Compliance factor

Specimen compliance factor C/dC/d ( j Stress concentration factor ... 

Besides these three basic mechanisms, which are central to the field of ethnopsychopharmacology, there are also nonbiological elements that can influence the way in which individuals respond to medications. These elements are compliance factors, placebo effects, stress, social support, personality styles, and physician prescribing patterns (Karlow 1992). 

Culture also plays a major role. For instance, physician bias, placebo effects, compliance factors, and patient beliefs and expectations all can influence the clinical effects of psychotropic agents (Smith et al. 1993). It has been reported that because of psychiatric practitioner bias, severe psychiatric illnesses are often diagnosed in African American patients, who are then prescribed high doses of neuroleptics (Price et al. 1985). It has also been reported that Caucasians tend to be more responsive than non-Caucasians to placebo (Escobar and Tuason 1980). 

Allocation on the basis of historical emissions was intensively discussed. Here, it was requested that above all the companies, branches and political powers from East Germany focus on the very early base periods, since considerable emissions reductions had been achieved in East Germany, particularly during the 1990s. By contrast, an allocation based on the most recent base periods was requested by the companies and branches that were not able to refer to emissions reductions in good time, primarily so as not to make the ratio between the free allocation and historic emissions (the so-called compliance factor) too ambitious. 

The serious conflicts of interest in the process of the NAP preparation, as well as the multitude of practical restrictions (data availability, pressure of time), led to a simple procedure for the basic model of allocation for the existing installations it proved to be the smallest common denominator. Regarding the allocation of allowances on the basis of historical emissions for the period 2000-2002 without further sectoral differentiation, a very simple base model was created. Here, allocation arose out of the historical emissions for this period multiplied by a so-called compliance factor. This simple model was expanded, however, by a multitude of special rules which had significant consequences for the compliance factor and considerably eroded the uniformity and transparency of the allocation model. 

Following very intensive tests, discussions and political disputes about models that were in part extremely complex, a comparatively simple but also undifferentiated early action rule was implemented. The allocation for those emission quantities of the base period 2000-2002, for which the early action facts are taken into account, takes place for a time period of twelve years following the conclusion of the measure with a compliance factor of one. The allocation precisely corresponds to the emissions in the base period of 2000-2002. Accordingly, the following emissions are acknowledged ... 

In the sum, a volume of 182 Mt CO2 fell under special regulations, for which allocation only ensued from historical CO2 emissions, and a compliance factor orientated towards the reduction of CO2 was applied. The total emissions reduction established in the NAP budget had to be produced by installations which represented only about 64% of the CO2 emissions covered by emissions trading. 

In the allocation procedure, a special allocation for the electricity production from CHP plants was catered for in order to compensate incentives to reduce the electricity production from CHP. The construction of this regulation comprises a special allocation for the historical production of electricity by CHP, which is subjected to an expost adjustment. If electricity production from CHP is reduced in the course of the period, the return of the special allocation for CHP is requested in the ratio of five times the special allocation for a reduction of 1 million kWh electricity production from CHP. After the special allocation for the electricity production from CHP had borne 35 EUA per million kilowatt-hours in the first draft of the NAP, this special allocation was reduced to 27 EUA as a result of political negotiations, and also in order not to make the compliance factor too ambitious. Annually, 2.02 million EUA were additionally allocated to the CHP plants. 

Concerning the terms of the transfer rule and the provisions for additional new plants, the procedure had been specified until the end of the second trading period. The transfer provision should, for plants put into operation within the period 2005-2007, also be applied to the trading period of 2008-2012. The benchmark version for additional new plants should be valid until the end of 2012, without applying a compliance factor. 

The NAP also shows significant changes in the version of the cabinet resolution (BReg 2004c). Here, the transfer rule is limited to a period of four years. Thereafter, the allocation is planned for another fourteen years on the basis of the annual average CO2 emissions in the reference period valid for the respective trading period, without considering a compliance factor. 

For the additional new entrants, the allocation based on production data and the new entrants benchmark should be applied for a period of fourteen years, without considering a compliance factor. The allocation should still be subject to an ex-post adjustment to the lower as well as to the higher levels. 

Uniform compliance factor (CF)C 0.971 As laid down in Allocation Act... 

The German NAP therefore uses the so-called proportionate allocation cuts procedure. If the total sum of the allowances allocated to individual installations (except cases of hardship) is higher than 495 (499 million EUA minus new entrants reserve minus allowances for hardship clauses), the allocations for all the plants are correspondingly reduced, if the allocation does not have the compliance factor one. 

Figure 4.2. Effective compliance factor considering special provisions and the cap adjustment according to 4(4) ZuG 2007.

As a result, the intentionally planned uniform compliance factor was 0.971.2... 

The compliance factor in the original BMU proposal from January 2004 amounted to 0.927. The difference from the uniform compliance factor of 0.971 is mainly a result of an inflation of the cap, the reduction of the new entrants set-aside and the special allocation to CHP. 

It became clear, however, that such an approach could only be partially implemented within the political process. Ultimately, the effective compliance factor, i.e. the relation between the allocated allowances and the historical emissions of the base period, played the central role in all of the negotiations. In order to meet the maximum fulfilment factor of 0.97, which constituted the political target, special allocation rules were modified on the one hand (e.g. a reduction of the special allocation for CHP), and the new entrants reserve was reduced on the other hand. Furthermore, the aggregated emission cap for the pilot phase 2005-2007 was increased. Nevertheless, contrary to the stated political objective, the underestimation of the effects of the flexibilisa-tion option finally led, to rise up to a 0.926 of the effective compliance factor for the affected plants. 

However, there are other major factors in determining the dosing regimen, such as the nature of the concentration-response relationship for both efficacy and toxicity (therapeutic window) and commercial/ compliance factors. There are additional reasons why caution should be applied in assuming an efficacy-time profile from a given plasma concentration-time profile. Some reasons why the time course of drug concentration and effect may differ are given in Table 5.1. 

Pharmaceutical plants need to address maintenance and reliability issues better in order to produce life critical products, on time, on cost, and on quality, safely with respect for personnel, property, and the environment. Also, there are issues of evidence of service and other FDA, OSHA, and EPA compliance factors that impact the maintenance function in pharmaceutical plants. These issues are discussed in other chapters within this book. 

The first two terms on the right-hand side of equation [12.6] are viscoelastic terms proposed by Schapery, where e represents uniaxial kinematic (or total) strain at time t, o is the Cauchy stress at time t, is the instantaneous compliance and AD(r[i ) is a transient creep compliance function. The factor g defines stress and temperature effects on the instantaneous elastic compliance and is a measure of state dependent reduction (or increase) in stiffness. Transient compliance factor gi has a similar meaning, operating on the creep compliance component. The factor gj accounts for the influence of loading rate on creep. The function i ) represents a reduced timescale parameter defined by ... 

If < value of the acceptable risk, then the compliance factor for risk is 0. 

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