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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 b ...
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Clinical Trials
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 ...
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Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ...
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Contract Research Organisations
In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and Real world evidence. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.). Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. However, the ...
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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 Flic Gabbay. 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 establish ...
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Royal College Of Physicians
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, the RCP is the oldest medical college in England. It set the first international standard in the classification of diseases, and its library contains medical texts of great historical interest. The college is sometimes referred to as the Royal College of Physicians of London to differentiate it from other similarly named bodies. The RCP drives improvements in health and healthcare through advocacy, education and research. Its 40,000 members work in hospitals and communities across over 30 medical specialties with around a fifth based in over 80 countries worldwide. The college hosts six training faculties: the Faculty of Forensic and Legal Medicine, the Faculty for Pharmaceutical Medicine, the Faculty of Occupational Medicine the Fac ...
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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. Th ...
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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 modelin ...
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Clinical Pharmacology
Clinical pharmacology has been defined as "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 patie ...
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