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Titolo:
The dose-response relationship in Phase I clinical trials and beyond: use,meaning, and assessment
Autore:
Emilien, G; van Meurs, W; Maloteaux, JM;
Indirizzi:
Univ Catholique Louvain, Clin Univ St Luc, Pharmacol Lab, B-1200 Brussels,Belgium Univ Catholique Louvain Brussels Belgium B-1200 B-1200 Brussels,Belgium Univ Porto, Dept Appl Math, P-4050 Porto, Portugal Univ Porto Porto Portugal P-4050 Dept Appl Math, P-4050 Porto, Portugal Univ Porto, Inst Biomed Engn, P-4050 Porto, Portugal Univ Porto Porto Portugal P-4050 nst Biomed Engn, P-4050 Porto, Portugal Univ Florida, Dept Anesthesiol, Gainesville, FL USA Univ Florida Gainesville FL USA a, Dept Anesthesiol, Gainesville, FL USA Univ Catholique Louvain, Clin Univ St Luc, Dept Neurol, B-1200 Brussels, Belgium Univ Catholique Louvain Brussels Belgium B-1200 B-1200 Brussels, Belgium
Titolo Testata:
PHARMACOLOGY & THERAPEUTICS
fascicolo: 1, volume: 88, anno: 2000,
pagine: 33 - 58
SICI:
0163-7258(200010)88:1<33:TDRIPI>2.0.ZU;2-B
Fonte:
ISI
Lingua:
ENG
Soggetto:
PHARMACOKINETIC-PHARMACODYNAMIC RELATIONSHIPS; 4 BASIC MODELS; UMBRELLA ALTERNATIVES; HEALTHY-VOLUNTEERS; LOOP DIURETICS; TOLERANCE; CAFFEINE; PERFORMANCE; FUROSEMIDE; KINETICS;
Keywords:
dose response; quantitative; quantal; clinical trial; pharmacodynamic; pharmacokinetic; phase I;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
105
Recensione:
Indirizzi per estratti:
Indirizzo: Emilien, G 127 Rue Henri Prou, F-78340 Les Clayes Bois, France 127 Rue Henri Prou Les Clayes Bois France F-78340 ois, France
Citazione:
G. Emilien et al., "The dose-response relationship in Phase I clinical trials and beyond: use,meaning, and assessment", PHARM THERA, 88(1), 2000, pp. 33-58

Abstract

Knowledge of the relationships among dose, drug concentration in blood, and clinical response is important for the safe and effective use of drugs inindividual patients. Recently, pharmacokinetic-pharmacodynamic modeling has been taking an increasingly important place in clinical pharmacology because of its role in the determination of the optimal dosage of a new drug. Its primary objective is also to identify the characterization and prediction of the time course of drug effects under physiological and pathological conditions. Dose-response studies are useful in Phase I for assessing drug tolerance and safety, and invaluable in Phase II for characterizing drug efficacy. Apart from the confirmation of efficacy, the acquired information may help to investigate the shape and location of the dose-response curve, the choice of an appropriate therapeutic starting dose, the identification ofoptimal strategies for individual dose adjustments, and the determination of a maximal dose beyond which additional benefit is unlikely to be obtained. Recent development of pharmacodynamic models such as the mechanism-basedindirect effect model may permit the identification of the physiological component of drug action that is affected by disease, other medications, gender, and other variables. Assessment of dose response should be an integralcomponent of drug development, with studies designed to assess dose response an inherent part of establishing the safety and efficacy of the drug. Drug development can be enhanced with a good understanding of dose-response characteristics and ultimately the benefit/risk ratio of a drug. (C) 2000 Elsevier Science Inc. All rights reserved.

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Documento generato il 05/12/20 alle ore 00:10:25