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@article{1774697, author = {Blanchette, V. S. and Zunino, L. and Grassmann, V. and Barnes, C. and Carcao, M. D. and Curtin, J. and Jackson, S. and Khoo, L. and Komrska, Vladimir and Lillicrap, D. and Morfini, M. and Romanová, Gabriela and Stephens, D. and Zapotocka, Ester and Rand, M. L. and Blatný, Jan}, article_location = {STUTTGART}, article_number = {10}, doi = {http://dx.doi.org/10.1055/a-1376-0970}, keywords = {factor VIII; hemophilia A; pharmacokinetic; observational study; population PK}, language = {eng}, issn = {0340-6245}, journal = {THROMBOSIS AND HAEMOSTASIS}, title = {A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects}, url = {https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1376-0970}, volume = {121}, year = {2021} }
TY - JOUR ID - 1774697 AU - Blanchette, V. S. - Zunino, L. - Grassmann, V. - Barnes, C. - Carcao, M. D. - Curtin, J. - Jackson, S. - Khoo, L. - Komrska, Vladimir - Lillicrap, D. - Morfini, M. - Romanová, Gabriela - Stephens, D. - Zapotocka, Ester - Rand, M. L. - Blatný, Jan PY - 2021 TI - A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects JF - THROMBOSIS AND HAEMOSTASIS VL - 121 IS - 10 SP - 1326-1336 EP - 1326-1336 PB - GEORG THIEME VERLAG KG SN - 03406245 KW - factor VIII KW - hemophilia A KW - pharmacokinetic KW - observational study KW - population PK UR - https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1376-0970 N2 - Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72-hour washout and 5 to 11 timed blood samples. A no-washout, single-clinic visit, sparse sampling population PK (PPK) protocol is an attractive alternative. Here, we compared PK parameters obtained with a traditional washout, 6-sampling time point PPK protocol with a no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol in persons with severe hemophilia A (SHA) receiving ADVATE. A total of 39 inhibitor-negative males with SHA (factor VIII activity [FVIII:C]<2%) were enrolled in a prospective sequential design PK study. Participants completed a washout, 6-sampling time point PPK protocol as well as a no-washout, reverse 2-sampling time point protocol, with samples taken during a single 3-hour clinic visit 24hours post home infusion of FVIII and then 3hours post infusion in clinic. FVIII:C levels were analyzed by one-stage and chromogenic assays; blood group and von Willebrand factor antigen (VWF:Ag) were determined; and PK parameters were analyzed using the ADVATE myPKFiT dosing tool. There was moderate to almost perfect agreement for the PK parameters obtained with the 2- and the 6- point PPK protocols using a one-stage FVIII:C assay and a substantial to almost perfect agreement using a chromogenic FVIII:C assay. Significant associations between specific PK parameters and blood group and VWF:Ag were observed. The no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol can be used in the routine clinical setting since it demonstrates sufficient accuracy compared with the more demanding and less practical washout, 6-sampling time point PPK protocol in persons with SHA receiving ADVATE. ER -
BLANCHETTE, V. S., L. ZUNINO, V. GRASSMANN, C. BARNES, M. D. CARCAO, J. CURTIN, S. JACKSON, L. KHOO, Vladimir KOMRSKA, D. LILLICRAP, M. MORFINI, Gabriela ROMANOVÁ, D. STEPHENS, Ester ZAPOTOCKA, M. L. RAND a Jan BLATNÝ. A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects. \textit{THROMBOSIS AND HAEMOSTASIS}. STUTTGART: GEORG THIEME VERLAG KG, 2021, roč.~121, č.~10, s.~1326-1336. ISSN~0340-6245. Dostupné z: https://dx.doi.org/10.1055/a-1376-0970.
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