Evaluation of two blood microsampling approaches for drug discovery PK studies in rats

被引:25
作者
Luo, Yongyi [1 ]
Korfmacher, Walter [1 ]
Ho, Stacy [1 ]
Shen, Liduo [1 ]
Wang, Jie [1 ]
Wu, Zhongtao [1 ]
Guo, Yang [1 ]
Snow, Gregory [2 ]
O'Shea, Thomas [1 ]
机构
[1] Drug Metab & Pharmacokinet Sanofi, Waltham, MA 02451 USA
[2] Agilux, Worcester, MA 01605 USA
关键词
QUANTITATIVE BIOANALYSIS; PLASMA; SAMPLES; HEMATOCRIT; VALIDATION;
D O I
10.4155/bio.15.126
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Background: Serial sampling in discovery rat PK studies could be performed via capillary microsampling (CMS) of blood or by using the Mitra device to collect dried blood samples. Results: Blood CMS results were compared with Mitra sampling results for four test compounds dosed in rat PK studies. The PK profiles obtained from CMS sampling were found to be very similar to those obtained from the Mitra sampling. For 15-mu l blood CMS samples, freezing before the dilution step was found to be acceptable. Conclusion: Blood CMS using 15-mu l glass capillary microsamples works well for serial blood sampling in rat PK studies. The Mitra microsampling device provides an alternative method for collecting 10 mu l of blood as a dried blood sample.
引用
收藏
页码:2345 / 2359
页数:15
相关论文
共 20 条
[1]   Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies [J].
Chapman, Kathryn ;
Chivers, Simon ;
Gliddon, Dan ;
Mitchell, David ;
Robinson, Sally ;
Sangster, Tim ;
Sparrow, Susan ;
Spooner, Neil ;
Wilson, Amanda .
DRUG DISCOVERY TODAY, 2014, 19 (05) :528-532
[2]   The effect of hematocrit on bioanalysis of DBS: results from the EBF DBS-microsampling consortium [J].
de Vries, Ronald ;
Barfield, Matthew ;
van de Merbel, Nico ;
Schmid, Bernhard ;
Siethoff, Christoph ;
Ortiz, Jordi ;
Verheij, Elwin ;
van Baar, Ben ;
Cobb, Zoe ;
White, Steve ;
Timmerman, Philip .
BIOANALYSIS, 2013, 5 (17) :2147-2160
[3]   Quantitative bioanalysis of paracetamol in rats using volumetric absorptive microsampling (VAMS) [J].
Denniff, Philip ;
Parry, Simon ;
Dopson, Wesley ;
Spooner, Neil .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2015, 108 :61-69
[4]   Volumetric Absorptive Microsampling: A Dried Sample Collection Technique for Quantitative Bioanalysis [J].
Denniff, Philip ;
Spooner, Neil .
ANALYTICAL CHEMISTRY, 2014, 86 (16) :8489-8495
[5]   The effect of hematocrit on assay bias when using DBS samples for the quantitative bioanalysis of drugs [J].
Denniff, Philip ;
Spooner, Neil .
BIOANALYSIS, 2010, 2 (08) :1385-1395
[6]   A good practice guide to the administration of substances and removal of blood, including routes and volumes [J].
Diehl, KH ;
Hull, R ;
Morton, D ;
Pfister, R ;
Rabemampianina, Y ;
Smith, D ;
Vidal, JM ;
van de Vorstenbosch, C .
JOURNAL OF APPLIED TOXICOLOGY, 2001, 21 (01) :15-23
[7]  
Dillen L, 2014, BIOANALYSIS, V6, P293, DOI [10.4155/BIO.13.286, 10.4155/bio.13.286]
[8]  
Hui Yu-Hua, 2007, Journal of Pharmacological and Toxicological Methods, V56, P256, DOI 10.1016/j.vascn.2007.05.006
[9]  
Jonsson O, 2013, BIOANALYSIS, V5, P449, DOI [10.4155/BIO.12.337, 10.4155/bio.12.337]
[10]  
Jonsson O, 2012, BIOANALYSIS, V4, P1989, DOI [10.4155/BIO.12.177, 10.4155/bio.12.177]