title: Is this the dose for you?: the role of modeling.
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).
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. shiewmei.huang@fda.hhs.gov
authors.forename: S-M
authors.initials: SM
authors.lastname: Huang
authors.forename: A
authors.initials: A
authors.lastname: Bhattaram
authors.forename: N
authors.initials: N
authors.lastname: Mehrotra
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000367:Age Factors; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001572:Benzofurans / Q000008:administration & dosage* / Q000009:adverse effects; D015283:Citalopram / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008962:Models, Theoretical; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011409:Propylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D013110:Sphingosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000069503:Vilazodone Hydrochloride
chemical_list: D000928:Antidepressive Agents; D001572:Benzofurans; D007166:Immunosuppressive Agents; D007211:Indoles; D010879:Piperazines; D011409:Propylene Glycols; D015283:Citalopram; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine; D000069503:Vilazodone Hydrochloride