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section i (pharmacokinetic and clinical evaluation)
section i (pharmacokinetic and clinical evaluation)
Last Update: 2011-10-23
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conduct of pharmacokinetic studies in animals verabschiedet im märz 2000
adottate nel novembre 2000
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concept paper on the development of a cpmp note for guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins.
concept paper on the development of a cpmp note for guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins.
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der einfluss des geschlechts auf die pharmakokinetik von rufinamid wurde mit hilfe eines populationspharmakokinetischen modells (population pharmacokinetic modelling) untersucht.
i modelli farmacocinetici di popolazione sono stati utilizzati per valutare l’influenza del sesso sulla farmacocinetica della rufinamide.
Last Update: 2017-04-26
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pharmakokinetik bei speziellen patientengruppen geschlecht der einflusses des geschlechts auf die pharmakokinetik von rufinamid wurde mit hilfe des “ population pharmacokinetic modelling“ untersucht.
farmacocinetica in gruppi di pazienti speciali sesso i modelli farmacocinetici di popolazione sono stati utilizzati per valutare l’ influenza del sesso sulla farmacocinetica della rufinamide.
Last Update: 2012-04-11
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die pharmakokinetischen wechselwirkungen zwischen rufinamid und anderen antiepileptika wurden bei patienten mit epilepsie unter verwendung eines populationspharmakokinetischen modells (population pharmacokinetic modelling) untersucht.
le interazioni farmacocinetiche tra rufinamide e altri farmaci antiepilettici sono state valutate in pazienti affetti da epilessia, usando modelli farmacocinetici di popolazione.
Last Update: 2017-04-26
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ein „ population pharmacokinetic/pharmacodynamic modelling“ zeigte, dass die reduktion der häufigkeit der krämpfe insgesamt und der häufigkeit tonisch-atonischer anfälle, die verbesserung
i modelli farmacocinetici/ farmacodinamici di popolazione hanno dimostrato che la riduzione della frequenza delle crisi totali e toniche-atoniche, il miglioramento della valutazione globale della gravità delle crisi e l’ aumento della probabilità di riduzione della frequenza delle crisi erano dipendenti dalle concentrazioni di rufinamide.
Last Update: 2011-10-23
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adjustment for baseline covariates points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials points to consider on clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment note for guidance on clinical investigation of medicinal products for the treatment of psoriasis points to consider on allergic rhino-conjuctivitis addendum to the note for guidance on modified release oral and transdermal dosage forms:
adjustment for baseline covariates points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials points to consider on clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment note for guidance on clinical investigation of medicinal products for the treatment of psoriasis points to consider on allergic rhino-conjuctivitis addendum to the note for guidance on modified release oral and transdermal dosage forms:
Last Update: 2011-10-23
Usage Frequency: 1
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