Microsampling in pediatric studies : pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies
Background: Managing blood volumes in pediatric studies is challenging and should be minimized where possible. Results: A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was validated and implemented across two phase III global pediatric trials. Two 10-μl aliquots of blood were collected at each time point using the Mitra® device. Concordance between plasma and dried blood was established from older pediatric patients. Incurred sample reanalysis was performed in both studies using the second Mitra tip and acceptance was greater than 83%. Conclusion: The use of microsampling to generate pharmacokinetic data in 2-18-year-old pediatric patients was successfully implemented. Positive feedback was received from clinical sites about the microsampling technique assisting with enrollment of pediatric patients.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:15 |
|---|---|
| Enthalten in: |
Bioanalysis - 15(2023), 11 vom: 26. Juni, Seite 621-636 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Wickremsinhe, Enaksha R [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Baricitinib |
|---|
| Anmerkungen: |
Date Completed 06.07.2023 Date Revised 06.07.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.4155/bio-2023-0044 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM357955676 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM357955676 | ||
| 003 | DE-627 | ||
| 005 | 20231226073718.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.4155/bio-2023-0044 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1193.xml |
| 035 | |a (DE-627)NLM357955676 | ||
| 035 | |a (NLM)37293791 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Wickremsinhe, Enaksha R |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Microsampling in pediatric studies |b pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 06.07.2023 | ||
| 500 | |a Date Revised 06.07.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background: Managing blood volumes in pediatric studies is challenging and should be minimized where possible. Results: A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was validated and implemented across two phase III global pediatric trials. Two 10-μl aliquots of blood were collected at each time point using the Mitra® device. Concordance between plasma and dried blood was established from older pediatric patients. Incurred sample reanalysis was performed in both studies using the second Mitra tip and acceptance was greater than 83%. Conclusion: The use of microsampling to generate pharmacokinetic data in 2-18-year-old pediatric patients was successfully implemented. Positive feedback was received from clinical sites about the microsampling technique assisting with enrollment of pediatric patients | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Mitra® | |
| 650 | 4 | |a VAMs | |
| 650 | 4 | |a clinical sample analysis | |
| 650 | 4 | |a concordance | |
| 650 | 4 | |a dried blood | |
| 650 | 4 | |a pediatric trials | |
| 650 | 7 | |a baricitinib |2 NLM | |
| 650 | 7 | |a ISP4442I3Y |2 NLM | |
| 700 | 1 | |a Decker, Rodney L |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Lisa B |e verfasserin |4 aut | |
| 700 | 1 | |a Lelle, Erica |e verfasserin |4 aut | |
| 700 | 1 | |a Carlton, Lena A |e verfasserin |4 aut | |
| 700 | 1 | |a Keller, Stuart Y |e verfasserin |4 aut | |
| 700 | 1 | |a Prakash, Apurva |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Bioanalysis |d 2009 |g 15(2023), 11 vom: 26. Juni, Seite 621-636 |w (DE-627)NLM196969840 |x 1757-6199 |7 nnns |
| 773 | 1 | 8 | |g volume:15 |g year:2023 |g number:11 |g day:26 |g month:06 |g pages:621-636 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.4155/bio-2023-0044 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 15 |j 2023 |e 11 |b 26 |c 06 |h 621-636 | ||