Download BarCharts QuickStudy Pharmacology by Becky Rodda, Suzanne L., Ph.D. Tinsley PDF

By Becky Rodda, Suzanne L., Ph.D. Tinsley

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A large Vd may indicate that the drug is concentrated intracellularly, with a resulting low concentration in the plasma. Many weak bases, such as the antidepressant fluoxetine (PROZAC), have a large Vd (40 to 55 L) because of the phenomenon of intracellular ion trapping. Weak bases are less ionized within plasma than they are within cells because intracellular fluid usually has a lower pH than extracellular fluid. After a weak base diffuses into a cell, a larger fraction is ionized in the more acidic intracellular fluid.

However, because studies of chronic toxicity of new drugs in animals may require years for completion, it is usually possible to begin human studies while animal studies are being completed if the acute and subacute toxicity studies have not revealed any abnormalities in animals. THE INVESTIGATIONAL NEW DRUG APPLICATION The Food and Drug Administration (FDA) must approve an application for an investigational new drug (IND) before the drug can be distributed for the purpose of conducting studies in human subjects.

1 ED50 ED99 LD1 LD50 10 Log dose of drug Y FIGURE 3-6. Quantal dose-response relationships. The dose-response 75 curves for a therapeutic effect (sleep) and a toxic effect (death) of a drug are compared. The ratio of the LD50 to the ED50 is the therapeutic index. The ratio of the LD1 to the ED99 is the certain safety factor. ED, Effective dose; LD, lethal dose. 1 1 10 Log dose of agonist FIGURE 3-5. Graded dose-response relationships. A, The dose-response curves of three agonists (R, S, and T) are compared.

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