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Each of these values should be interpreted as a pair of values: one positive and one negative blood pressure medication raises pulse generic valsartan 80 mg with amex. For example blood pressure chart video order valsartan 160mg on-line, the two-tailed critical values when there are 24 degrees of freedom are +2 blood pressure monitor reviews valsartan 80mg with amex. The idea is that any t score below the lower critical value (the left-hand red line in Figure 13 blood pressure medication that does not cause joint pain buy discount valsartan 40mg online. This means that any t score beyond the critical value in either direction is in the most extreme 5% of tscores when the null hypothesis is true and therefore has a p value less than. Thus if the t score we compute is beyond the critical value in either direction, then we reject the null hypothesis. If the tscore we compute is between the upper and lower critical values, then we retain the null hypothesis. This makes sense when we believe that the sample mean might difer from the hypothetical population mean but we do not have good reason to expect the diference to go in a particular direction. But it is also possible to do a one-tailedtest, where we reject the null hypothesis only if the t score for the sample is extreme in one direction that we Chapter 13 301 specify before collecting the data. This makes sense when we have good reason to expect the sample mean will difer from the hypothetical population mean in a particular direction. A t score below the lower critical value is in the lowest 5% of the distribution, and a tscore above the upper critical value is in the highest 5% of the distribution. Notice that we still reject the null hypothesis when the tscore for our sample is in the most extreme 5% of the t scores we would expect if the null hypothesis were true—so α remains at. If the sample mean difers from the hypothetical population mean in the expected direction, then we have a better chance of rejecting the null hypothesis. The disadvantage is that if the sample mean difers from the hypothetical population mean in the unexpected direction, then there is no chance at all of rejecting the null hypothesis. Imagine that a health psychologist is interested in the accuracy of college students’ estimates of the number of calories in a chocolate chip cookie. He shows the cookie to a sample of 10 students and asks each one to estimate the number of calories in it. Because the actual number of calories in the cookie is 250, this is the hypothetical population mean of interest . Because he has no real sense of whether the students will underestimate or overestimate the number of calories, he decides to do a two-tailed test. Now imagine further that the participants’ actual estimates are as follows: 250, 280, 200, 150, 175, 200, 200, 220, 180, 250. Finally, if this researcher had gone into this study with good reason to expect that college students underestimate the number of calories, then he could have done a one-tailed test instead of a two-tailed test. This slightly less extreme value would make it a bit easier to reject the null hypothesis. However, if it turned out that college students overestimate the number of calories—no matter how much they overestimate it—the researcher would not have been able to reject the null hypothesis. The dependent-samples t test (sometimes called the paired-samples t test) is used to compare two means for the same sample tested at two diferent times or under two diferent conditions. This makes it appropriate for pretest-posttest designs or within-subjects experiments. The null hypothesis is that the means at the two times or under the two conditions are the same in the population. This test can also be one-tailed if the researcher has good reason to expect the diference goes in a particular direction. It helps to think of the dependent-samples t test as a special case of the one-sample ttest. However, the frst step in the dependent-samples ttest is to reduce the two scores for each participant to a single diference score by taking the diference between them. At this point, the dependent samples ttest becomes a one-sample t test on the diference scores. The hypothetical population mean of interest is 0 because this is what the mean diference score would be if there were no diference on average between the two times or two conditions. We can now think