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the process can be accelerated. For example, efavirenz was thought to offer a benefi t to patients with acquired immune defi ciency syndrome (AIDS), a potentially fatal immune disorder; and was pushed through because of the progressive nature of AIDS and the lack of a cure. All literature associated with these drugs indicates that SAMPLE diormed teers are xpenses and penses volunteers are volunteers are lly candidates for y candidates for y exert unknown and t unknown and ion, the cyclical changes lical changes ther complexity. However, her complexity. However, n provided they are using con- provided they are using cona negative pregnancy test or are negative pregnancy test or are roduce sperm daily, so there is less sperm daily, so there is less destruction or alteration of the sperm. or alteration of the sperm. the drug under test are given to the volun- t are given to the volunInvestigators obtain data on how the drug is absorbed, metabolized and excreted; the biological effects drug; adverse effects and toxicity and also the appro- adverse effects and toxicity and also the approdosage for subsequent studies. At the end of pha for subsequent studies. At the end of pha ies, many drugs are dropped from the process b rugs are dropped from the process b they may cause unacceptable adverse effects, for example. phase I studies are successful, then investigations to phase II studies. to phase II Phase II Studies Phase II studies are the fi are the fi rst opportu rst opport gators to try the drug on patients the drug is designed to treat. Patients the drug is designed to treat. sible benefi ts of the drug and of the drug udy. Those patients w ose patients w med about possi ed about possi ate the dr performed at various following anticipated. with patients. unacceptable adverse effects. adverse effects. t-to-risk ratio, meaning that the therarovides does not outweigh the risk of s does not outweigh the risk of adverse effects that it causes. that it causes. re effective than other drugs already on the er drugs already on the making the cost of continued research and production less attractive to the drug company. drug that continues to show promise as a therapeutic that continues to show promise as a therapeutic agent receives additional scrutiny in phase III studies. Phase III Studies Phase III studies involve use of the drug in involve use of the drug group (250 to >1000 subjects) for a pe As in phase II studies, the drug under with either a placebo or an existing with either a placebo The larger group size enable The larger g the drug in patients from di e drug in patie ethnicity, and others. Pat ethnicity, and other monitored for any ad monitored for any a adverse effects are re adverse effects are r population and population Prescribers so Prescribers s any sympt y symp reporte the d 8 PART I — Introduction to Nursing Pharmacology long-term effects and other information about the drug may not yet be known. The drugs listed in this book will have undergone rigorous testing and approval for sale to the public, either with or without a prescription from a health care provider. An approved drug is given a trade name by the pharmaceutical company that developed it. The generic name of a drug is the original designation that the drug was given when the drug company applied for the approval process. Chemical names are names that refl ect the chemical structure of a drug. See Box 1.1 for examples of drug names. Some drugs are known by all of the three names. It can be confusing to study drugs when so many different names are used for the same compound. In this text, only the generic name will appear. The European Union requires manufacturers to use the Recommended International Nonproprietary Name (rINN) for all medicines. In many cases, the rINN was identical to the British Approved Name (BAN). Wherever the two were different, the BAN was changed to the rINN. There are two exceptions to this general rule: adrenaline and noradrenaline are the BANs, whereas epinephrine and norepinephrine are the rINNs. In this text, the BAN names adrenaline and noradrenaline are used as does the British National Formulary . Continual Evaluation After a drug is approved for marketing, it enters a phase of
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