PSY 356 drugsafety and dose response

PSY 356 drugsafety - Drug Safety and Effectiveness A Manufacturers must demonstrate both that a drug is effective for the claimed therapeutic use

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Drug Safety and Effectiveness A. Manufacturers must demonstrate both that a drug is effective for the claimed therapeutic use and that it is safe to use in a wide population a. Effectiveness is determined in animal experiments and human trials b. Safety -the potential for the drug to cause adverse affects A. Variability in response to drugs happens because of a. Genetics b. Population variants c. Rates of absorption and metabolism d. Previous experience with drug use e. Physical, psychological, and emotional states A. Variability usually follows a predictable pattern (Gaussian distribution) B. Therapeutic Index (TI) -the ratio of the LD 50 to the ED 50 used as an index of the relative safety of drugs a. ED 50 - dose of drug that produces the desired effect in 50% of the subjects b. LD 50 -lethal dose for 50% of the subjects A. Drug Interactions -the effects of one drug can be modified by the concurrent administration of another drug a. Interactions are beneficial when two drugs used together achieve therapeutic benefit when a single drug alone is insufficient b. Detrimental actions can have either a pharmacokinetic or a pharmacodynamic basis A. Drug toxicity -Unwanted effects fall into one of two categories i. It is important to categorize harmful effects of drug in terms of their severity and to distinguish between effects that cause temporary inconvenience or discomfort and effects that can lead to organ damage, permanent disability , or even death ii. The distinction between therapeutic and side effects is relative and depends on the purpose for which the drug is administered iii. To achieve the desired therapeutic effect of effects, some side effects often must be tolerated a. Effects that are related to the principle and predictable pharmacological actions of a drug
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This note was uploaded on 05/05/2011 for the course PSY 356 taught by Professor Simson during the Spring '11 term at Miami University.

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PSY 356 drugsafety - Drug Safety and Effectiveness A Manufacturers must demonstrate both that a drug is effective for the claimed therapeutic use

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