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First-in-human Trial
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over severa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
What Are Clinical Trial Phases
What or WHAT may refer to: * What, an interrogative pronoun and adverb * "What?", one of the Five Ws used in journalism Film and television * ''What!'' (film) or ''The Whip and the Body'', a 1963 Italian film directed by Mario Bava * '' What?'' (film), a 1972 film directed by Roman Polanski * "What", the name of the second baseman in Abbott and Costello's comedy routine "Who's on First?" * "What?", the catchphrase of professional wrestler Stone Cold Steve Austin Music * ''what.'', a comedy/music album by Bo Burnham, 2013 * What Records, a UK record label * What? Records, a US record label Songs * "What" (song), by Melinda Marx, 1965 * "What?" (Rob Zombie song), 2009 * "What?" (SB19 song), 2021 * "What?", by 666 from ''The Soft Boys'' * "What", by Bassnectar from ''Vava Voom'' * "What?", by Corrosion of Conformity from '' Eye for an Eye'' * "What?", by the Move from ''Looking On'' * "What?", by A Tribe Called Quest from ''The Low-End Theory'' Science and technology * Web ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Post Marketing Surveillance
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions. Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between he ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Selection Bias
Selection bias is the bias introduced by the selection of individuals, groups, or data for analysis in such a way that proper randomization is not achieved, thereby failing to ensure that the sample obtained is representative of the population intended to be analyzed. It is sometimes referred to as the selection effect. The phrase "selection bias" most often refers to the distortion of a statistical analysis, resulting from the method of collecting samples. If the selection bias is not taken into account, then some conclusions of the study may be false. Types Sampling bias Sampling bias is systematic error due to a non-random sample of a population, causing some members of the population to be less likely to be included than others, resulting in a biased sample, defined as a statistical sample of a population (or non-human factors) in which all participants are not equally balanced or objectively represented. It is mostly classified as a subtype of selection bias, sometimes sp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Gender-neutral Language
Gender-neutral language or gender-inclusive language is language that avoids bias towards a particular sex or gender. In English, this includes use of nouns that are not gender-specific to refer to roles or professions, formation of phrases in a coequal manner, and discontinuing the blanket use of male or female terms. For example, the words ''policeman'' and ''stewardess'' are gender-specific job titles; the corresponding gender-neutral terms are ''police officer'' and ''flight attendant''. Other gender-specific terms, such as ''actor'' and ''actress'', may be replaced by the originally male term; for example, ''actor'' used regardless of gender. Some terms, such as ''chairman'', that contain the component ''-man'' but have traditionally been used to refer to persons regardless of sex are now seen by some as gender-specific. An example of forming phrases in a coequal manner would be using ''husband and wife'' instead of ''man and wife''. Examples of discontinuing the blanket use of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacokinetics
Pharmacokinetics (from Ancient Greek ''pharmakon'' "drug" and ''kinetikos'' "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism. The substances of interest include any chemical xenobiotic such as: pharmaceutical drugs, pesticides, food additives, cosmetics, etc. It attempts to analyze chemical metabolism and to discover the fate of a chemical from the moment that it is administered up to the point at which it is completely eliminated from the body. Pharmacokinetics is the study of how an organism affects a drug, whereas pharmacodynamics (PD) is the study of how the drug affects the organism. Both together influence dosing, benefit, and adverse effects, as seen in PK/PD models. Overview Pharmacokinetics describes how the body affects a specific xenobiotic/chemical after administration through the mechanisms of absorption and distribution, as ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Contrast Medium
A contrast agent (or contrast medium) is a substance used to increase the contrast of structures or fluids within the body in medical imaging. Contrast agents absorb or alter external electromagnetism or ultrasound, which is different from radiopharmaceuticals, which emit radiation themselves. In x-rays, contrast agents enhance the radiodensity in a target tissue or structure. In MRIs, contrast agents shorten (or in some instances increase) the relaxation times of nuclei within body tissues in order to alter the contrast in the image. Contrast agents are commonly used to improve the visibility of blood vessels and the gastrointestinal tract. Several types of contrast agent are in use in medical imaging and they can roughly be classified based on the imaging modalities where they are used. Most common contrast agents work based on X-ray attenuation and magnetic resonance signal enhancement. Radiocontrast media For radiography, which is based on X-rays, iodine and barium are the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Microdosing
Microdosing, or micro-dosing, is a technique for studying the behaviour of drugs in humans through the administration of doses so low ("sub-therapeutic") they are unlikely to produce whole-body effects, but high enough to allow the cellular response to be studied. This is called a "Phase 0 study" and is usually conducted before clinical Phase I to predict whether a drug is viable for the next phase of testing. Human microdosing aims to reduce the resources spent on non-viable drugs and the amount of testing done on animals. Less commonly, the term "microdosing" is also sometimes used to refer to precise dispensing of small amounts of a drug substance (e.g., a powder API) for a drug product (e.g., a capsule) and, when the drug substance also happens to be liquid, this can potentially overlap what is termed microdispensing. For example, cannabis microdosing and psychedelic microdosing. Techniques The basic approach is to label a candidate drug using the radio isotope carbon-14 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, 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 drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but 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 d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration (United States)
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), but 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 such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying fro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Animal Testing
Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This approach can be contrasted with field studies in which animals are observed in their natural environments or habitats. Experimental research with animals is usually conducted in universities, medical schools, pharmaceutical companies, defense establishments, and commercial facilities that provide animal-testing services to the industry. The focus of animal testing varies on a continuum from pure research, focusing on developing fundamental knowledge of an organism, to applied research, which may focus on answering some questions of great practical importance, such as finding a cure for a disease. Examples of applied research include testing disease treatments, breeding, defense research, and toxicology, including cosmetics testing. In edu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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