at anaphase I, as illustrated in Figure 7. On the other hand, when there is crossing-over within the inversion loop, the chromatids involved in the crossing-over become physically joined, and the result is the formation of chromosomes containing large duplications and deletions. One of these contains the inverted sequence and the other the normal sequence, as shown in Figure 7. Because of the crossover, the inner chromatids, which did participate in the crossover, are connected. If the centromere is not included in the inversion loop, as is the case here, then the result is a dicentric chromosome. Neither the dicentric chromosome nor the acentric chromosome can be included in a normal gamete. The acentric chromosome is usually lost because it lacks a centromere and, in any case, has a deletion of the a region and a duplication of the d region. The dicentric chromosome is also often lost because it is held on the meiotic spindle by the chromatid bridging between the centromeres; in any case, this chromosome is deleted for the d region and duplicated for the a region. Hence, when there is a crossover in the inversion loop, the only chromatids that can be recovered in the gametes are the chromatids that did not participate on the crossover. In the early years of genetics, before their identity as inversions was discovered, inversion-bearing chromosomes were known as "crossover suppressors.
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