of the null hypothesis as being that the mean diference score in the population is 0 (= 0) and the alternative hypothesis as being that the mean diference score in the population is not 0 (≠ 0). Imagine that the health psychologist now knows that people tend to underestimate the number of calories in junk food and has developed a short training program to improve their estimates. To test the efectiveness of this program, he conducts a pretest-posttest study in which 10 participants estimate the number of calories in a chocolate chip cookie before the training program and then again afterward. Because he expects the program to increase the participants’ estimates, he decides to do a one-tailed test. Now imagine further that the pretest estimates are Chapter 13 303 230, 250, 280, 175, 150, 200, 180, 210, 220, 190 and that the posttest estimates (for the same participants in the same order) are 250, 260, 250, 200, 160, 200, 200, 180, 230, 240. The diference scores, then, are as follows: +20, +10, −30, +25, +10, 0, +20, −30, +10, +50. Note that it does not matter whether the frst set of scores is subtracted from the second or the second from the frst as long as it is done the same way for all participants. In this example, it makes sense to subtract the pretest estimates from the posttest estimates so that positive diference scores mean that the estimates went up after the training and negative diference scores mean the estimates went down. The independent-samples t test is used to compare the means of two separate samples (M1and M2). The two samples might have been tested under diferent conditions in a between-subjects experiment, or they could be preexisting groups in a correlational design. Again, the test can be one-tailed if the researcher has good reason to expect the diference goes in a particular direction. The t statistic here is a bit more complicated because it must take into account two sample means, two standard deviations, and two sample sizes. The formula is as follows: 304 Notice that this formula includes squared standard deviations (the variances) that appear inside the square root symbol. Also, lowercase n1 and n2 refer to the sample sizes in the two groups or condition (as opposed to capital N, which generally refers to the total sample size). The only additional thing to know here is that there are N− 2 degrees of freedom for the independent-samples t test. Now the health psychologist wants to compare the calorie estimates of people who regularly eat junk food with the estimates of people who rarely eat junk food. He believes the diference could come out in either direction so he decides to conduct a two-tailed test. He collects data from a sample of eight participants who eat junk food regularly and seven participants who rarely eat junk food. The data are as follows: Junk food eaters: 180, 220, 150, 85, 200, 170, 150, 190 Non–junk food eaters: 200, 240, 190, 175, 200, 300, 240 the mean for the junk food eaters is 220. The fact that his t score was more extreme than this critical value would tell him that his pvalue is less than. The null hypothesis is that all the means are equal in the population: µ1= µ2 =…= µG. It is a ratio of two estimates of the population variance based on the sample data. The precise shape of the distribution depends on both the number of groups and the sample size, and there is a degrees of freedom value associated with each of these. The within-groups degrees of freedom is the total sample size minus the number of groups: Again, knowing the distribution of F when the null hypothesis is true allows us to fnd the p value. In the unlikely event that we would compute F by hand, we can use a table of critical values like Table 13. The idea is that any F ratio greater than the critical value has a p value of less than. Thus if the F ratio we compute is beyond the critical value, then we reject the null hypothesis. If the F ratio we compute is less than the critical value, then we retain the null hypothesis. Imagine that the health psychologist wants to compare the calorie estimates of psychology majors, nutrition majors, and professional dieticians. He collects the following data: Psych majors: 200, 180, 220, 160, 150, 200, 190, 200 Nutrition majors: 190, 220, 200, 230, 160, 150, 200, 210, 195Dieticians: 220, 250, 240, 275, 250, 230, 200, 240 the means are 187. So it appears that dieticians made substantially more accurate estimates on average.


