New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is important in disease. However, little is known about the safety, toxicity, pharmacokinetics, and metabolism of this NCE in humans. It is the function of drug development to assess all of these parameters prior to human clinical trials. A further major objective of drug development is to recommend the dose and schedule for the first use in a human clinical trial ("first-in-man" [FIM] or First Human Dose [FHD]).
In addition, drug development must establish the physicochemical properties of the NCE: its chemical makeup, stability, and solubility. Manufacturers must optimize the process they use to make the chemical so they can scale up from a medicinal chemist producing milligrams, to manufacturing on the kilogram and ton scale. They further examine the product for suitability to package as capsules, tablets, aerosol, intramuscular inject able, subcutaneous inject able, or intravenous formulations. Together, these processes are known in preclinical development as chemistry, manufacturing, and control (CMC).
Many aspects of drug development focus on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in humans. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the heart and lungs, brain, kidney, liver and digestive system), as well as effects on other parts of the body that might be affected by the drug (e.g., the skin if the new drug is to be delivered through the skin). Increasingly, these tests are made using in vitro methods (e.g., with isolated cells), but many tests can only be made by using experimental animals to demonstrate the complex interplay of metabolism and drug exposure on toxicity.
The information is gathered from this pre-clinical testing, as well as information on CMC, and submitted to regulatory authorities (in the US, to the FDA), as an Investigational New Drug application or IND.
Nanotechnologies Nanotechnology is a relatively new field of science that makes more headlines every year. It is a field that focuses on the small--the extremely small. In nanotechnology, people manipulate atoms and molecules to make new things. Those things can be materials or devices. Throughout history, people have made new things from altering or combining substances that already exist. But nanotechnology works the opposite way. In nanotechnology, researchers develop a substance from the small to the large by manipulating the basic building blocks of matter. The result could be miniature materials or devices that have completely unique properties.
Science of the small The basic building blocks of nanotechnologies are atoms and molecules. All substances are made up of molecules. A drop of water, for example, is made up of millions of water molecules. If you were to keep dividing the drop into smaller droplets, you would end up with one molecule. That one water molecule would have the same properties as the drop of water.
Molecules are made of atoms held together by chemical bonds. The water molecule consists of two hydrogen atoms and an oxygen atom. Diamonds are made up of a molecule of carbon atoms bonded together. Salt is made of the sodium chloride molecule, which is one sodium atom bonded to one chloride atom. Atoms and molecules are so small that a new prefix was coined to measure them: nano. The prefix "nano" comes from the Greek word for dwarf. Nano represents one billionth and so one nanometer is one-billionth of a meter. That's about the size of one strand of the width of your hair split into about 50,000 pieces! It's also about the size of ten hydrogen atoms. Things on the nano scale are generally between 1 and 100 nanometers. Proteins in our bodies, viruses, and some particles in the air are nano sized.
Nanotechnology is not about simply making devices smaller. The field uses the fact that nano size materials can have different properties than their larger counterparts. Color, hardness, melting point, and conductivity are all some of the properties that can change as the material become nano sized. One physical characteristic that can lead to these changes is the increased ratio of the surface area to volume. Surface area is all the area that is on the outside--surface--of the material. Volume is the amount of three-dimensional space taken up by a material. As a material shrinks, its surface area increases compared to its volume, In the nano size, this ratio can increase dramatically, which can lead to different reactions. Gold nano particles, for example, can appear a reddish color and turn liquid at room temperature. It is the arrangement of the atoms and molecules that gives materials its properties. Diamonds and the lead of pencils (graphite) are both made of up carbon molecules. In diamonds, the arrangement and bonds of the carbon atoms make it hard and clear. Graphite is dark and relatively soft. If researchers can pluck individual atoms and decide how to arrange them, they can determine the property of the material. One nano scale material that was discovered in 1991 is also made of pure carbon. Carbon nano tubes are threads of carbon and the arrangement of its carbon makes it light, flexible, and stronger than steel.
A nano-world of technologies There are high hopes that research in nanotechnology will translate into many products and devices that will help people. The technology will affect a wide range of fields, including transportation, sports, electronics, and medicine. Some of the current and future possibilities of nanotechnology includes:
- Medicine: Researchers are working to develop nanorobots to help diagnose and treat health problems. Medical nanorobots, also called nanobots, could someday be injected into a person bloodstream. In theory, the nanobots would find and destroy harmful substances, deliver medicines, and repair damage.
- Sports: Nanotechnology has been incorporated in outdoor fabrics to add insulation from the cold without adding bulk. In sports equipment, nanotech metals in golf clubs make the clubs stronger yet lighter, allowing for greater speed. Tennis balls coated with nanoparticles protect the ball from air, allowing it to bounce far longer than the typical tennis ball.
