Term
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Definition
| Adequate well controlled human studies that fail to demonstrate risk in pregnancy |
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Term
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Definition
| animal repro studies may show adverse effect, but adequate and well controlled studies in pregnant women |
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Term
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Definition
| adverse effects, but potential benefits may warrant use of the drug |
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Term
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Definition
| positive evidence of human fetal risk based adverse reaction data |
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Term
| when should blackbox warnings be issued? |
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Definition
adverse rxn so in proportion to benefit
preventable serious adverse effects |
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Term
| what makes drugs poisonous? |
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Definition
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Term
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Definition
| dosage of a substance which kills 50% of the animals in a particular group |
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Term
| how is the therapeutic index is calculated how? |
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Definition
| dividing the LD50 or TD50 by ED50 |
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Term
| relationship b/t TI and safety margin |
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Definition
| larger the TI, the greater the safety margin |
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Term
| what is determined by the NOAEL? |
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Definition
ADI
Tolerable daily intake
Threshold limit value |
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