Pharmaceutical Medicine
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Pharmaceutical Medicine
Pharmaceutical medicine is a medical discipline concerned with the discovery, evaluation, registration, monitoring and clinical aspects of pharmaceutical development. All medical specialties overlap to some extent, and likewise the boundaries of pharmaceutical medicine are elastic. But, at its centre is the clinical testing of medicines, translation of pharmaceutical drug research into new medicines, safety and well-being of patients and research participants in clinical trials, and understanding the safety profile of medicines and their benefit-risk balance. Pharmaceutical physicians work in the pharmaceutical industry, universities / medical schools, drug regulatory authorities and contract research organisations, but have a close affinity with their medical colleagues elsewhere. As a postgraduate medical discipline, pharmaceutical medicine has a recognised international syllabus, training courses with examinations and qualifications, its own research methodologies, professional ...
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Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ...
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Pharmaceutical Industry
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury. Pharmaceutical companies may deal in generic drugs, branded drugs, or both, in different contexts. Generic materials are without the involvement of intellectual property, whereas branded materials are protected by chemical patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics and total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, ...
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Contract Research Organisations
A contract is an agreement that specifies certain legally enforceable rights and obligations pertaining to two or more parties. A contract typically involves consent to transfer of goods, services, money, or promise to transfer any of those at a future date. The activities and intentions of the parties entering into a contract may be referred to as contracting. In the event of a breach of contract, the injured party may seek judicial remedies such as damages or equitable remedies such as specific performance or rescission. A binding agreement between actors in international law is known as a treaty. Contract law, the field of the law of obligations concerned with contracts, is based on the principle that agreements must be honoured. Like other areas of private law, contract law varies between jurisdictions. In general, contract law is exercised and governed either under common law jurisdictions, civil law jurisdictions, or mixed-law jurisdictions that combine elem ...
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Faculty Of Pharmaceutical Medicine
The Faculty of Pharmaceutical Medicine (FPM) is a faculty of the three Royal Colleges of Physicians of the United Kingdom (the Royal College of Physicians London, the Royal College of Physicians Edinburgh and the Royal College of Physicians and Surgeons of Glasgow). It is a UK-based professional membership organisation with 1,600 members; physicians with a professional interest in the speciality of pharmaceutical medicine, the science of discovering, developing and testing new drugs, their regulation, and monitoring them for safety both during development and when they are prescribed. FPM is a registered charity and ultimately exists to bring about an improvement in health in patients and the general population. The president of FPM is Dr Sheuli Porkess. History In 1976 the three Royal Colleges of Physicians of the UK agreed to grant the first Diploma in Pharmaceutical Medicine to be gained by examination, and a two-year training course for pharmaceutical physicians was establ ...
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Royal College Of Physicians
The Royal College of Physicians of London, commonly referred to simply as the Royal College of Physicians (RCP), is a British professional membership body dedicated to improving the practice of medicine, chiefly through the accreditation of physicians by examination. Founded by royal charter from King Henry VIII in 1518, as the College of Physicians, the RCP is the oldest medical college in England. The RCP's home in Regent's Park is one of the few post-war buildings to be listed at Grade I. In 2016 it was announced that the RCP was to open new premises in Liverpool at The Spine, a new building in the Liverpool Knowledge Quarter. The Spine opened in May 2021. History The college was incorporated as "the President and College or Commonalty of the Faculty of Physic in London" when it received a royal charter in 1518, affirmed by Act of Parliament in 1523. It is not known when the name "Royal College of Physicians of London" was first assumed or granted. It came into use aft ...
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Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process—from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials—to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These h ...
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Pharmacoeconomics
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. It is a sub-discipline of health economics. A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of life) of a pharmaceutical product. Pharmacoeconomic studies serve to guide optimal healthcare resource allocation, in a standardized and scientifically grounded manner. Economic evaluation Pharmacoeconomics centers on the economic evaluation of pharmaceuticals, and can use cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis or cost-utility analysis. Quality-adjusted life years have become the dominant outcome of interest in pharmacoeconomic evaluations, and many studies employ a cost-per-QALY analysis. Economic evaluations are carried out alongside randomized controlled trials and using methods of decision-analytic ...
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Clinical Pharmacology
Clinical pharmacology is "that discipline that teaches, does research, frames policy, gives information and advice about the actions and proper uses of medicines in humans and implements that knowledge in clinical practice". Clinical pharmacology is inherently a translational discipline underpinned by the basic science of pharmacology, engaged in the experimental and observational study of the disposition and effects of drugs in humans, and committed to the translation of science into evidence-based therapeutics. It has a broad scope, from the discovery of new target molecules to the effects of drug usage in whole populations. The main aim of clinical pharmacology is to generate data for optimum use of drugs and the practice of 'evidence-based medicine'. Clinical pharmacologists have medical and scientific training that enables them to evaluate evidence and produce new data through well-designed studies. Clinical pharmacologists must have access to enough patients for clinical c ...
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