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Azvudine
Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. It was discovered for the treatment of Hepatitis C and has since been investigated for use against other viral diseases such as AIDS and COVID-19, for which it was granted conditional approval in China. Azvudine was first discovered in 2007.Chang J, Bao X, Wang Q, Guo X, Wang W, Qi XPreparation of 2′-fluoro-4′-substituted nucleoside analogs as antiviral agents.20070807. Chinese Patent Application No: CN 2007-10137548. Chinese Patent No: CN 101177442A, 20080514. It costs 350 Chinese yuan per 7 days for COVID, . Medical uses In July 2021, azvudine became conditionally approved in China for the following indication: "to treat high-viral-load cases of HIV-1, in combination with a nucleoside reverse-transcriptase inhibitor and a non-nucleoside reverse-transcriptase inhibitor". The approval text describes it as a dual reverse transcriptase and Vif inhibitor. In July 2022, azvudine received emergen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Reverse Transcriptase Inhibitor
Reverse-transcriptase inhibitors (RTIs) are a class of antiretroviral drugs used to treat HIV infection or AIDS, and in some cases hepatitis B. RTIs inhibit activity of reverse transcriptase, a viral DNA polymerase that is required for replication of HIV and other retroviruses. Mechanism of action When HIV infects a cell, reverse transcriptase copies the viral single stranded RNA genome into a double-stranded viral DNA. The viral DNA is then integrated into the host chromosomal DNA, which then allows host cellular processes, such as transcription and translation, to reproduce the virus. RTIs block reverse transcriptase's enzymatic function and prevent completion of synthesis of the double-stranded viral DNA, thus preventing HIV from multiplying. A similar process occurs with other types of viruses. The hepatitis B virus, for example, carries its genetic material in the form of DNA, and employs an RNA-dependent DNA polymerase to replicate. Some of the same compounds used as RTIs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CYP3A
Cytochrome P450, family 3, subfamily A, also known as CYP3A, is a human gene locus. A homologous locus is found in mice. The CYP3A locus includes all the known members of the 3A subfamily of the cytochrome P450 superfamily of genes. These genes encode monooxygenases which catalyze many reactions involved in drug metabolism and synthesis of cholesterol, steroids and other lipids. The CYP3A cluster consists of four genes: * CYP3A4, * CYP3A5, * CYP3A7, and * CYP3A43. The region also contains four pseudogene Pseudogenes are nonfunctional segments of DNA that resemble functional genes. Most arise as superfluous copies of functional genes, either directly by DNA duplication or indirectly by reverse transcription of an mRNA transcript. Pseudogenes are ...s: * , * , * , and * . as well as several extra exons which may or may not be included in transcripts produced from this region. Previously another CYP3A member, CYP3A3, was thought to exist; however, it is now thought that ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medication Package Insert
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the drug or give the drug to another person, such as a minor. Inserts for over-the-counter medications are also written plainly. In the United States, labelling for the healthcare practitioner is called "Prescribing Information" (PI), and labelling for patients and/or caregivers includes "Medication Guides", "Patient Package Inserts", and "Instructions for Use". In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information le ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
First-in-class Medication
A first-in-class medication is a pharmaceutical that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category. Although many first-in-class medications qualify as breakthrough therapies, Regenerative Medicine Advanced Therapies and/or orphan drugs, first-in-class status itself has no regulatory effect. Examples Controversy Safety By definition, a first-in-class drug does not have the safety evidence from analogous products that not-first-in-class drugs would have. However, a study investigating recalls and warnings in relation to first-in-class drugs approved between 1997 and 2012 by Health Canada has found that first-in-class drugs actually have a more favourable benefit-to-harm ratio. Economics First-in-class drugs are often seen as commerci ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Medical Products Administration
The National Medical Products Administration (NMPA, , formerly the China Food and Drug Administration, or CFDA) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the former regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency. In 2018, as part of China's 2018 government administration overhaul, the name was changed to 'National Medical Products Administration' and merged into the newly created State Administration for Market Regulation. The headquarters are in Xicheng District, Beijing. In its first incarnation as the CFDA, the NMPA replaced a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States, streamlining regulation processes for food and drug safety. The National Medical Products Administration is directly under the State Council of the People's Republic of China, which is in charge of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Reverse Transcriptase