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The increased averaging time addresses typical expected transient exposures to heart attack test valsartan 160mg line E Þelds in uncontrolled environments hypertension case study purchase 40mg valsartan visa. For exposures to blood pressure stages cheap valsartan 80mg with mastercard low-frequency magnetic Þelds where the limits are the same for both controlled and uncon trolled environments printable blood pressure chart uk buy 40mg valsartan mastercard, the averaging time is the same, i. H Þelds heat biologic tissue and induce internal currents less effectively than E Þelds. Since the time averaging of induced currents is over a period of 1 s, the likelihood of permitted exposures to E or H Þelds greatly exceeding the long-term limits is small and restricted to special situations. For some time, it has been recognized that the lack of such consider ation in the standard has allowed the peak power density to rise arbitrarily, as long as average power density met the standard. For a single pulse, this is equivalent to reducing the maximum permissible peak power density by a factor of Þve times below the value that normal time averaging would permit. A maximum of Þve such pulses are per mitted during any period equal to the averaging time. If there are more than Þve pulses in any period equal to the averaging time, normal time-averaging will further reduce the permissible peak power density. The limits on peak power are the values obtained by consideration of a well-established scientiÞc base of data that includes the auditory effect in humans and radio-frequency energy-induced unconsciousness in rats (see Chou et al. The recommen dation for a peak E-Þeld limit of 100 kV/m is based on the necessity to cap the allowable Þeld below levels at which air breakdown or spark discharges occur. The level chosen is ultraconservative in this regard, and represents an absorbed energy that is also more conservative than the continuous-wave limit over pulse lengths for which it is intended. This conservatism is prudent in light of the relative sparseness of studies for very short high-intensity exposures. Such studies as do exist are reassuring that this level is indeed far below the threshold for adverse effects. The exclusions are based on the following considerations: Ñ the general provisions of the standard should not be violated. If the peak value of the mean-squared Þeld strengths and the equivalent power densities are in accordance with the provision of 4. Further, these studies have also shown that similar devices will not expose the user in excess of the exclusion criterion for the uncontrolled environment (see 4. The 20 W/kg limit for the wrists and ankles allows higher absorptions in the soft tissues produced by the induced currents speciÞed in Table 1 ßowing in these bony, narrow cross-sectional areas. In many cases, however, the determination could be made with an appropriate source material. Detailed measurements of the Þeld dis tribution over the volume of the human body and spatial averaging over the same volume could, in some instances, be used to verify compliance with the relaxation of limits for partial-body exposure. In the case of the eyes and testes, direct relaxation of power density limits is not permitted. Galambos, ÒAuditory Perception of Radio-Frequency Electromagnetic Fields,Ó Journal of the Acoustical Society of America, 71 (6), pp. Lords, ÒBehavioral and Thermal Effects of Microwave Radi ation at Resonant and Non-Resonant Wavelengths,Ó Radio Science, 12 (6S), pp. Hunt, ÒDistribution of Electromagnetic Energy Depo sition in Models of Man with Frequencies near Resonance,Ó in Biological Effects of Electromagnetic Waves (Johnson, C. Chou, ÒEffects of High Intensity Microwave Pulse Exposure of Rat Brain,Ó Radio Science, 17 (5S), pp. Christensen, ÒMicrowave-Induced Acoustic Effects in Mam malian Auditory Systems and Physical Materials,Ó Annals of the New York Academy of Sciences, 247, pp. Walsh, ÒThe Effect of Wave Impedance on Human Whole-Body Radio-frequency Absorption Rates,Ó Report No. King, ÒBehavioral Effects of Low-Level Microwave Irradiation in the Closed-Space Situation,Ó in Symposium Proceedings: Biological Effects and Health Implications of Micro wave Radiation, Report No. Herman, ÒSpatial Distribution of Microwave Oven Leaks,Ó Journal of Microwave Power, 17 (2), pp. Adams, ÒAdjustments