Abstract
To make an informed benefit-risk evaluation of a drug, a range of doses needs to be evaluated and its dose-response and exposure-response relationships for safety and effectiveness assessed during drug development (International Conference on Harmonisation E4). Once a safe and effective population dose (or doses) has been determined for indicated use(s), the individual patient dose can then be adjusted based on patient-specific factors (e.g., age, race, genetics, organ functions, concomitant medications).
MeSH terms
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Age Factors
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Antidepressive Agents / administration & dosage*
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Antidepressive Agents / adverse effects
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Benzofurans / administration & dosage*
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Benzofurans / adverse effects
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Citalopram / administration & dosage*
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Citalopram / adverse effects
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Dose-Response Relationship, Drug
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Fingolimod Hydrochloride
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Humans
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Immunosuppressive Agents / administration & dosage*
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Immunosuppressive Agents / adverse effects
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Indoles / administration & dosage*
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Indoles / adverse effects
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Models, Theoretical
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Piperazines / administration & dosage*
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Piperazines / adverse effects
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Propylene Glycols / administration & dosage*
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Propylene Glycols / adverse effects
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Risk Assessment
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Sphingosine / administration & dosage
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Sphingosine / adverse effects
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Sphingosine / analogs & derivatives*
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Vilazodone Hydrochloride
Substances
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Antidepressive Agents
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Benzofurans
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Immunosuppressive Agents
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Indoles
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Piperazines
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Propylene Glycols
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Citalopram
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Fingolimod Hydrochloride
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Sphingosine
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Vilazodone Hydrochloride