Three Basic Elements

Market approval or registration of a pharmaceutical product depends on the fulfilment of three main requirements  

This sounds fairly simple, but these three basic terms must be interpreted in a very wide sense every single aspect within these categories must be substantiated and proven under practical conditions. The scope and definitions change with time and with scientific, pharmaceutical and methodological progress. 

The definitions for quality, safety and efficacy vary between product groups, countries, authorities and between people within authorities. In fact, there are no exact definitions at all. There are directives, guidelines and recommendations describing what must or should be done and which data should be provided, but the application for marketing approval is judged on relative criteria. 

Quality - as far as it can be judged independently of safety and efficacy - is in principle assessed by a comparison with the state of the art, i.e. with similar products. Products with inferior quality than other products may need improvements before they can be registered, products which surpass current standards will raise the general standards. Safety and efficacy, too, are no absolute values which can be easily defined. Market approval depends on a reasonable relationship between safety and efficacy, between risks and benefits. 

Quality does not only comprise the final product itself and its attributes that can be tested. The high variability, in particular of biological products, demands that all variables of the manufacturing process are evaluated. Product quality commences with the starting materials and their attributes, runs through the entire manufacturing process and extends to the manufacturing facility and its infrastructure. 

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Here again wo see a pristine cxtimple of the three basic elements of emergence (1) the global phenomenon (in this case the cell-value density) emerges out of an... 

Epidemiologic studies of the macroenvironment focused on the diet and the long incubation period have led us to postulate that long-lasting disturbances in the normal gastric mucosa may determine the final outcome of the neoplastic transformation W. This explains the present interest in precursor lesions rather than in cancer itself. We, therefore, need to scrutinize the gastric microenvironment and attempt to point out the components that may be relevant to neoplasia. The microenvironment could be considered to be determined by three basic elements ... 

Most optimization problems involve constraints. For example, it might be necessary for a maximum temperature or maximum flowrate not to be exceeded. Thus, the general form of an optimization problem involves three basic elements ... 

It has been reported that hydrogen embrittlement is a form of stress corrosion cracking (SCC). Three basic elements are needed to induce SCC the first element is a susceptible material, the second element is environment, and the third element is stress (applied or residual). For hydrogen embrittlement to occur, the susceptible material is normally higher strength carbon or low-alloy steels, the environment must contain atomic hydrogen, and the stress can be either service stress and/or residual stress from fabrication. If any of the three elements are eliminated, HE cracking is prevented. 

Whether the prediction scheme is a simple chart, a formula, or a complex numerical procedure, there are three basic elements that must be considered meteorology, source emissions, and atmospheric chemical interactions. Despite the diversity of methodologies available for relating emissions to ambient air quality, there are two basic types of models. Those based on a fundamental description of the physics and chemistry occurring in the atmosphere are classified as a priori approaches. Such methods normally incorporate a mathematical treatment of the meteorological and chemical processes and, in addition, utilize information about the distribution of source emissions. Another class of methods involves the use of a posteriori models in which empirical relationships are deduced from laboratory or atmospheric measurements. These models are usually quite simple and typically bear a close relationship to the actual data upon which they are based. The latter feature is a basic weakness. Because the models do not explicitly quantify the causal phenomena, they cannot be reliably extrapolated beyond the bounds of the data from which they were derived. As a result, a posteriori models are not ideally suited to the task of predicting the impacts of substantial changes in emissions. 

General system theory views a system as possessing three basic elements - inputs, transforms, and outputs (see Figure 1.1). An example of a simple system is the mathematical relationship... 

Maintenance procedures should include a thorough examination of the three basic elements of a fire extinguisher ... 

Besides the three basic elements of carbon, hydrogen, and oxygen that are common to all plants, there are 16 other elements known to be essential to good plant growth. Their percentages are given below. 

Pareto Chart The Pareto principle suggests a problem (effect) can be attributed to relatively few causes. In quantitative terms, 80% of the problems come from 20% of the causes (machines, raw materials, operators, etc.) therefore effort aimed at the right 20% can solve 80% of the problems. A Pareto chart includes three basic elements (1) the causes to the total effect, ranked by the magnitude of the contribution (2) the frequency of each cause and (3) the cumulative-percent-of-total effect of... 