in Metabolic Heat Production by Squirrel Monkeys Exposed to Microwaves,Ó Journal of Applied Physiology: Respiratory, Environmental, and Exercise Physiology, 50 (4), pp. Adams, ÒBehavioral Thermoregulation in the Squirrel Monkey: Adaptation Processes During Prolonged Microwave Exposure,Ó Behavioral Neuroscience, 97 (1), pp. Akel, ÒMinimal Changes in Hypothalamic Temperature Accompany Microwave-Induced Alteration of Thermoregulatory Behavior,Ó Bioelectromagnetics, 5 (1), pp. Akel, ÒTher moregulatory Consequences of Long-Term Microwave Exposure at Controlled Ambient Temperatures,Ó Bio electromagnetics, 6 (4), pp. Papadopoulos, ÒEffect of Nonionizing Radiation on the Purkinje Cells of the Uvula in Squirrel Monkey Cerebellum,Ó Bioelectromagnetics, 2 (3), pp. McCrossan, ÒMicrowave Lens Effects in Humans,Ó Archives of Ophthalmology, 88, pp, 259Ð262, 1972. Neidlinger, ÒMicrowave Lens Effects in Humans,Ó Archives of Ophthalmology, 93, pp. Lin, ÒMicrowave-Induced Changes in Nerve Cells: Effects of Modulation and Temper ature,Ó Bioelectromagnetics, 6 (3), pp. Catravas, ÒCombined Effects of Anticholinesterase Drugs and Low-Level Microwave Radiation,Ó Radiation Research, 84, pp. House, ÒInduction of Cal cium-Ion Efßux from Brain Tissue by Radio-Frequency Radiation: Effects of Modulation Frequency and Field Strength,Ó Radio Science, 14 (6S), pp. Faulk, ÒInduction of Cal cium-Ion Efßux from Brain Tissue by Radio-Frequency Radiation: Effect of Sample Number and Modula tion Frequency on the Power-Density Window,Ó Bioelectromagnetics, 1 (1), pp. Joines, ÒA Role for the Magnetic Field in the Radiation-Induced Efßux of Calcium Ions from Brain Tissue In Vitro,Ó Bioelectromagnetics, 6 (4), pp. Adair, ÒOperant Control of Convective Cooling and Microwave Irradiation by the Squirrel Monkey,Ó Bioelectromagnetics, 6 (4), pp. A Search for Frequency-SpeciÞc Athermal Biological Effects on Protein Synthesis,Ó Bioelectromagnetics, 2 (2), pp. Adey, ÒAlterations in Protein Kinase Activity Following Exposure of Cultured Human Lymphocytes to Modulated Microwave Fields,Ó Bioelectromagnetics, 5 (3), pp. Clarke, ÒFailure of Rats to Escape from a Poten tially Lethal Microwave Field,Ó Bioelectromagnetics, 1 (2), pp. Vanni, ÒThermal Haemolytic Threshold of Human Erythrocytes,Ó Journal of Microwave Power, 20 (3), pp. Guy, ÒMicrowave-Induced Auditory Responses in Guinea Pigs: Relationship of Threshold and Microwave-Pulse Duration,Ó Radio Science, 14 (6S), pp. Guy, ÒMicrowave Radiation and Heart-Beat Rate of Rabbits,Ó Journal of Microwave Power, 15 (2), pp. Cain, ÒAbsence of Heart-Rate Effects in Isolated Frog Heart Irradiated with Pulse Modulated Microwave Energy,Ó Journal of Microwave Power, 10 (4), pp. Justesen, ÒTemperature Gradients in the Microwave-Irradiated Egg: Implications for Avian Teratogenesis,Ó Journal of Microwave Power, 18 (2), pp. Liu, ÒEffects of X-Band Microwave Exposure on Rabbit Erythrocytes,Ó Bioelectromagnetics, 3 (4), pp. Garber, ÒErythrocyte Hemolysis by Radiofrequency Fields,Ó Bioelectromag netics, 6 (3), pp. Hardy, ÒCataracts and Ultra-High-Frequency Radiation,Ó American Medical Association Archives of Industrial Health, 18, pp. Amer, ÒThe Absence of Coherent Vibrations in the Raman Spectra of Living Cells,Ó Physics Letters, 98A (3), pp. Berteaud, ÒDetermination of a Thermal Equivalent of Millimeter Microwaves in Living Cells,Ó Journal of Microwave Power, 14 (4), pp. Berteaud, ÒStudies on Possible Genetic Effects of Microwaves in Pro caryotic and Eucaryotic Cells,Ó Radiation and Environmental Biophysics, 20, pp. Lampe, ÒAcute Effects of Microwave Radia tion on Experimental Animals (24 000 Megacycles),Ó Journal of Occupational Medicine, 1, pp. Landeen, ÒEffects on Dogs of Chronic Exposure to Micro wave Radiation,Ó Journal of Occupational Medicine, 5, pp. Landeen, ÒEffect of Microwave Radiation on the Hemopoietic System of the Rat,Ó Toxicology and Applied Pharmacology, 6 (1), pp. Parshad, ÒMicrowave Radiation-Induced Calcium Ion Efßux from Human Neuroblastoma Cells in Culture,Ó Bioelectromagnetics, 5 (1), pp. McRee, ÒIn Vitro Effects of Microwave Radiation on Rat Liver Mito chondria,Ó Bioelectromagnetics, 5 (1), pp. Feld, ÒAvoidance by Rats of Illumination with Low Power Nonionizing Electromag netic Energy,Ó Journal of Comparative and Physiological Psychology, 89 (2), pp. Wesler, ÒDopamine Receptors and Microwave Energy Exposure,Ó Journal of Bioelec tricity, 2 (2-3), pp.

