Approval rates

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The introduction of biologies as credible therapies is evidenced by the increase in the approval rate of biologies over the last two decades. This is in contrast to the decline in the introduction of new small molecules (Fig. 1). The market potential of biologies is also projected to grow exponentially over the next few years (Fig. 2). These are some of the many drivers for... 

There are proposals to reduce the time it takes to approve or authorize a new drug from approximately 18 months to 9, significantly less than FDA s approval rate [112]. As a result, more companies could shift research and development (R D) efforts to Europe R D investments have doubled in Europe in the past 10 years, while the increase has been fivefold in the United States [113]. 

It is forecast that up to the end of the current decade, the research focus regarding therapeutic mAbs will be on two categories oncology and arthritis, and inflammatory and immune disorders. A significant increase of sales is expected up to 2008 for chimeric mAbs, in absolute terms, and for human and humanized mAbs, in relative terms (Figure 16.2). Up to now, murine mAbs are those with the lowest approval rate (4.5%), whereas the chimeric are the most successful (26%). The approval rates for humanized mAbs (18%) and human antibodies (14%) were intermediate. However, as most of the last two types are still under development, the approval situation may change significantly in the future (Reichert and Pavlou, 2004). 

However, it is recognized that, despite all these efforts, the approval of new chemical entities (NCEs) has stagnated and reached an historical low in 2002 with 17 new molecule entities approved by the US Food and Drug Administration (US FDA) the approval rates only increased marginally the following year as 21 new entities were... 

Scott and White hospital in Texas is an example of a pharmacy-run women s health clinic. In this model, the obstetrics-gynecology physician or nurse identifies patients at risk for mood disorders, including premenstrual syndrome and premenstrual dysphoric disorder, and refers them to the pharmacist for further evaluation, treatment, and drug therapy monitoring. Patient approval ratings were 96% excellent. 

Success Rates—The estimated probability of reaching each clinical phase was based on survey responses. These data are both available and likely to have been reported accurately by survey respondents. Both studies predicted final approval rates not from the study sample, but from a large sample of NCEs in the CSDD database. DiMasi estimated the ultimate approval rate—23 percent—for the population of survey firm NCEs in the CSDD database that met the survey inclusion criteria. Hansen s estimated approval rate—12.5 percent—was based on all NCEs in the CSDD database covering the years of his study. 24... 

Reasons for the apparent decline in approval rates for drugs the FDA rated as having the highest therapeutic potential are not clear. Sponsoring firms may be submitting less complete or lower quality NDAs over time, or the FDA s expectations may have increased. It is also possible that increases in the FDA s responsibilities and the greater constraints on its resources... 

Despite this disturbing trend, drugs designated by the FDA as category A are still associated with higher approval rates than others. 

Low approval rates of new chemical entities by national and international drug administrations and an increasing awareness and measurability of potential side effects of marketed drugs suggest that scaffold hopping and bioisosteric... 

Program reviews by external experts include regional and national accreditations, institutional reviews, and certification or approval ratings from engineering professional associations. For example, in Sweden, programs are reviewed by the Swedish National Agency for Higher Education. A description of a recent review is found in Box 9.3 in a later section of this chapter. 

Source Adapted with permission of The Chlorine Institute, Inc. The Chlorine Institute does not approve, rate, certify, or endorse any gasket used in chlorine service. Users should refer to test results (obtained from ga et manufacturer or... 

The Land Acquisition Act of 1894 empowered state governments to acquire land for any public purpose project. It provides three methods for arriving at the value of land, which were (i) government approved rates, (ii) capitalized value of average annual income from the land, and (iii) prevalent market rate based on the land transactions data. The process of land acquisition under this Act is illustrated in Fig. 34.4. As the figure shows, much depended on the District Collector s satisfaction. 

These leadership gauges can also be used in industry. During the normal course of employment, team members are expected to perform work tasks that they might find less than desirable. Appointed leaders like FLSs do not have to depend on approval ratings or popularity contests they have a job to perform. If this is the case, it does not really matter what the FLS does because The FLS is always right and will always be right. ... 

Start-up is an activity that requires Operations to safely produce a quality product at a pre-approved rate of production. During this procedure the SIS devices were checked to ensure they were functioning properly and were capable of performing their safety function as established during Run-in. Once this was satisfactorily completed, results were documented, and Operations approval was finalized. Validation of this SIS project was complete. 

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