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Pharmacology is not identical with pharmacy, though in common usage the two are at times confused.
Medicine development and safety testingIf the structure of a medicine is altered slightly, this will slightly alter the medicine's properties. This means when a useful activity has been identified, chemists will make many similar compounds called analogues, to try and maximise the beneficial effects. This development phase can take up to 3 years typically and is expensive.[2] 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 dispensing, like tablet or aerosol. After lots of testing, which can take up to 6 years the new medicine is ready for marketing.[2]
Drug legislation and safetyIn 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:
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.[1] 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. Scientific backgroundThe study of chemicals requires intimate knowledge of the biological system affected. With the knowledge of cell biology and biochemistry increasing, the field of pharmacology has also changed substantially. It has become possible, through molecular analysis of receptors, to design chemicals that act on specific cellular signalling or metabolic pathways by affecting sites directly on cell-surface receptors (which modulate and mediate cellular signalling pathways controlling cellular function). A chemical has, from the pharmacological point-of-view, various properties. Pharmacokinetics describes the effect of the body on the chemical (e.g. half-life and volume of distribution), and pharmacodynamics describes the chemical's effect on the body (desired or toxic). When describing the pharmacokinetic properties of a chemical, pharmacologists are often interested in ADME:
Medication is said to have a narrow or wide therapeutic index or therapeutic window. This describes the ratio of desired effect to toxic effect. A compound with a narrow therapeutic index (close to one) exerts its desired effect at a dose close to its toxic dose. A compound with a wide therapeutic index (greater than five) exerts its desired effect at a dose substantially below its toxic dose. Those with a narrow margin are more difficult to dose and administer, and may require therapeutic drug monitoring (examples are warfarin, some antiepileptics, aminoglycoside antibiotics). Most anti-cancer drugs have a narrow therapeutic margin: toxic side-effects are almost always encountered at doses used to kill tumours. Drugs used as medicinesA medication is a licensed drug (chemical) taken to cure, prevent or reduce symptoms of an illness or medical condition. Medications are generally divided into two groups -- over-the-counter (OTC) medications, which are available without special restrictions, and Prescription only medicines (POM), which must be prescribed by a physician. Most OTC medication is generally considered to be safe enough that most persons will not hurt themselves accidentally by taking it as instructed. Many countries, such as the UK have a third category of pharmacy medicines which can only be sold in registered pharmacies, by or under the supervision of a pharmacist. However, the precise distinction between OTC and prescription depends on the legal jurisdiction. Medications are typically produced by pharmaceutical companies and are often patented. Those that are not patented are called generic drugs. EducationThe study of pharmacology is typically offered as an advanced degree program. In the United States, a few institutions have it available as an undergraduate major or concentration that enables graduates to be entry-level lab technicians in the field of drug design and discovery. The following universities offer the undergraduate major:
See also
Footnotes
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