
- •Apothecary
- •History
- •Other Mentions In Creative Literature
- •Noted Apothecaries
- •See also
- •References
- •Overview
- •Etymology
- •Function
- •Examples
- •See also
- •References
- •Clinical pharmacy
- •[Edit] See also
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- •Compounding
- •History
- •New England Compounding Center incident
- •Roles During research and development
- •Patients with unique or unusual medication needs
- •Personalized medicine and polypharmacy
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- •Regulation in the United States
- •Analogy to "off-label" use
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- •References
- •External links
- •Consultant pharmacist
- •United States
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- •See also
- •Herbalism
- •History
- •Ancient times
- •Middle Ages
- •Early modern era
- •Modern herbal medicine
- •Biological background
- •Clinical tests
- •Prevalence of use
- •Herbal preparations
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- •Extinction of medicinal plant species
- •See also
- •References
- •Further reading
- •History of pharmacy
- •Prehistoric pharmacy
- •Antiquity
- •Middle Ages
- •See also
- •References
- •Hospice
- •History Early development
- •Rise of the modern hospice movement
- •Hospice care
- •North America Canada
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- •Further reading
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- •Hospital pharmacy
- •Sterile production
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- •Hospital
- •Etymology
- •General
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- •Teaching
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- •Medical education
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- •See also
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- •External links
- •Medical ethics
- •History
- •Values in medical ethics
- •Autonomy
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- •Double effect
- •Conflicts between autonomy and beneficence/non-maleficence
- •Euthanasia
- •Informed consent
- •Confidentiality
- •Criticisms of orthodox medical ethics
- •Importance of communication
- •Control and resolution
- •Guidelines
- •Ethics committees
- •Medical ethics in an online world
- •Cultural concerns
- •Truth-telling
- •Online business practices
- •Conflicts of interest
- •Referral
- •Vendor relationships
- •Treatment of family members
- •Sexual relationships
- •Futility
- •Sources and references
- •External links
- •Medical psychology
- •Behavioral medicine
- •Certifications
- •References
- •See also
- •External links
- •Institutions
- •Branches
- •Basic sciences
- •'Medicine' as a specialty
- •Diagnostic specialties
- •Other major specialties
- •Interdisciplinary fields
- •Education
- •Medical ethics
- •Legal controls
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- •Honors and awards
- •History
- •Ancient world
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- •Patron saints
- •Nobel Prize in Physiology or Medicine
- •Background
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- •Diplomas
- •Award money
- •Ceremony and banquet
- •Laureates
- •Time factor and death
- •Controversial inclusions and exclusions
- •Limits on number of awardees
- •Years without awards
- •References
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- •Online pharmacy
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- •Discussion
- •International consumers
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- •Enforcement
- •Mail fraud
- •Uk consumers
- •See also
- •References
- •External links
- •Pharmacist
- •Nature of the work
- •Education and credentialing
- •Practice specialization
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- •Australia
- •Japan History
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- •United Kingdom
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- •Vietnam
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- •Education
- •Specialization and credentialing
- •Earnings and wages
- •Noted people who were pharmacists
- •See also
- •References
- •Further reading
- •External links
- •Pharmacognosy
- •Introduction
- •Issues in phytotherapy
- •Constituents and drug synergysm
- •Herb and drug interactions
- •Natural products chemistry
- •Loss of biodiversity
- •Sustainable sources of plant and animal drugs
- •Acceptance in the United States
- •External links
- •References
- •Pharmacology
- •Divisions
- •Environmental pharmacology
- •Scientific background
- •Medicine development and safety testing
- •Drug legislation and safety
- •Education
- •See also
- •Footnotes
- •[Edit] External links
- •Pharmacopoeia
- •Etymology
- •History
- •City pharmacopoeia
- •National pharmacopoeia
- •International pharmacopoeia
- •Medical preparations, uses and dosages
- •See also
- •References
- •External links
- •Pharmacy automation
- •History
- •Chronology
- •Global variations
- •Current state of the industry
- •Technological changes and design improvements
- •Other pharmacy-dispensing concerns besides counting
- •Future development
- •Liquid Oral doses (Childs, aging, oncology...)