- Materials Science: Nanotechnology has led to coatings that make fabric stain proof and paper water resistant. A car bumper developed with nanotechnology is lighter yet a lot harder to dent than conventional bumpers. And nanoparticles added to surfaces and paints could someday make them resistant to bacteria or prevent dirt from sticking.
- Electronics: The field of nano-electronics is working on miniaturizing and increasing the power of computer parts. If researchers could build wires or computer processing chips out of molecules, it could dramatically shrink the size of many electronics.
Biotechnologies What is Biotechnology?
At its simplest, biotechnology is technology based on biology - biotechnology harnesses cellular and bimolecular processes to develop technologies and products that help improve our lives and the health of our planet. We have used the biological processes of microorganisms for more than 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products. Modern biotechnology provides breakthrough products and technologies to combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, and use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes. Currently, there are more than 250 biotechnology health care products and vaccines available to patients, many for previously untreatable diseases. More than 13.3 million farmers around the world use agricultural biotechnology to increase yields, prevent damage from insects and pests and reduce farming's impact on the environment. And more than 50 biorefineries are being built across North America to test and refine technologies to produce biofuels and chemicals from renewable biomass, which can help reduce greenhouse gas emissions. Recent advances in biotechnology are helping us prepare for and meet society’s most pressing challenges. Here's how:
Biotech is helping to heal the world by harnessing nature's own toolbox and using our own genetic makeup to heal and guide lines of research by:
Reducing rates of infectious disease;
Saving millions of children's lives;
Changing the odds of serious, life-threatening conditions affecting millions around the world;
Tailoring treatments to individuals to minimize health risks and side effects;
Creating more precise tools for disease detection; and
Combating serious illnesses and everyday threats confronting the developing world.
Fuel The World
Biotech uses biological processes such as fermentation and harnesses biocatalysts such as enzymes, yeast, and other microbes to become microscopic manufacturing plants. Biotech is helping to fuel the world by:
Streamlining the steps in chemical manufacturing processes by 80% or more;
Lowering the temperature for cleaning clothes and potentially saving $4.1 billion annually;
Improving manufacturing process efficiency to save 50% or more on operating costs;
Reducing use of and reliance on petrochemicals;
Using biofuels to cut greenhouse gas emissions by 52% or more;
Decreasing water usage and waste generation; and
Tapping into the full potential of traditional biomass waste products.
Feed The World
Biotech improves crop insect resistance, enhances crop herbicide tolerance and facilitates the use of more environmentally sustainable farming practices. Biotech is helping to feed the world by:
Generating higher crop yields with fewer inputs;
Lowering volumes of agricultural chemicals required by crops-limiting the run-off of these products into the environment;
Using biotech crops that need fewer applications of pesticides and that allow farmers to reduce tilling farmland;
Developing crops with enhanced nutrition profiles that solve vitamin and nutrient deficiencies;
Producing foods free of allergens and toxins such as myco toxin; and
Improving food and crop oil content to help improve cardiovascular health.
Person and his health
Genetics of the person Introduction to genetics:
Genetics is probably one of the most exciting lessons in biology.
At the same time, it can be a bit confusing because sometimes it is difficult to imagine what the bare eyes cannot see. We will try to make things very simple and easy for you.
What is genetics?
Genetics is the science of studying how living things pass on characteristics (or traits) and its variations in their cell make-up from one generation to the other.
Simply, it is the study of how living things inherit features like eye-colour, nose shape, height and even behavior from their parents.
A scientist who studies genetics is called a geneticist.
Genetics is the study of genes, genetic variation, and heredity in living organisms. It is generally considered a field of biology, but it intersects frequently with many of the life sciences and is strongly linked with the study of information systems.
The father of genetics is Gregory Mendel, a late 19th-century scientist and Augustinianfriar. Mendel studied 'trait inheritance', patterns in the way traits were handed down from parents to offspring. He observed that organisms (pea plants) inherit traits by way of discrete "units of inheritance". This term, still used today, is a somewhat ambiguous definition of what is referred to as a gene.
Trait inheritance and molecular inheritance mechanisms of genes are still primary principles of genetics in the 21st century, but modern genetics has expanded beyond inheritance to studying the function and behavior of genes. Gene structure and function, variation, and distribution are studied within the context of the cell, the organism (e.g. dominance) and within the context of a population. Genetics has given rise to a number of sub-fields including epigenetic and population genetics. Organisms studied within the broad field span the domain of life, including bacteria, plants, animals, and humans.
