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37-695: Serono develops and markets pharmaceuticals in the fields of reproductive health , multiple sclerosis , growth & metabolism and dermatology . The eight biotechnology products are available in four core therapeutic areas: neurology for the treatment of relapsing forms of multiple sclerosis , reproductive health for treatments of infertility , dermatology , where Serono has launched biologics in Europe for moderate-to-severe psoriasis , and growth and metabolism for treatments for HIV-associated wasting and growth deficiencies. The company also conducts research in oncology and autoimmune diseases . Through

74-486: A common molecular mechanism of action modulate the activity of a specific biological target . The definition of a mechanism of action also includes the type of activity at that biological target. For receptors, these activities include agonist , antagonist , inverse agonist , or modulator . Enzyme target mechanisms include activator or inhibitor . Ion channel modulators include opener or blocker . The following are specific examples of drug classes whose definition

111-435: A critical role, often then selling the rights to larger companies that have the resources to run the clinical trials. Drug discovery is different from Drug Development. Drug Discovery is often considered the process of identifying new medicine. At the same time, Drug development is delivering a new drug molecule into clinical practice. In its broad definition, this encompasses all steps from the basic research process of finding

148-575: A group of 2245 elderly Americans (average age of 71) surveyed over the period 2010 – 2011, those percentages were 88%, 38%, and 64%. One of the key classifications is between traditional small molecule drugs; usually derived from chemical synthesis and biological medical products ; which include recombinant proteins , vaccines , blood products used therapeutically (such as IVIG ), gene therapy , and cell therapy (for instance, stem cell therapies). Pharmaceuticals or drugs or medicines are classified into various other groups besides their origin on

185-475: A hierarchy. For example, fibrates are a chemical class of drugs (amphipathic carboxylic acids) that share the same mechanism of action ( PPAR agonist ), the same mode of action (reducing blood triglyceride levels), and are used to prevent and treat the same disease ( atherosclerosis ). However, not all PPAR agonists are fibrates, not all triglyceride-lowering agents are PPAR agonists, and not all drugs used to treat atherosclerosis lower triglycerides. A drug class

222-505: A list of essential medicines . A sampling of classes of medicine includes: Pharmaceuticals may also be described as "specialty", independent of other classifications, which is an ill-defined class of drugs that might be difficult to administer, require special handling during administration, require patient monitoring during and immediately after administration, have particular regulatory requirements restricting their use, and are generally expensive relative to other drugs. Drugs affecting

259-718: A pharmacist dispenses only on the order of a physician, physician assistant , or qualified nurse ) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis , and biopharmaceuticals , which include recombinant proteins , vaccines , blood products used therapeutically (such as IVIG ), gene therapy , monoclonal antibodies and cell therapy (for instance, stem cell therapies). Other ways to classify medicines are by mode of action, route of administration , biological system affected, or therapeutic effects . An elaborate and widely used classification system

296-452: A process known as reverse pharmacology . Hits from these screens are then tested in cells and then in animals for efficacy . Even more recently, scientists have been able to understand the shape of biological molecules at the atomic level and to use that knowledge to design (see drug design ) drug candidates. Modern drug discovery involves the identification of screening hits, medicinal chemistry , and optimization of those hits to increase

333-411: A process of identifying a new medicine. Development: Chemicals extracted from natural products are used to make pills, capsules, or syrups for oral use. Injections for direct infusion into the blood drops for eyes or ears. Preclinical research : Drugs go under laboratory or animal testing, to ensure that they can be used on Humans. Clinical testing: The drug is used on people to confirm that it

370-499: A suitable molecular target to supporting the drug's commercial launch. Drug development is the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery . It includes pre-clinical research (microorganisms/animals) and clinical trials (on humans) and may include the step of obtaining regulatory approval to market the drug. Drug Development Process Discovery: The Drug Development process starts with Discovery,

407-598: A vein , or by drops put into the ear or eye . A medication that does not contain an active ingredient and is used in research studies is called a placebo . In Europe, the term is "medicinal product", and it is defined by EU law as: In the US, a "drug" is: Drug use among elderly Americans has been studied; in a group of 2,377 people with an average age of 71 surveyed between 2005 and 2006, 84% took at least one prescription drug, 44% took at least one over-the-counter (OTC) drug, and 52% took at least one dietary supplement ; in