- •Repackaging process and stability data
- •See also
- •References
- •External links
- •Videos of robots in action
- •Pharmacy technician
- •See also
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- •External links
- •Pharmacy
- •Disciplines
- •Professionals
- •Pharmacists
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- •History
- •Types of pharmacy practice areas
- •Community pharmacy
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- •Compounding pharmacy
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- •Veterinary pharmacy
- •Nuclear pharmacy
- •Military pharmacy
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- •Issues in pharmacy Separation of prescribing from dispensing
- •The future of pharmacy
- •Pharmacy journals
- •See also
- •Symbols
- •References
- •External links
- •Philosophy of healthcare
- •Ethics of healthcare
- •Medical ethics
- •Nursing ethics
- •Business ethics
- •Political philosophy of healthcare
- •Patients' Bill of Rights
- •Health insurance
- •Research and scholarship
- •Clinical trials
- •Quality assurance
- •Birth and death Reproductive rights
- •Birth and living
- •Death and dying
- •Role development
- •See also
- •References
- •External links
Medicine development and safety testing
Development of medication is a vital concern to medicine, but also has strong economical and political implications. To protect the consumer and prevent abuse, many governments regulate the manufacture, sale, and administration of medication. In the United States, the main body that regulates pharmaceuticals is the Food and Drug Administration and they enforce standards set by the United States Pharmacopoeia. In the European Union, the main body that regulates pharmaceuticals is the EMEA and they enforce standards set by the European Pharmacopoeia.
The metabolic stability and the reactivity of a library of candidate drug compounds have to be assessed for drug metabolism and toxicological studies. Many methods have been proposed for quantitative predictions in drug metabolism; one example of a recent computational method is SPORCalc.[10] If the chemical structure of a medicinal compound is altered slightly, this could slightly or dramatically alter the medicinal properties of the compound depending on the level of alteration as it relates to the structural composition of the substrate or receptor site on which it exerts its medicinal effect, a concept referred to as the structural activity relationship (SAR). This means that when a useful activity has been identified, chemists will make many similar compounds called analogues, in an attempt to maximize the desired medicinal effect(s) of the compound. This development phase can take anywhere from a few years to a decade or more and is very expensive.[11]
These new analogues need to be developed. It needs to be determined how safe the medicine is for human consumption, its stability in the human body and the best form for delivery to the desired organ system, like tablet or aerosol. After extensive testing, which can take up to 6 years, the new medicine is ready for marketing and selling.[11]
As a result of the long time required to develop analogues and test a new medicine and the fact that of every 5000 potential new medicines typically only one will ever reach the open market, this is an expensive way of doing things, costing millions of dollars. To recoup this outlay pharmaceutical companies may do a number of things:[11]
Carefully research the demand for their potential new product before spending an outlay of company funds.[11]
Obtain a patent on the new medicine preventing other companies from producing that medicine for a certain allocation of time.[11]
Drug legislation and safety
In the United States, the Food and Drug Administration (FDA) is responsible for creating guidelines for the approval and use of drugs. The FDA requires that all approved drugs fulfill two requirements:
The drug must be found to be effective against the disease for which it is seeking approval.
The drug must meet safety criteria by being subject to extensive animal and controlled human testing.
Gaining FDA approval usually takes several years to attain. Testing done on animals must be extensive and must include several species to help in the evaluation of both the effectiveness and toxicity of the drug. The dosage of any drug approved for use is intended to fall within a range in which the drug produces a therapeutic effect or desired outcome.[12]
The safety and effectiveness of prescription drugs in the U.S. is regulated by the federal Prescription Drug Marketing Act of 1987.
The Medicines and Healthcare products Regulatory Agency (MHRA) has a similar role in the UK.