Market evaluation, controlled

EMEA. EMEA s mission is to contribute to the protection and promotion of public and animal health by providing high-quality evaluation of medicinal products. Its goal is to develop a single European marketing authorization controlling the safety of medicines for humans and animals. 

The Health Products Agency was created under Law No. 93-5 of 4 January 1993 in relation to the safety of blood transfusion products cind medicinal products (Article L 567-1 to L 567-13 of CSP). This law was intended to put in place a system of evaluation, control and inspection for medicines and make laboratories guarantee the safety of these products under the best conditions. It also envisaged the participation in the development of a large European medicines market. 

The activated sludge process for domestic wastewater treatment was introduced to the world in 1914.1 Since then, many studies have been conducted to improve the oxygen transfer efficiency. Among the aeration devices introduced have been a porous diffuser, a filter type diffuser, a mechanical aeration device, an orifice type diffuser and a fine-pore air diffuser. The aeration market is in a substantial state of flux in the USA today. Emphasis on high efficiency has led many intensive research programmes to aim at the evaluation of the design, operation and control processes to improve overall system performance. 

Because the number of data points is low, many of the statistical techniques that are today being discussed in the literature caimot be used. While this is true for the vast majority of control work that is being done in industrial labs, where acceptability and ruggedness of an evaluation scheme are major concerns, this need not be so in R D situations or exploratory or optimization work, where statisticians could well be involved. For products going to clinical trials or the market, the liability question automatically enforces the tried-and-true sort of solution that can at least be made palatable to lawyers on account of the reams of precedents, even if they do not understand the math involved. 

Often there is a desire to compare responses to multiple treatments rather than simply evaluate active against a placebo control. For instance, it may be useful to evaluate several doses or to assess a product against another marketed product. Increasing the number of treatments will increase the sample size required overall, but will also increase the number of subjects required per treatment arm because the number of statistical comparisons is larger. If all between-group comparisons are to be made, the number of statistical tests increases dramatically as the number of treatment arms increases. With two groups, only one comparison is possible. With three groups, the number... 

The preparation of a new drug substance or dosage form for evaluation in clinical trials must meet the same regulatory requirements and controls as a marketed product. The cGMP requirements for clinical trial products are outlined by FDA and are discussed in Chapter 20. 

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

These selection and evaluation criteria were applied systematically to four technological fields, three of which contribute to new energy-efficient solutions. Passive houses, for example, with their major components of insulation solutions, window systems, ventilation and control techniques are close to market diffusion within the next ten years. Fuel cells for mobile uses in vehicles, however, are still a long way from market introduction, for instance, because of unresolved problems regarding the deactivation of the membrane electrode assembly (MEA) and the need for cost reductions by about one order of magnitude. Other types of fuel cells for stationary uses may be closer to market introduction, owing to less severe technical bottlenecks and better economic competitiveness. 

The microorganism was classified as a new species of actinomycete. Streptomyces avermitilis. Its anthelmintic activity was shown to reside in 8 closely related macrocyclic lactones, named avermectins, which were also found to possess activity against free-living and parasitic arthropods. One of the natural components, avermectin is now being evaluated as a pesticide for the control of mites of citrus and cotton crops and control of the Red Imported Fire Ant. A chemical derivative, 22,23-dihydroavermectin or ivermectin, has been developed as an antiparasitic agent. It is being marketed for use in cattle, horses and sheep and is expected to become available for swine and dogs. 

The debate about quality of evidence most frequently ranks large randomised controlled trials as the gold standard, at least for efficacy, with controlled observational studies in the middle, and imcontrolled studies and opinions at the bottom. The evaluation of therapeutic benefit and risk is, in fact, never ending because clinicians will subject marketed medicines to comparison with other existing or new medicines, and they will experiment with alternative dosage schedules and combined use with other treatments. 

---