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Human Challenge Study
A human challenge study, also called a challenge trial or controlled human infection model (CHIM), is a type of clinical trial for a vaccine or other pharmaceutical involving the intentional exposure of the test subject to the condition tested. Human challenge studies may be ethically controversial because they involve exposing test subjects to dangers beyond those posed by potential side effects of the substance being tested. During the mid 20th and 21st century, the number of human challenge studies has been increasing. A challenge study to test promising vaccines for prevention of COVID-19 was under consideration during 2020 by several vaccine developers, including the World Health Organization (WHO), and was approved in the UK in 2021. Over the second half of the 20th and the 21st centuries, vaccines for some 15 major pathogens have been fast-tracked in human challenge studies – involving about 30,000 participants – while contributing toward vaccine development to prevent ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Immune Response
An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which could cause serious problems to the health of the host organism if not cleared from the body. There are two distinct aspects of the immune response, the innate and the adaptive, which work together to protect against pathogens. The innate branch—the body's first reaction to an invader—is known to be a non-specific and quick response to any sort of pathogen. Components of the innate immune response include physical barriers like the skin and mucous membranes, immune cells such as neutrophils, macrophages, and monocytes, and soluble factors including cytokines and complement. On the other hand, the adaptive branch is the body's immune response which is catered against specific antigens and thus, it takes longer to activate the components involv ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
COVID-19 Vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. In January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by March 2020, the global pharmaceutical industry announced a major commitment to address COVID19. In 2020, the first COVID19 vaccines were developed and made available to the public through emergency authorizations and conditional approvals. Initially, most COVID19 vaccines were two ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adjuvant
In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesic adjuvant in pain management * Immunologic adjuvant In immunology, an adjuvant is a substance that increases or modulates the immune response to a vaccine. The word "adjuvant" comes from the Latin word ''adiuvare'', meaning to help or aid. "An immunologic adjuvant is defined as any substance that ... in vaccines This is a specialized usage of a word (derived from the Latin verb "adjuvare", ''to help''), which also has a more general meaning as someone or something assisting in any operation or effect. {{sia Adjuvants ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Toxicology
Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants. The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage, duration of exposure (whether it is acute or chronic), route of exposure, species, age, sex, and environment. Toxicologists are experts on poisons and poisoning. There is a movement for evidence-based toxicology as part of the larger movement towards evidence-based practices. Toxicology is currently contributing to the field of cancer research, since some toxins can be used as drugs for killing tumor cells. One prime example of this is ribosome-inactivating proteins, tested in the treatment of leukemia. The word ''toxicology'' () is a neocla ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Laboratory Practice
Good clinical laboratory practice (GCLP) is a GxP guideline for laboratory samples from clinical studies. Good clinical practice (GCP) does not define requirements for laboratories and good laboratory practice (GLP) focusses on pre-clinical analyses and not on human samples from clinical trials. The Research Quality Association (RQA) suggested in 2003 a guideline to close the gap. Later the World Health Organization and the British Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ... issued their own versions of a GCLP guideline. Literature * WHO Good Clinical Laboratory Practice (GCLP) * Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biomarker
In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. as cited in Biomarkers are used in many scientific fields. Medicine Biomarkers used in the medical field, are a part of a relatively new clinical toolset categorized by their clinical applications. The three main classes are molecular biomarkers, cellular biomarkers or imaging biomarkers. All three types of biomarkers have a clinical role in narrowing or guiding treatment decisions and follow a sub-categorization of being either predictive, prognostic, or diagnostic. Predictive Predictive molecular, cellular, or imaging biomarkers that pass validation can serve as a method of predicting clinical outcomes. Predictive biomarkers are used to help optimize id ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cohort Study
A cohort study is a particular form of longitudinal study that samples a cohort (a group of people who share a defining characteristic, typically those who experienced a common event in a selected period, such as birth or graduation), performing a cross-section at intervals through time. It is a type of panel study where the individuals in the panel share a common characteristic. Cohort studies represent one of the fundamental designs of epidemiology which are used in research in the fields of medicine, pharmacy, nursing, psychology, social science, and in any field reliant on 'difficult to reach' answers that are based on evidence (statistics). In medicine for instance, while clinical trials are used primarily for assessing the safety of newly developed pharmaceuticals before they are approved for sale, epidemiological analysis on how risk factors affect the incidence of diseases is often used to identify the causes of diseases in the first place, and to help provide pre-clinica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dengue Fever
Dengue fever is a mosquito-borne tropical disease caused by the dengue virus. Symptoms typically begin three to fourteen days after infection. These may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic skin itching and skin rash. Recovery generally takes two to seven days. In a small proportion of cases, the disease develops into a more severe dengue hemorrhagic fever, resulting in bleeding, low levels of blood platelets and blood plasma leakage, or into dengue shock syndrome, where dangerously low blood pressure occurs. Dengue is spread by several species of female mosquitoes of the ''Aedes'' genus, principally ''Aedes aegypti''. The virus has five serotypes; infection with one type usually gives lifelong immunity to that type, but only short-term immunity to the others. Subsequent infection with a different type increases the risk of severe complications. A number of tests are available to confirm the diagnosis including detecti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pertussis
Whooping cough, also known as pertussis or the 100-day cough, is a highly contagious bacterial disease. Initial symptoms are usually similar to those of the common cold with a runny nose, fever, and mild cough, but these are followed by two or three months of severe coughing fits. Following a fit of coughing, a high-pitched whoop sound or gasp may occur as the person breathes in. The violent coughing may last for 10 or more weeks, hence the phrase "100-day cough". A person may cough so hard that they vomit, break ribs, or become very tired from the effort. Children less than one year old may have little or no cough and instead have periods where they cannot breathe. The time between infection and the onset of symptoms is usually seven to ten days. Disease may occur in those who have been vaccinated, but symptoms are typically milder. Pertussis is caused by the bacterium ''Bordetella pertussis''. It is spread easily through the coughs and sneezes of an infected person. Peopl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Shigella
''Shigella'' is a genus of bacteria that is Gram-negative, facultative anaerobic, non-spore-forming, nonmotile, rod-shaped, and genetically closely related to ''E. coli''. The genus is named after Kiyoshi Shiga, who first discovered it in 1897. The causative agent of human shigellosis, ''Shigella'' causes disease in primates, but not in other mammals. It is only naturally found in humans and gorillas. During infection, it typically causes dysentery. ''Shigella'' is one of the leading bacterial causes of diarrhea worldwide, causing an estimated 80–165 million cases. The number of deaths it causes each year is estimated at between 74,000 and 600,000. It is one of the top four pathogens that cause moderate-to-severe diarrhea in African and South Asian children. Classification ''Shigella'' species are classified by three serogroups and one serotype: * Serogroup ''A'': '' S. dysenteriae'' (15 serotypes) * Serogroup ''B'': '' S. flexneri'' (9 serotypes) * Serogroup ''C'': '' S. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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