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However arrhythmia surgery buy 80 mg valsartan free shipping, since the biosimilar medicinal product can only be authorised if it has the same safety and efficacy profile as the reference medicinal product blood pressure medication used to stop contractions buy cheap valsartan 160 mg on-line, relevant changes in treatment are not expected upon switching from the reference product to blood pressure chart by height and weight order valsartan 80mg on line a biosimilar medicinal product (or vice versa) hypertension first line treatment purchase 80mg valsartan with amex. Substitution (the passage of a specialty subject to a prescription to another specialty by the pharmacist, without consulting the doctor) is not allowed in Belgium for biologicals (including biosimilars). The registration procedure of a biosimilar medicine ensures that there are no therapeutically relevant differences between a biosimilar medicine and its reference medicine. Exceptions are a few situations where a change is directly contraindicated due to individual patient considerations. Denmark – Danish Medicines Agency (2016) Danish Medicines Agency (Laegemiddelstyrelsen) – Frequently asked questions about biological and biosimilar medicinal products Available here Summary: Is there a greater risk that patients create antibodies against biosimilar medicinal products compared with the reference medicinal product? The production of antibodies can occur when taking biological medicinal products as well as biological medicinal products. Biosimilar medicinal products are not associated with an increased risk of antibody production. The biosimilar medicinal product can only be authorised if it has the same efficacy profile as the reference medicinal product, and consequently you will not experience any changes in your treatment if you switch to a biosimilar medicinal product. However, to avoid uncontrolled exchange between biological medicines (biosimilar medicines or reference medicines), interchangeability may be considered provided the following conditions are respected: 1. A patient being treated with a biological medicine must be informed of, and agree to, the possible interchangeability between two biological medicines (reference medicine and/or biosimilar medicine). Italy – Procurement law (2016) Italy – New procurement law for biological medicines Available here (Italian only) Summary: Regional authorities are now obliged to re-open the supply agreements within 60 days after entrance of the biosimlar medicine to the market. Therapeutic continuity is allowed, even if the medicine is not ‘preferred’, but medical justification can be asked. Therapetic continuity is not allowed if the medicine did not offer to participate in the framework. Therefore biosimilar medicines are interchangeable with the respective reference originator. This consideration is valid for naïve patients and for patients already under treatment. Consequently, the choice of treatment with a drug reference biological or with a biosimilar remains a clinical decision entrusted to the specialist physician prescriber. In the context of all biological medicines, it is important that careful consideration is given by healthcare professionals to decisions of this nature. If it is planned to change the medicine a patient receives from a reference to a biosimilar medicine or vice versa, the treating physician should be involved; this should involve discussion between the prescriber/ patient, and prescriber /dispensing pharmacist. It is important to highlight that under this legislation biological medicines are specifically excluded from being added to interchangeable medicine lists. As such they cannot be subjected to pharmacy substitution as exists for small chemical molecules. New patients can be treated with a biosimilar right away; uncontrolled exchange between biological medicines (regardless of whether they are innovator products or biosimilar medicines) must be avoided. In other words, a patient must receive adequate clinical monitoring and clear instructions; and if a patient is treated with a biological medicine, detailed product and batch information must be recorded in the patient file to guarantee the traceability of the product in the event of problems. It can apply to the following situations: Switching from reference drug to biosimilar. Further clinical studies confirming safety of switching are considered unnecessary. The decision on switching products is made by the treating physician or hospital, who have to provide the necessary information to patients. To ensure traceability, adverse reactions with biological drugs should be reported with the drug name, active substance and batch number. Competition leads to price reductions that reduce the financial burden of expensive biological drugs in the healthcare system. In Norway, automatic substitution in pharmacies of biological or biosimilar products is not allowed. The Norwegian Medicines Agency has proposed that the Pharmacy Act § 6-6, which is the basis for generic (automatic) substitution in pharmacies, should be altered, eventually permitting automatic substitution of new classes