Genetic processes work in combination with an organism's environment and experiences to influence development and behavior, often referred to as nature versus nurture. The intra- or extra-cellular environment of a cell or organism may switch gene transcription on or off. A classic example is two seeds of genetically identical corn, one placed in a temperate climate and one in an arid climate. While the average height of the two corn stalks may be genetically determined to be equal, the one in the arid climate only grows to half the height of the one in the temperate climate due to lack of water and nutrients in its environment.
Quality assurance and food safety to human health The Importance of Quality Assurance and Food Safety in Modern Food Production Systems
The liberalization of the global trade, and the fact that the consumers in the industrialized countries are more and more demanding food to be not only economical, but also healthy, tasty, safe and sound in respect to animal welfare and the environment, are changing so far quantity-oriented food production, guaranteeing the nutrient supply for a nation, into an international quality-oriented food market, where commodities, production areas, production chains and brands compete each other. The competitiveness of food production will soon be more dependent on the reliability of the safety and the quality of the food and acceptability of the production procedures than on quantity and price. In contrast to the quantity-oriented markets that are often subsidized and producers can always sell everything they produce, quality-oriented markets are market-driven. Thus, apart from the steady increase of the national and international standards for food safety and public health, there is a growing influence of the consumer's demands (often completely ignorant of agriculture) on the animal production, its allied industries, advisers, consultants and food animal veterinarians. All of this means that the agricultural supply of food production is facing remarkable changes in the years to come, which is both challenge and opportunity for food animal producers, packing plants and meat processors as well as for the veterinary profession.
In countries that have implemented a consistent mandatory meat inspection, this classical harvest food safety procedure and the more and more stringent rules for post-harvest food safety measures improving the hygiene standards during slaughter, meat processing, storage and distribution have led to a remarkable decline of meat related food-borne diseases in man. However, although meat inspection and food hygiene have been regarded as sufficient to guarantee safe meat over almost 100 years, new approaches to food safety and meat quality are becoming necessary.
The majority of the real and perceived reasons for the increased concerns with the safety and quality of meat apply to the pre-harvest area of the food production chain. Furthermore, it is true that the harvest food safety measures (inspection and removing carcasses unfit for human consumption from the food chain) is assuring the consumer's protection, but they do not prevent the major safety-related defects in the slaughter pig, i.e. they are only quality control at the end of the on-farm production phase. Industries with long experiences in growing competition initially used quality control to cope with increasing quality standards. The needs to produce and sell high quality products and increase the efficiency of the production process, however, have led to the development of quality assurance systems along production chains.
Quality control is the evaluation of a final product prior to its marketing, i.e. it is based on quality checks at the end of a production chain aiming at assigning the final product to quality categories such as "high quality", "regular quality", "low quality" and "non-marketable". Since, at the end of the production chain, there is no way to correct production failures or upgrade the quality of the final product, the low-quality products can only be sold at lower prices and the non-marketable products have to be discarded. Their production costs, however, had been as high as those of the high and regular quality products. Thus, quality control has only a limited potential to increase the quality and efficiency of a multi-step production procedure. Quality Assurance, in contrast to quality control, is the implementation of quality checks and procedures to immediately correct any failure and mistake that is able to reduce the quality of the interim products at every production step.
Technique on service of health of the person Environmental health is targeted towards preventing disease and creating health-supportive environments. It includes the aspects of human health that are determined by physical, chemical, biological and social factors in the environment. Environmental health also works to assess and control these factors.
For several decades the computer technology made tremendous breakthrough in the development! And nobody is surprised by house computers. And cell phones are not luxury, but need. Let's talk about influence of the modern technique on health of the person, especially on the child's organism. Knowledge will help not only correctly and efficiently use achievements of science, but also to keep health. And first of all today we are interested in a question about health of our children.
Avoid harmful influence of inventions of the modern society how to teach them to be guided in variety appearing progress products. For this purpose it is necessary to be fully equipped, to know pluses and minuses of the modern technique.
It is known for all, that the child’s staying at the computer is harmful for his/her health. However, not all parents know how the computer influences on the child. There are four major harmful factors: load of vision, the constrained pose, load of mentality and radiation.
The invention of the mobile phone became one of the gifts of scientific and technical progress. Today scientists consider it as the most potent mass irritant since the invention of the TV. Are mobile phones so dangerous for our health or not? The British physicians claim that mobile phones accelerate reactions of a brain and if we abuse conversation by the mobile phone, it is possible to get a brain cancer.
Person and environment
Interaction of the person with the nature
Man's influence on nature. Man is not only a dweller in nature, he also transforms it. From the very beginning of his existence, and with increasing intensity human society has adapted environing nature and made all kinds of incursions into it. An enormous amount of human labour has been spent on transforming nature. Humanity converts nature's wealth into the means of the cultural, historical life of society. Man has subdued and disciplined electricity and compelled it to serve the interests of society. Not only has man transferred various species of plants and animals to different climatic conditions; he has also changed the shape and climate of his habitation and transformed plants and animals. If we were to strip the geographical environment of the properties created by the labour of many generations, contemporary society would be unable to exist in such primeval conditions.