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444-406: Is a drug used to diagnose , cure , treat, or prevent disease. Drug therapy ( pharmacotherapy ) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in many ways. One of the key divisions is by level of control , which distinguishes prescription drugs (those that

481-504: Is a medicine or a chemical compound used to treat or cure illness. According to Encyclopædia Britannica , medication is "a substance used in treating a disease or relieving pain ". As defined by the National Cancer Institute , dosage forms of medication can include tablets , capsules , liquids, creams , and patches. Medications can be administered in different ways, such as by mouth , by infusion into

518-410: Is based on a specific mechanism of action: This type of categorisation of drugs is from a biological perspective and categorises them by the anatomical or functional change they induce. Drug classes that are defined by common modes of action (i.e. the functional or anatomical change they induce) include: This type of categorisation of drugs is from a medical perspective and categorises them by

555-548: Is called Merck Serono . Its headquarters was in Geneva, within the new Serono facilities. The US operations remain near Boston and was renamed here EMD Serono due to trademark issues with Merck & Co./MSD . The process of merging started in January 2007 after various business regulatory reviews and phases were complete. Until that time, Serono and Merck KGaA operated as separate entities. The new, combined entity, Merck Serono

592-485: Is safe to use. FDA Review: drug is sent to FDA before launching the drug into the market. FDA post-Market Review: The drug is reviewed and monitored by FDA for the safety once it is available to the public. The regulation of drugs varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions, they are regulated at

629-523: Is still a lengthy, "expensive, difficult, and inefficient process" with a low rate of new therapeutic discovery. In 2010, the research and development cost of each new molecular entity (NME) was approximately US$ 1.8 billion. Drug discovery is done by pharmaceutical companies, sometimes with research assistance from universities. The "final product" of drug discovery is a patent on the potential drug. The drug requires very expensive Phase I, II, and III clinical trials, and most of them fail. Small companies have

666-798: Is the Anatomical Therapeutic Chemical Classification System . The World Health Organization keeps a list of essential medicines . Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies , academic scientists, and governments. As a result of this complex path from discovery to commercialization, partnering has become a standard practice for advancing drug candidates through development pipelines. Governments generally regulate what drugs can be marketed, how drugs are marketed , and in some jurisdictions, drug pricing . Controversies have arisen over drug pricing and disposal of used Medicine . Medication

703-533: Is the size of other large biotechs. In 2011, a decision was made to close the Geneva headquarters and move the headquarters to Darmstadt, Germany resulting in job losses to most of the employees in Geneva. Serono operated in 44 countries, with manufacturing facilities in eight countries and sales in over 90 countries. Main manufacturing sites were in Switzerland, Italy, Spain and France; a fifth facility in Israel

740-527: Is thus composed by one element ("anti-inflammatory") that designates the mechanism of action, and one element ("nonsteroidal") that separates it from other drugs with that same mechanism of action. Similarly, one might argue that the class of disease-modifying anti-rheumatic drugs (DMARD) is composed by one element ("disease-modifying") that albeit vaguely designates a mechanism of action, and one element ("anti-rheumatic drug") that indicates its therapeutic use. Other systems of drug classification exist, for example

777-493: Is typically defined by a prototype drug , the most important, and typically the first developed drug within the class, used as a reference for comparison. This type of categorisation of drugs is from a chemical perspective and categorises them by their chemical structure. Examples of drug classes that are based on chemical structures include: This type of categorisation is from a pharmacological perspective and categorises them by their biological target. Drug classes that share

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814-406: Is used for euthanasia and physician-assisted suicide . Euthanasia is not permitted by law in many countries, and consequently, medicines will not be licensed for this use in those countries. A single drug may contain single or multiple active ingredients . The administration is the process by which a patient takes medicine. There are three major categories of drug administration: enteral (via

