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European Directorate For The Quality Of Medicines
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the ''Convention on the Elaboration of a European Pharmacopoeia'' (an international treaty adopted by the Council of Europe in 1964: ETS 50, Protocol). The signatories to the convention, – 39 member states and the European Union (EU) as of March 2020 – are committed to the harmonisation of quality standards for safe medicines throughout the European continent and beyond. In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which is recognised as a scientific benchmark worldwide and is legally binding in member states. The EU pharmaceutical legislation refers directly to the Ph. Eur. and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Council Of Europe
The Council of Europe (CoE; french: Conseil de l'Europe, ) is an international organisation founded in the wake of World War II to uphold European Convention on Human Rights, human rights, democracy and the Law in Europe, rule of law in Europe. Founded in 1949, it has 46 member states, with a population of approximately 675 million; it operates with an annual budget of approximately 500 million euros. The organisation is distinct from the European Union (EU), although it is sometimes confused with it, partly because the EU has adopted the original Flag of Europe, European flag, created for the Council of Europe in 1955, as well as the Anthem of Europe, European anthem. No country has ever joined the EU without first belonging to the Council of Europe. The Council of Europe is an official United Nations General Assembly observers, United Nations Observer. Being an international organization, the Council of Europe cannot make laws, but it does have the ability to push for the enf ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Reference Standard
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products. Pharmacopoeial reference standards Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where pharmacopoeial tests or assays call for the use of a pharmacopoeial reference standard, only those results obtained using the specified pharmacopoeial reference standard are conclusive. See also *Standard (metrology) *Pharmacopoeia A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Marketing Authorisation Application
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market. MAA is part of the official procedure before the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the Committee for Medicinal Products for Human Use of the European Medicines Agency, a specialised agency of the European Commission. In the United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ..., the equivalent process is called New Drug Application. References {{reflist Drug safety ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Monograph
A monograph is a specialist work of writing (in contrast to reference works) or exhibition on a single subject or an aspect of a subject, often by a single author or artist, and usually on a scholarly subject. In library cataloging, ''monograph'' has a broader meaning—that of a nonserial publication complete in one volume (book) or a definite number of volumes. Thus it differs from a serial or periodical publication such as a magazine, academic journal, or newspaper. In this context only, books such as novels are considered monographs.__FORCETOC__ Academia The English term "monograph" is derived from modern Latin "monographia", which has its root in Greek. In the English word, "mono-" means "single" and "-graph" means "something written". Unlike a textbook, which surveys the state of knowledge in a field, the main purpose of a monograph is to present primary research and original scholarship ascertaining reliable credibility to the required recipient. This research is prese ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Monographs
A monograph is a specialist work of writing (in contrast to reference works) or exhibition on a single subject or an aspect of a subject, often by a single author or artist, and usually on a scholarly subject. In library cataloging, ''monograph'' has a broader meaning—that of a nonserial publication complete in one volume (book) or a definite number of volumes. Thus it differs from a serial or periodical publication such as a magazine, academic journal, or newspaper. In this context only, books such as novels are considered monographs.__FORCETOC__ Academia The English term "monograph" is derived from modern Latin "monographia", which has its root in Greek. In the English word, "mono-" means "single" and "-graph" means "something written". Unlike a textbook, which surveys the state of knowledge in a field, the main purpose of a monograph is to present primary research and original scholarship ascertaining reliable credibility to the required recipient. This research is prese ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Injection (medicine)
An injection (often and usually referred to as a "shot" in US English, a "jab" in UK English, or a "jag" in Scottish English and Scots) is the act of administering a liquid, especially a drug, into a person's body using a needle (usually a hypodermic needle) and a syringe. An injection is considered a form of parenteral drug administration; it does not involve absorption in the digestive tract. This allows the medication to be absorbed more rapidly and avoid the first pass effect. There are many types of injection, which are generally named after the body tissue the injection is administered into. This includes common injections such as subcutaneous, intramuscular, and intravenous injections, as well as less common injections such as intraperitoneal, intraosseous, intracardiac, intraarticular, and intracavernous injections. Injections are among the most common health care procedures, with at least 16 billion administered in developing and transitional countries each yea ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Capsule (pharmacy)
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are: * Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by ''e.g.'' processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”. * Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil. Both of these classes of capsules are made from aqueous solutions of gelling agents, such as animal protein (mainly gelatin) or plant polysaccharides or their derivatives (such as carrageenans and modified forms of starch and cellulose). Other ingredients can be added to the gelling agent solution including plast ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tablet (pharmacy)
A tablet (also known as a pill) is a pharmaceutical oral dosage form (''oral solid dosage'', or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose. Tablets are prepared either by molding or by compression. The excipients can include diluents, binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually attractive or aid in visual identification of an unknown tablet. A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release rate of the active ingredient, to make it more resistant to the environment (extending its shelf li ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dosage Forms
Dosage forms (also called unit doses) are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (such as a capsule shell, for example), and apportioned into a particular dose. For example, two products may both be amoxicillin, but one is in 500 mg capsules and another is in 250 mg chewable tablets. The term unit dose can also sometimes encompass non-reusable ''packaging'' as well (especially when each drug product is individually packaged), although the FDA distinguishes that by ''unit-dose "packaging" or "dispensing"''. Depending on the context, ''multi(ple) unit dose'' can refer to distinct drug products ''packaged'' together, or to a ''single'' drug product containing multiple drugs and/or doses. The term dosage form can also sometimes refer ''only'' to the pharmaceutical formulation of a drug product's constituent drug substance(s) and any ble ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Herbals
A herbal is a book containing the names and descriptions of plants, usually with information on their medicinal, tonic, culinary, toxic, hallucinatory, aromatic, or magical powers, and the legends associated with them.Arber, p. 14. A herbal may also classify the plants it describes, may give recipes for herbal extracts, tinctures, or potions, and sometimes include mineral and animal medicaments in addition to those obtained from plants. Herbals were often illustrated to assist plant identification.Anderson, p. 2. Herbals were among the first literature produced in Ancient Egypt, China, India, and Europe as the medical wisdom of the day accumulated by herbalists, apothecaries and physicians. Herbals were also among the first books to be printed in both China and Europe. In Western Europe herbals flourished for two centuries following the introduction of moveable type (c. 1470–1670). In the late 17th century, the rise of modern chemistry, toxicology and pharmacology reduced ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Excipients
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as "bulking agents", "fillers", or "diluents"), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility. Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerns such as by facilitating powder flowability or non-stick properties, in addition to aiding ''in vitro'' stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors. A comprehensive classification system based on structure- ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Active Ingredients
An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. The similar terms active pharmaceutical ingredient (also abbreviated as API) and bulk active are also used in medicine, and the term active substance may be used for natural products. Some medication products may contain more than one active ingredient. The traditional word for the active pharmaceutical agent is pharmacon or pharmakon (from el, φάρμακον, adapted from '' pharmacos'') which originally denoted a magical substance or drug. The terms active constituent or active principle are often chosen when referring to the active substance of interest in a plant (such as salicylic acid in willow bark or arecoline in areca nuts), because the word "ingredient" in many minds connotes a sense of human agency (that is, something t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