Man is constantly aware of the influence of nature in the form of the air he breathes, the water he drinks, the food he eats, and the flow of energy and information. And many of his troubles are a response to the natural processes and changes in the weather, intensified irradiation of cosmic energy, and the magnetic storms that rage around the earth. In short, we are connected with nature by "blood" ties and we cannot live outside nature. During their temporary departures from Earth spacemen take with them a bit of the biosphere. Nowhere does nature affect humanity in exactly the same way. Its influence varies. Depending on where human beings happen to be on the earth's surface, it assigns them varying quantities of light, warmth, water, precipitation, flora and fauna. Human history offers any number of examples of how environmental conditions and the relief of our planet have promoted or retarded human development.
At any given moment a person comes under the influence of both subterranean processes and the cosmic environment. In a very subtle way he reflects in himself, in his functions the slightest oscillations occurring in nature. Electromagnetic radiations alone from the sun and stars may be broken down into a large number of categories, which are distinguishable from one another by their wavelength, the quantity of energy they emit, their power of penetration, and the good or harm they may do us. During the periods of peak solar activity we observe a deterioration in the health of people suffering from high blood pressure, arteriosclerosis or infarction of the myocardium. Disturbances occur in the nervous system and the blood vessels are more liable to suffer from spasms. At such times the number of road accidents increases, and so on. It has been noted that there is a dependence between any weakening in the Earth's magnetic field and acceleration of growth, and vice versa, growth is retarded when the magnetic field becomes stronger. The corpuscular, radioactive irradiations, cosmic dust, and gas molecules which fill all universal space are also powerful creators and regulators of human existence in biological life. The universe is in a state of dynamic balance and is constantly receiving various forms of energy. Some forms are on the increase or decrease, while others experience periodic fluctuations. Each of us is a sensitive resonator, a kind of echo of the energy flows of the universe. So it would be quite wrong to regard only the energy of the sun as the source of life on earth and humanity as its highest manifestation. The energy of distant cosmic bodies, such as the stars and the nebulae, have a tremendous influence on the life of man as an organism. For this reason our organisms adjust their existence and development to these flows of external energy. The human organism has developed receptors that utilise this energy or protect themselves from it, if it is harmful. It may be said, if we think of human beings as a high-grade biological substance, that they are accumulators of intense energy drives of the whole universe. We are only a response to the vibrations of the elemental forces of outer space, which bring us into unity with their oscillations. Every beat of the organic pulse of our existence is coordinated with the pulse of the cosmic heart. Cosmic rhythms exert a substantial influence on the energy processes in the human organism, which also has its own rhythmic beat.
Man and nature interact dialectically in such a way that, as society develops, man tends to become less dependent on nature directly, while indirectly his dependence grows. This is understandable. While he is getting to know more and more about nature, and on this basis transforming it, man's power over nature progressively increases, but in the same process, man comes into more and more extensive and profound contact with nature, bringing into the sphere of his activity growing quantities of matter, energy and information.
Humans interact with their environments in many ways: they may manipulate natural environments for economic purposes and change their surroundings using culture and technology.Human and environmental interaction generally falls into three categories, which include adaptation, dependability and modification. The problem of clean water Drinking water, also known as potable water or improved drinking of water, is water safe enough for drinking and food preparation. Globally, in 2012, 89% of people had access to water suitable for drinking. Nearly 4 billion had access to tap water while another 2.3 billion had access to wells or public taps. 1.8 billion people still use an unsafe drinking water source which may be contaminated by feces. This can result in infectious diarrhea such as cholera and typhoid among others.
Water is essential for life. The amount of drinking water required is variable. It depends on physical activity, age, health issues, and environmental conditions. It is estimated that the average American drinks about one liter of water a day with 95% drinking less than three liters per day. For those working in a hot climate, up to 16 liters a day may be required.Water makes up about 60% of weight in men and 55% of weight in women. Infants are about 70% to 80% water while the elderly are around 45%.
Typically in developed countries, tap water meets drinking water quality standards, even though only a small proportion is actually consumed or used in food preparation. Other typical uses include washing, toilets, and irrigation. Grey water may also be used for toilets or irrigation. Its use for irrigation however may be associated with risks. Water may also be unacceptable due to levels of toxins or suspended solids. Reduction of waterborne diseases and development of safe water resources is a major public health goal in developing countries. Bottled water is sold for public consumption in most parts of the world. The word potable came into English from the Late Latinpotabilis, meaning drinkable.