Estimating and interpreting the pharmacokinetic profiles of individual patients with hemophiliaA or B using a population pharmacokinetic approach: communication from the SSC of the ISTH

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F17%3A00067847" target="_blank" >RIV/65269705:_____/17:00067847 - isvavai.cz</a>

Výsledek na webu

<a href="http://onlinelibrary.wiley.com/doi/10.1111/jth.13867/abstract;jsessionid=6105F50F2D378DFF2F470B90D030285E.f02t04" target="_blank" >http://onlinelibrary.wiley.com/doi/10.1111/jth.13867/abstract;jsessionid=6105F50F2D378DFF2F470B90D030285E.f02t04</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/jth.13867" target="_blank" >10.1111/jth.13867</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Estimating and interpreting the pharmacokinetic profiles of individual patients with hemophiliaA or B using a population pharmacokinetic approach: communication from the SSC of the ISTH

Popis výsledku v původním jazyce

The ISTH SSC on Factor VIII/IX has previously issued guidelines for studies assessing the pharmacokinetics (PK) of factor concentrates [1, 2]. It suggested drawing 10 or 11 blood samples over a period of 32-48 h or 50-72 h, after infusing 25-50 IU kg-1 or 50-75 IU kg-1, respectively, for FVIII or FIX, in cohorts of 12-15 patients with a crossover design. Such PK studies are not ideal for tailoring the treatment of individual patients, mostly because of the requirement for several blood samples. Owing to broad interindividual variation, the individual disposition of FVIII and FIX cannot be predicted from morphometric characteristics and average PK parameters, but requires empirical assessment in each individual [3-6]. Previous guidance of this ISTH SSC described the PK methodology for the prediction of individual trough levels of FVIII [7]. The present communication, building on recent advances in the population pharmacokinetics (PopPK) of FVIII and FIX [8], adds to the former documents.

Název v anglickém jazyce

Estimating and interpreting the pharmacokinetic profiles of individual patients with hemophiliaA or B using a population pharmacokinetic approach: communication from the SSC of the ISTH

Popis výsledku anglicky

The ISTH SSC on Factor VIII/IX has previously issued guidelines for studies assessing the pharmacokinetics (PK) of factor concentrates [1, 2]. It suggested drawing 10 or 11 blood samples over a period of 32-48 h or 50-72 h, after infusing 25-50 IU kg-1 or 50-75 IU kg-1, respectively, for FVIII or FIX, in cohorts of 12-15 patients with a crossover design. Such PK studies are not ideal for tailoring the treatment of individual patients, mostly because of the requirement for several blood samples. Owing to broad interindividual variation, the individual disposition of FVIII and FIX cannot be predicted from morphometric characteristics and average PK parameters, but requires empirical assessment in each individual [3-6]. Previous guidance of this ISTH SSC described the PK methodology for the prediction of individual trough levels of FVIII [7]. The present communication, building on recent advances in the population pharmacokinetics (PopPK) of FVIII and FIX [8], adds to the former documents.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of thrombosis and haemostasis

ISSN

1538-7933

e-ISSN

—

Svazek periodika

15

Číslo periodika v rámci svazku

12

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

5

Strana od-do

2461-2465

Kód UT WoS článku

000417211100022

EID výsledku v databázi Scopus

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