A reverse transcriptase (RT) is an enzyme used to generate complementary DNA (cDNA) from an RNA template, a process termed reverse transcription. Reverse transcriptases are used by viruses such as HIV and hepatitis B to replicate their genomes, by retrotransposon mobile genetic elements to proliferate within the host genome, and by eukaryotic cells to extend the telomeres at the ends of their linear chromosomes. Contrary to a widely held belief, the process does not violate the flows of genetic information as described by the classical central dogma, as transfers of information from RNA to DNA are explicitly held possible. Retroviral RT has three sequential biochemical activities: RNA-dependent DNA polymerase activity, ribonuclease H (RNase H), and DNA-dependent DNA polymerase activity. Collectively, these activities enable the enzyme to convert single-stranded RNA into double-stranded cDNA. In retroviruses and retrotransposons, this cDNA can then integrate into the host geno ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Zhengzhou University
Zhengzhou University (), colloquially known in Chinese as Zhèngdà () and abbreviated as ZZU is a public university located in Zhengzhou, Henan, China. Zhengzhou University is the largest university in China in terms of number of students (around 73,000 students). The Campus size is the tenth largest in PR China with . Zhengzhou University was co-constructed by the Chinese Ministry of Education and the Government of Henan Province under the initiative of "One Province, One University". It has been recognized for receipt of huge development spending given its potential to become a reputed seat of higher learning. ZZU was included in "Project 211" by the Chinese Ministry of Education which aimed at transforming promising universities into "Key National Universities". The "Project 211" was later on replaced with a more ambitious and comprehensive initiative of tertiary education " Double First-Class University Plan" with an intent to develop elite Chinese universities and their dis ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Body Mass
Human body weight is a person's mass or weight. Strictly speaking, body weight is the measurement of weight without items located on the person. Practically though, body weight may be measured with clothes on, but without shoes or heavy accessories such as mobile phones and wallets, and using manual or digital weighing scales. Excess or reduced body weight is regarded as an indicator of determining a person's health, with body volume measurement providing an extra dimension by calculating the distribution of body weight. Average adult human weight varies by continent, from about in Asia and Africa to about in North America, with men on average weighing more than women. Estimation in children There are a number of methods to estimate weight in children for circumstances (such as emergencies) when actual weight cannot be measured. Most involve a parent or health care provider guessing the child's weight through weight-estimation formulas. These formulas base their findings ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
No-observed-adverse-effect Level
The no-observed-adverse-effect level (NOAEL) denotes the level of exposure of an organism, found by experiment or observation, at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects of the tested protocol. In drug development, the NOAEL of a new drug is assessed in laboratory animals, such as mice, prior to initiation of human trials in order to establish a safe clinical starting dose in humans. The OECD publishes guidelines for Preclinical Safety Assessments, in order to help scientists discover the NOAEL. Synopsis Some adverse effects in the exposed population when compared to its appropriate control might include alteration of morphology, functional capacity, growth, development or life span. The NOAEL is determined or proposed by qualified personnel, often a pharmacologist or a toxicologist. The NOAEL could be defined as "the highest experimental point that is without adverse effect," meaning that under ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Boxed Warning
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Elevated Liver Enzymes
In medicine, the presence of elevated transaminases, commonly the transaminases alanine transaminase (ALT) and aspartate transaminase (AST), may be an indicator of liver dysfunction. Other terms include transaminasemia, transaminitis, and elevated liver enzymes (though they are not the only enzymes in the liver). Normal ranges for both ALT and AST vary by gender, age, and geography and are roughly 8-40 U/L (0.14-0.67 μkal/L). Mild transaminesemia refers to levels up to 250 U/L. Drug-induced increases such as that found with the use of anti-tuberculosis agents such as isoniazid are limited typically to below 100 U/L for either ALT or AST. Muscle sources of the enzymes, such as intense exercise, are unrelated to liver function and can markedly increase AST and ALT. Cirrhosis of the liver or fulminant liver failure secondary to hepatitis commonly reach values for both ALT and AST in the >1000 U/L range. Elevated transaminases that persist less than six months are termed "acute" in na ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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