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Pre-clinical Development
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals. The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics. Companies use stylized statistics to illustrate the risks in preclinical research, such as that on average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug. Types Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamics (what the drug does to the body) (PD), pharmacokinetics (what the body does to th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process—from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials—to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food & Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of diseases i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cancer
Cancer is a group of diseases involving Cell growth#Disorders, abnormal cell growth with the potential to Invasion (cancer), invade or Metastasis, spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible Signs and symptoms of cancer, signs and symptoms include a lump, abnormal bleeding, prolonged cough, unexplained weight loss, and a change in defecation, bowel movements. While these symptoms may indicate cancer, they can also have other causes. List of cancer types, Over 100 types of cancers affect humans. Tobacco use is the cause of about 22% of cancer deaths. Another 10% are due to obesity, poor Diet (nutrition), diet, sedentary lifestyle, lack of physical activity or Alcohol abuse, excessive alcohol consumption. Other factors include certain infections, exposure to ionizing radiation, and environmental pollutants. infectious causes of cancer, Infection with specific viruses, bacteria and parasites is an environmental factor cau ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Gastric
The stomach is a muscular, hollow organ in the upper gastrointestinal tract of humans and many other animals, including several invertebrates. The Ancient Greek name for the stomach is ''gaster'' which is used as ''gastric'' in medical terms related to the stomach. The stomach has a dilated structure and functions as a vital organ in the digestive system. The stomach is involved in the gastric phase of digestion, following the cephalic phase in which the sight and smell of food and the act of chewing are stimuli. In the stomach a chemical breakdown of food takes place by means of secreted digestive enzymes and gastric acid. It also plays a role in regulating gut microbiota, influencing digestion and overall health. The stomach is located between the esophagus and the small intestine. The pyloric sphincter controls the passage of partially digested food (chyme) from the stomach into the duodenum, the first and shortest part of the small intestine, where peristalsis takes over ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Effect (medicine)
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. Adverse effects are sometimes referred to as " iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Metabolites
In biochemistry, a metabolite is an intermediate or end product of metabolism. The term is usually used for small molecules. Metabolites have various functions, including fuel, structure, signaling, stimulatory and inhibitory effects on enzymes, catalytic activity of their own (usually as a cofactor to an enzyme), defense, and interactions with other organisms (e.g. pigments, odorants, and pheromones). A primary metabolite is directly involved in normal "growth", development, and reproduction. Ethylene exemplifies a primary metabolite produced large-scale by industrial microbiology. A secondary metabolite is not directly involved in those processes, but usually has an important ecological function. Examples include antibiotics and pigments such as resins and terpenes etc. Some antibiotics use primary metabolites as precursors, such as actinomycin, which is created from the primary metabolite tryptophan. Some sugars are metabolites, such as fructose or glucose, which ar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dosage Form
Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components ( excipients), configured in a particular way (such as a capsule shell) and apportioned into a specific dose. For example, two products may both be amoxicillin, but one may come in 500 mg capsules, while another may be in 250 mg chewable tablets. The term unit dose can also refer to non-reusable packaging, particularly when each drug product is individually packaged. However, the FDA differentiates this by referring to it as ''unit-dose "packaging" or "dispensing"''. Depending on the context, ''multi(ple) unit dose'' may refer to multiple distinct drug products ''packaged'' together or a ''single'' product containing multiple drugs and/or doses. Formulations The term dosage form may also sometimes refer only to the pharmaceutical formulation of a drug product's constituent substances, witho ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Circulatory System
In vertebrates, the circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the body. It includes the cardiovascular system, or vascular system, that consists of the heart and blood vessels (from Greek meaning ''heart'', and Latin meaning ''vessels''). The circulatory system has two divisions, a systemic circulation or circuit, and a pulmonary circulation or circuit. Some sources use the terms ''cardiovascular system'' and ''vascular system'' interchangeably with ''circulatory system''. The network of blood vessels are the great vessels of the heart including large elastic arteries, and large veins; other arteries, smaller arterioles, capillaries that join with venules (small veins), and other veins. The circulatory system is closed in vertebrates, which means that the blood never leaves the network of blood vessels. Many invertebrates such as arthropods have an open circulatory system with a he ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Enzyme Activity
Enzyme assays are laboratory methods for measuring enzyme, enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibitor, enzyme inhibition. Enzyme units The quantity or concentration of an enzyme can be expressed in Mole (unit), molar amounts, as with any other chemical, or in terms of activity in enzyme units. Enzyme activity Enzyme activity is a measure of the quantity of active enzyme present and is thus dependent on various physical conditions, ''which should be specified''. It is calculated using the following formula: :\mathrm=\mathrm_\text=\mathrm\times\mathrm where :\mathrm = Enzyme activity :\mathrm_\text = Moles of substrate converted per unit time :\mathrm = Rate of the reaction :\mathrm = Reaction volume The SI unit is the katal, 1 katal = 1 mole (unit), mol s−1 (mole per second), but this is an excessively large unit. A more practical and commonly used value is enzyme unit (U) = 1 μmol min−1 (micromole per minute). 1 U correspon ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Gastrointestinal Tract
The gastrointestinal tract (GI tract, digestive tract, alimentary canal) is the tract or passageway of the Digestion, digestive system that leads from the mouth to the anus. The tract is the largest of the body's systems, after the cardiovascular system. The GI tract contains all the major organ (biology), organs of the digestive system, in humans and other animals, including the esophagus, stomach, and intestines. Food taken in through the mouth is digestion, digested to extract nutrients and absorb energy, and the waste expelled at the anus as feces. ''Gastrointestinal'' is an adjective meaning of or pertaining to the stomach and intestines. Nephrozoa, Most animals have a "through-gut" or complete digestive tract. Exceptions are more primitive ones: sponges have small pores (ostium (sponges), ostia) throughout their body for digestion and a larger dorsal pore (osculum) for excretion, comb jellies have both a ventral mouth and dorsal anal pores, while cnidarians and acoels have ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Macaque
The macaques () constitute a genus (''Macaca'') of gregarious Old World monkeys of the subfamily Cercopithecinae. The 23 species of macaques inhabit ranges throughout Asia, North Africa, and Europe (in Gibraltar). Macaques are principally frugivorous (preferring fruit), although their diet also includes seeds, leaves, flowers, and tree bark. Some species such as the long-tailed macaque (''M. fascicularis''; also called the crab-eating macaque) will supplement their diets with small amounts of meat from shellfish, insects, and small mammals. On average, a southern pig-tailed macaque (''M. nemestrina'') in Malaysia eats about 70 large rats each year. All macaque social groups are arranged around dominant matriarchs. Macaques are found in a variety of habitats throughout the Asian continent and are highly adaptable. Certain species are synanthropic, having learned to live alongside humans, but they have become problematic in urban areas in Southeast Asia and are not suitabl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Murinae
The Old World rats and mice, part of the subfamily Murinae in the family Muridae, comprise at least 519 species. Members of this subfamily are called murines. In terms of species richness, this subfamily is larger than all mammal families except the Cricetidae and Muridae, and is larger than all mammal orders except the bats and the remainder of the rodents. Description The Murinae are native to Africa, Europe, Asia, and Australia. They are terrestrial placental mammals. They have also been introduced to all continents except Antarctica, and are serious pest animals. This is particularly true in island communities where they have contributed to the endangerment and extinction of many native animals. Two prominent murine species have become vital laboratory animals: the brown rat and house mouse are both used as medical subjects. The murines have a distinctive molar pattern that involves three rows of cusps instead of two, the primitive pattern seen most frequently ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
