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Titolo:
Relevance of the 10X uncertainty factor to the risk assessment of drugs used by children and geriatrics
Autore:
Skowronski, GA; Abdel-Rahman, MS;
Indirizzi:
Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Physiol & Pharmacol, Newark, NJ 07103 USA Univ Med & Dent New Jersey Newark NJ USA 07103 acol, Newark, NJ 07103 USA
Titolo Testata:
HUMAN AND ECOLOGICAL RISK ASSESSMENT
fascicolo: 1, volume: 7, anno: 2001,
pagine: 139 - 152
SICI:
1080-7039(200102)7:1<139:ROT1UF>2.0.ZU;2-K
Fonte:
ISI
Lingua:
ENG
Soggetto:
CRITICALLY ILL INFANTS; CLINICAL-PHARMACOLOGY; HUMAN VARIABILITY; RENAL-FUNCTION; PHARMACOKINETICS; PHARMACODYNAMICS; BUMETANIDE; DISPOSITION; METOPROLOL; IBUPROFEN;
Keywords:
human sensitivity; safety factor; kinetics; dynamics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Agriculture,Biology & Environmental Sciences
Citazioni:
53
Recensione:
Indirizzi per estratti:
Indirizzo: Abdel-Rahman, MS Univ Med & Dent New Jersey, New Jersey Med Sch, Dept Physiol & Pharmacol, Room I-681,185 S Orange Ave, Newark, NJ 07103 USA Univ Med& Dent New Jersey Room I-681,185 S Orange Ave Newark NJ USA 07103
Citazione:
G.A. Skowronski e M.S. Abdel-Rahman, "Relevance of the 10X uncertainty factor to the risk assessment of drugs used by children and geriatrics", HUM ECOL R, 7(1), 2001, pp. 139-152

Abstract

Conventional risk assessment practices utilize a tenfold uncertainty factor (UF) to extrapolate from the general human population to sensitive subgroups, such as children and geriatrics. This study evaluated whether the tenfold UF can be reduced when pharmacokinetic and pharmacodynamic data for pharmaceuticals used by children and geriatrics are incorporated into the riskassessment for human sensitivity. Composite factors (kinetics x dynamics) were calculated from data-derived values for bumetanide, furosemide, metoprolol, atenolol, naproxen, and ibuprofen. For the compounds examined, all ofthe composite factors were lower than 10. Furthermore, 8 of the 12 composite factors were less than 5.5. Incorporation of human kinetic and dynamic data into risk assessment can aid in reducing the uncertainties associated with sensitive subgroups and further study is encouraged.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/01/20 alle ore 21:53:19