851-469: Is used per day (e.g., four times a day). It may include event-related information (e.g., 1 hour before meals, in the morning, at bedtime), or complimentary to an interval, although equivalent expressions may have different implications (e.g., every 8 hours versus 3 times a day). In the fields of medicine, biotechnology , and pharmacology , drug discovery is the process by which new drugs are discovered. Historically, drugs were discovered by identifying

888-723: Is usually some degree of restriction on the availability of certain therapeutic goods depending on their risk to consumers. Drug class A drug class is a group of medications and other compounds that share similar chemical structures , act through the same mechanism of action (i.e., binding to the same biological target ), have similar modes of action , and/or are used to treat similar diseases. The FDA has long worked to classify and license new medications. Its Drug Evaluation and Research Center categorizes these medications based on both their chemical and therapeutic classes. In several major drug classification systems, these four types of classifications are organized into

925-506: The affinity , selectivity (to reduce the potential of side effects), efficacy/ potency , metabolic stability (to increase the half-life ), and oral bioavailability . Once a compound that fulfills all of these requirements has been identified, it will begin the process of drug development prior to clinical trials . One or more of these steps may, but not necessarily, involve computer-aided drug design . Despite advances in technology and understanding of biological systems, drug discovery

962-3535: The central nervous system include psychedelics , hypnotics , anaesthetics , antipsychotics , eugeroics , antidepressants (including tricyclic antidepressants , monoamine oxidase inhibitors , lithium salts , and selective serotonin reuptake inhibitors (SSRIs)), antiemetics , anticonvulsants /antiepileptics, anxiolytics , barbiturates , movement disorder (e.g., Parkinson's disease ) drugs, nootropics , stimulants (including amphetamines ), benzodiazepines , cyclopyrrolones , dopamine antagonists , antihistamines , cholinergics , anticholinergics , emetics , cannabinoids , and 5-HT (serotonin) antagonists . The main classes of painkillers are NSAIDs , opioids , and local anesthetics . For consciousness (anesthetic drugs) Some anesthetics include benzodiazepines and barbiturates . The main categories of drugs for musculoskeletal disorders are: NSAIDs (including COX-2 selective inhibitors ), muscle relaxants , neuromuscular drugs , and anticholinesterases . Antibiotics , sympathomimetics , antihistamines , anticholinergics , NSAIDs , corticosteroids , antiseptics , local anesthetics , antifungals , and cerumenolytics. Bronchodilators , antitussives , mucolytics , decongestants , inhaled and systemic corticosteroids , beta2-adrenergic agonists , anticholinergics , mast cell stabilizers , leukotriene antagonists . Androgens , antiandrogens , estrogens , gonadotropin , corticosteroids , human growth hormone , insulin , antidiabetics ( sulfonylureas , biguanides / metformin , thiazolidinediones , insulin ), thyroid hormones , antithyroid drugs, calcitonin , diphosphonate , vasopressin analogues . Antifungal , alkalinizing agents , quinolones , antibiotics , cholinergics , anticholinergics , antispasmodics , 5-alpha reductase inhibitor , selective alpha-1 blockers , sildenafils , fertility medications . NSAIDs , anticholinergics , haemostatic drugs , antifibrinolytics , Hormone Replacement Therapy (HRT), bone regulators, beta-receptor agonists , follicle stimulating hormone , luteinising hormone , LHRH , gamolenic acid , gonadotropin release inhibitor , progestogen , dopamine agonists , oestrogen , prostaglandins , gonadorelin , clomiphene , tamoxifen , diethylstilbestrol . Emollients , anti-pruritics , antifungals , antiseptics , scabicides , pediculicides , tar products, vitamin A derivatives , vitamin D analogues , keratolytics , abrasives , systemic antibiotics , topical antibiotics , hormones , desloughing agents, exudate absorbents, fibrinolytics , proteolytics , sunscreens , antiperspirants , corticosteroids , immune modulators. Antibiotics , antifungals , antileprotics , antituberculous drugs , antimalarials , anthelmintics , amoebicides , antivirals , antiprotozoals , probiotics, prebiotics, antitoxins , and antivenoms. Vaccines , immunoglobulins , immunosuppressants , interferons , and monoclonal antibodies . Anti-allergics , antihistamines , NSAIDs , corticosteroids . Tonics, electrolytes and mineral preparations (including iron preparations and magnesium preparations ), parenteral nutrition , vitamins , anti-obesity drugs , anabolic drugs , haematopoietic drugs, food product drugs. Cytotoxic drugs , therapeutic antibodies , sex hormones , aromatase inhibitors , somatostatin inhibitors, recombinant interleukins , G-CSF , erythropoietin . Contrast media . A euthanaticum