In its simplest terms, our model of the regulation-technological change relationship consists of three basic elements ... 

JECFA is a scientific advisory body established in tire 1950s, prior to the establishment of the CAC. Over the past 40 years, it has provided independent scientific advice to all FAO and WHO member countries. The traditional and current activities of JECFA are mainly in the area of risk assessment, not risk management. To some extent, however, JECFA activities also touch on risk management. Risk assessment, risk management, and risk communication constitute the three basic elements of risk analysis that are taken into account in the Codex procedure for setting MRLs of veterinary drug residues in foods (Table 11.1). 

Life is made of three basic elements matter, energy and information... Any element in life that is not matter and energy can be reduced to information. 

The modem process of electrodeposition can thus be described as a combination of three basic elements (a) Electrophoresis - migration of charged polymer particles to metal surface (b) Deposition - colloidal de-stabilization of particles at the metal-bath interface and (c) Insulation - formation of an adherent, non-conductive layer of resin on the metal surface. The last named element is responsible for the high throwing power which can be achieved with the electrocoating process. 

There are three basic elements to entrepreneurship in chemical production (Fig. 12.6). The first - estabhshing entrepreneurial focus - means that performance targets have to be set which are driven by the capital markets in a participative process starting from the top - that is, at the business unit or divisional level -and which follow through a transparent value-driver tree in order to determine targets for the front line (see Section 12.2.1). The desired end product is a balanced scorecard for each operational unit with a clear Hnk to the overall profitability of the business unit... 

Fig. 12.6 Three basic elements of entrepreneurship Source McKinsey...

As photoelectrons are strongly absorbed by matter, this technique requires operating under a vacuum or even an ultra high vacuum (10 to 10 torr). Typical instruments have three basic elements (Fig. 5.4) ... 

The examination is conducted to test three basic elements of science teaching, namely, scientific skills, scientific attitude (scientific temper) and understanding of scientific concepts and principles. 

Regardless of which method is used, all geometry minimizations are comprised of three basic elements. First, energy and derivatives are computed at the initial geometry. Second, the geometry is changed to take a step toward the minimum. Third, a test (or series of tests) is carried out to determine if the new position is close enough to the PES minimum. If it is, the minimization is complete. If not, the process is repeated to take another step toward the minimum. 

Gas chromatography is a method by which gas or vaporizable liquid mixtures are physically separated into their individual components and quantified. There are three basic elements in any industrial gas chromatograph ... 

We say that the grounds support the claim on the basis of the existence of a warrant that explains the connection between the grounds and the claim. It is easy to relate the structure of these basic elements with the process of inference, whether inductive or deductive, in classical logic. The warrants are the set of rules of inference, and the grounds and claim are the set of well-defined propositions or statements. It will be only the sequence and procedures, as used to formulate the three basic elements and their structure in a logical fashion, that will determine the type of inference that is used. 

One way to handle this complexity is to apply a system view to services, as proposed by several authors (e.g., Lovelock 1995 Ringman-Brundage 1995). Systems are made up of elements bearing attributes and the relationships between those elements. Elements may be (sub)systems themselves. If the elements of a service system are defined as those different components that have to be designed and managed, then the most elementary system model for services is made up of three basic elements ... 

EPA risk assessment framework and establish a common approach with its paradigm. The U.S. EPA s overall ecological risk assessment process is illustrated in Fig. 1. It consists of three basic elements Problem Formulation, Analysis, and Risk Characterization. 

The three basic elements of the RAPyD-400 — the vacuum system, the inlet system, and the quadrupole analyzer — can be seen in Figure 3.5. The quadrupole analyzer, which itself consists of two separate parts, lies inside the main vacuum chamber. The high vacuum is attained using a turbomolecular pump, which is backed by a dual-stage rotary pump mounted externally to the main system. The sample inlet system is connected to the ion source of the mass spectrometer via a heated molecular beam tube. Around the underside of the ion source is a copper cold finger, which is cooled by liquid nitrogen and used as a sample dump to prevent carryover from one sample to another. 

There are three basic elements to improving the safety of a medication process ... 

The construction documents consist of three basic elements ... 

What other critical information can you gather fi-om the accident list above Remember, your accident prevention program is a system. And in order for your system to be effective, it must contain three basic elements ... 

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