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What is the margin of safety in LD50 200mg and ED50 60mg?
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The dose of a drug which kills 50 animals was 60mgkg the dose of a drug which cured 50 animals was20mgkg calculate the therapeutic index of the drug?
The therapeutic index of a drug is determined by dividing the lethal dose (LD50) by the effective dose (ED50). In this case: Therapeutic index = LD50/ED50 = 60mg/kg / 20mg/kg = 3. This means that the drug has a therapeutic index of 3, indicating a relatively safe drug with a wide margin of safety.
What is the margin of safety LD50 ED50?
The margin of safety is the dose of a drug that is lethal for 1% of tested animals divided by the dose that produces the maximum effect for 99% of tested animals. The larger this ratio is, the better you toxicology data will (and thus, the safer the drug will be)
Where is the therapeutic index of a drug listed?
Having worked in the pharma industry in senior positions in clinical drug development for 30 years, the therapeutic index of a drug is essentiallya qualitative concept of risk:benefit ratio for one drug vs another and is NOT a real number. There is no agreed upon formula for computing the therapeutic index of a drug using clinical results. The reason the formula does not exist is that it would require a consensus agreement among experts for each disease regarding the definition of a clinical response (patients usually show graded responses, not simply full response or no response) and a consensus definition of the clinical toxicity of a drug. For example, if a medication produces side effects consisting of dose-dependent increases in blood pressure, decreases in white blood cell counts and vomiting--what criteria shall be selected for a toxic risk? In animal studies. the ratio of LD50/ED50 (dose in a species that kills one half of the animals divided by the dose that is effective in the disease model in one half of the test animals) is sometimes computed and can be helpful in deciding which of several potential drug candidates is to be selected for development. It is probably possible to find in select publications, sufficient information to compute a therapeutic index that compares several drugs using a uniform definition of the dose needed to produce the same therapeutic benefit and the dose needed (on average) to produce a side effect of sufficient severity to qualify as a dose-limiting problem. Even in this case, the therapeutic index would be essentially an ad hoc determination produced by the author or reviewer. It would likely not be regarded by others as the therapeutic index for the drugs assessed because other experts would likely employ a different definition of side effects of concern.
What is an acceptable therapeutic index for approval by the FDA?
The FDA should publish Therapeutic index (TI) values for all drugs but they do not. Therefore it is not possible to know what the FDA considers acceptable. The therapeutic index (toxic dose/effective dose) should not be less than 1 because a drug should have beneficial actions at the same or lower plasma concentrations that cause toxicity. However, cytotoxic drugs to treat cancer, by definition are toxic in order to do their beneficial action of killing rapidly dividing cells. Therefore a therapeutic index of 1 is not unusual for a chemotherapy drug. Most drugs have a therapeutic index of 2 or higher. A TI of 2 is a dangerous drug and the patient must be watched carefully for signs of toxicity. Drugs with a TI of 5 or 10 are safer drugs. Some drugs with great selectivity and minimal toxicity have TIs of 50 to 100. These can be given as on large dose that will continue to work well for several days but drugs that can be used this way are unusual, like a few of the antibiotics that kill prokaryotic bacteria but have little or no effect on eukaryotic human cells. The most serious problem we are facing in medicine today is the use of many drugs together (polypharmacy) that make any drug with a low therapeutic index far more danger. Interactions that raise plasma concentrations of low TI drugs can be lethal even if the drug interaction is a C or D level interaction and not the X level drug interactions that are typically monitored. Far too many people die or are seriously harmed due to drug interactions with drugs having low therapeutic indices of approximately 2. We need to get the FDA to publish all of the TI values. The drug database companies would like to publish these numbers to improve patient safety. Without TI values, electronic record and CPOE systems are not reducing patient deaths or lower health care costs.
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