999-410: The human gastrointestinal tract ), injection into the body, and by other routes ( dermal , nasal , ophthalmic , otologic , and urogenital ). Oral administration , the most common form of enteral administration, can be performed using various dosage forms including tablets or capsules and liquid such as syrup or suspension. Other ways to take the medication include buccally (placed inside

1036-468: The Geneva research site moved to a brand new campus (Horizon Secheron) in the heart of Geneva in 2006. This facility and the headquarters were closed by Merck KGaA in 2013. The building was sold back to Bertarelli family. In 2005, Serono agreed to a $ 704 million settlement with the Department of Justice to resolve civil and criminal allegations that the company engaged in a fraudulent scheme to promote

1073-575: The acquisition in 1997 of GBRI from GlaxoWelcome, becoming its Geneva based research institute named SPRI, and the Manteia Predictive Medicine spin-off, Serono also nursed the emergence of now a commercial leading massive parallel sequencing technology. 36% of Serono was sold to Merck KGaA in Sept. 2006 for €10.6 billion; Merck KGaA paid CHF 1,100 for each share. The new entity, which merges Serono with Merck's Ethicals division,

1110-643: The active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small molecules , natural products , or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology . Since sequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compound libraries against isolated biological targets which are hypothesized to be disease-modifying in

1147-399: The basis of pharmacological properties like mode of action and their pharmacological action or activity, such as by chemical properties , mode or route of administration , biological system affected, or therapeutic effects . An elaborate and widely used classification system is the Anatomical Therapeutic Chemical Classification System (ATC system). The World Health Organization keeps

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1184-400: The cheek), sublingually (placed underneath the tongue), eye and ear drops (dropped into the eye or ear), and transdermally (applied to the skin). They can be administered in one dose, as a bolus . Administration frequencies are often abbreviated from Latin, such as every 8 hours reading Q8H from Quaque VIII Hora . The drug frequencies are often expressed as the number of times a drug

1221-551: The drug Serostim for off-label uses and paid out illegal kickbacks for prescribing the drug in violation of the False Claims Act . The settlement is, to date, the ninth largest pharmaceutical settlement in U.S. history. Serono provides Fertility LifeLines as a free and confidential source of information to infertility patients. Pharmaceutical A medication (also called medicament , medicine , pharmaceutical drug , medicinal drug or simply drug )

1258-487: The pathology they are used to treat. Drug classes that are defined by their therapeutic use (the pathology they are intended to treat) include: Some drug classes have been amalgamated from these three principles to meet practical needs. The class of nonsteroidal anti-inflammatory drugs (NSAIDs) is one such example. Strictly speaking, and also historically, the wider class of anti-inflammatory drugs also comprises steroidal anti-inflammatory drugs . These drugs were in fact

1295-400: The predominant anti-inflammatories during the decade leading up to the introduction of the term "nonsteroidal anti-inflammatory drugs." Because of the disastrous reputation that the corticosteroids had got in the 1950s, the new term, which offered to signal that an anti-inflammatory drug was not a steroid, rapidly gained currency. The drug class of "nonsteroidal anti-inflammatory drugs" (NSAIDs)

1332-521: The state level, or at both state and national levels by various bodies, as is the case in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There

1369-461: Was closed in 2004 owing to its obsolescence. Research and development facilities were maintained in Geneva, Switzerland , Boston, USA , and Ivrea , Italy. It employed over 4,750 people with worldwide revenues of USD 2,586.4 million (2005). It had eight biotechnology products on the market, and more than 25 ongoing preclinical and clinical development projects at the end of 2005. Serono Headquarters and

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