of medicinal products. Poland – Minister of Health (2014) Minister of Health (MoH) – MoH position on biosimilar infliximab within the scope of the drug prescription programmes Not available Summary: the Minister of Health takes the view that any exchange within the scope of drugs containing infliximab at any level of therapy is permissible. There is sufficient evidence to consider that the switch from a reference biologic medicine of infliximab, etanercept and rituximab to the respective biosimilar medicine in patients under treatment will not cause loss of efficacy or increase of adverse effects. This evidence applies to all indications approved for the respective biosimilar medicine (the position on adalimumab will be reviewed after their availability in the Portuguese market). This ensures adequate control of the procedure, with permanent registration of medicinal products, brands, lots and the therapeutic schemes of each patient and pathology. The initiation of treatment should be carried out with the less costly biosimilar or reference biologic medicine (for the institution that makes these medicines available); a goal to be achieved in all naïve patients. When the assessment of alternative brands of the same biologic medicine translates in a significant reduction of costs (for the institution) in patients already under treatment with a biological medicinal product, a process of switch for the lowest cost medicine should be implemented. Each institution should have as objective the promotion of switch in all patients clinically stable. The process of switching from a reference biological medicinal product to a biosimilar medicine, or vice versa, musts take into consideration the following conditions: a. The switch of the medicine cannot occur in a period of treatment that is less than 6 months. All the prescribers and other technicians involved in the switching program (physicians, pharmacists and nurses) must be involved and informed about the process and their benefits. The decision to switch must be explained by the prescriber to the patient, clarifying the decision and providing all the necessary information. The process should safeguard the necessary time for the physician and patient to know the conditions of switching. Until the clarification of the reason for refusal, the medicine that the patient was already using should be available. The date of the switch, the brand and the batch of the new medicine available will then be registered. The monitoring and recording of adverse effects or other events related to the new medicine, such as the presence of signs of immunogenicity, should be maintained but do not require an additional monitoring compared with the reference biologic medicine. Therefore, the same trademark of the medicine should be maintained during the required time to its traceability. This period may be defined in the ‘Medicines National Formulary’ for different medicines, but when omitted, it should not be less than 6 months. It states that the originator biologic medicine and biosimilar are interchangeable for established patients, except if its non-interchangeability is scientifically proven. Individual patients may be switched to another biological medicine, including a biosimilar medicine, as part of a clinician led management programme which has appropriate monitoring in place. There are differing clinical characteristics within specialties which may be important to consider when using biosimilar medicines. While practice is evolving, some specialties may consider that it is most appropriate to use biosimilar medicines in new patients. Substitution should only be considered if the prescribing physician gives prior consent. The authorization of a biosimilar confirms that the differences between the biosimilar and its reference preparation do not affect safety or efficacy. However, the approval of the Institute does not state whether a biosimilar can be used interchangeably with the reference preparation. By authorising a biosimilar medicine, Swissmedic confirms that the differences between the biosimilar and its reference product do not affect its safety and efficacy. Swissmedic’s authorisation nevertheless contains no recommendation regarding whether a biosimilar can be substituted for the reference product. As a result, the prescriber can switch a patient from the reference biological medicine to its biosimilar. The decision to prescribe a biological medicine for an individual patient, whether a reference or biosimilar medicine (or to change between the two), rests with the responsible prescriber in consultation with the patient; in line with the principles of shared decision making. Evolving evidence and treatment guidance should be made available to patients and prescribers to support them in their decision-making. This should take into consideration therapeutic need and whether or not the patient is likely to adhere to treatment. If more than 1 treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose). The Committee concluded that its recommendations for infliximab could apply both to the reference product and to its biosimilars.


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