211
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Discovery Bioanalysis and In Vivo Pharmacology as an Integrated Process: A Case Study in Oncology Drug Discovery

, , , , &
Pages 1481-1498 | Received 16 Mar 2016, Accepted 01 Jun 2016, Published online: 17 Jun 2016

References

  • Korfmacher W . Principles and application of LC–MS in new drug discovery. Drug Discov. Today10 (20), 1357–1367 (2005).
  • Smith D . A new phase of drug discovery? The rise of PK/PD means extremely challenging work at the coalface. Bioanalysis7 (12), 1415–1417 (2015).
  • Dudal S , StaackR, StoellnerDet al. How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics: a reflection of the European Bioanalysis Forum. Bioanalysis6 (10), 1339–1348 (2014).
  • Simithy J , GillG, WangY, GoodwinD, CalderónA. Development of an ESI-LC–MS-based assay for kinetic evaluation of Mycobacterium tuberculosis shikimate kinase activity and inhibition. Anal. Chem. 87, 2129–2136 (2015).
  • Sirtori F , CaronniD, ColomboMet al. Establish an automated flow injection ESI-MS method for the screening of fragment based libraries: application to Hsp. Eur. J. Pharm. Sci. 76, 83–94 (2015).
  • Hofstadler S , Sannes-LoweryK. Applications of ESI-MS in drug discovery: interrogation of non-covalent complexes. Nat. Rev. Drug Discov. 5, 585–595 (2006).
  • Venable J , StecklerC, OuW, GrünewaldJ, AgarwallaS, BrockA. Isotope-coded labeling for accelerating protein interaction profiling using MS. Anal. Chem. 87, 7540–7544 (2015).
  • Tiller P , RomanyshynL. Liquid chromatography/tandem mass spectrometric quantification with metabolite screening as a strategy to enhance the early drug discovery process. Rapid Commun. Mass Spectrom. 16, 1225–1331 (2002).
  • Tiller P , YuS, Castro-PerezJ, FillgroveK, BaillieT. High-throughput, accurate mass liquid chromatography/tandem mass spectrometry on a quadrupole time-of-flight system as a “first-line” approach for metabolite identification studies. Rapid Commun. Mass Spectrom. 22, 1053–1061 (2008).
  • King L , KotianA, JairajM. Introduction of a routine quan/qual approach into research DMPK: experiences and evolving strategies. Bioanalysis6 (24), 3337–3348 (2014).
  • Koblish H.K , HansburyM.J, BowmanK.Jet al. Hydroxyamidine Inhibitors of Indoleamine-2,3-dioxygenase potently suppress systemic tryptophan catabolism and the growth of IDO-expressing tumors. Mol. Cancer Ther. 9 (2), 489–498 (2010).
  • Bateman K , CastonguayG, XuLet al. Reduction of animal usage by serial bleeding of mice for pharmacokinetic studies: application of robotic sample preparation and fast liquid chromatography-mass spectrometry. J. Chromatogr. B754, 245–251 (2001).
  • Beaudette P , BatemanK. Discovery stage pharmacokinetics using dried blood spots. J. Chromatogr. B809, 153–158 (2004).
  • Joyce A , WangM, Lawrence-HendersonRet al. One mouse, one pharmacokinetic profile: quantitative whole blood serial sampling for biotherapeutics. Pharm. Res. 31, 1823–1833 (2014).
  • Clark G , HaynesJ, BaylissM, BurrowsL. Utilization of DBS within drug discovery: development of a serial microsampling pharmacokinetic study in mice. Bioanalysis2 (8), 1477–1488 (2010).
  • Chapman K , ChiversS, GliddonDet al. Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies. Drug Discov. Today19 (5), 528–532 (2014).
  • Diehl K , HullR, MortonDet al. A good practice guide to the administration of substances and removal of blood, including routes and volumes. J. Appl. Toxicol. 21, 15–23 (2001).
  • Korfmacher W , FitzgeraldM, LuoYet al. Capillary microsampling of whole blood for mouse PK studies: an easy route to serial blood sampling. Bioanalysis7 (4), 449–461 (2015).
  • Swales J , TemesiD, DennM, MurphyK. Determination of paracetamol in mouse, rat and dog plasma samples by laser diode thermal desorption APCI-MS/MS. Bioanalysis4 (11), 1327–1335 (2012).
  • Wan K , ReimerM, MetchkarovaMet al. Toxicokinetic evaluation of atrasentan in mice utilizing serial microsampling: validation and sample analysis in GLP study. Bioanalysis4 (11), 1351–1361 (2012).
  • Wickremsinhe E . Dried blood spot analysis for rat and dog studies: validation, hematocrit, toxicokinetics and incurred sample reanalysis. Bioanalysis7 (7), 869–883 (2015).
  • Henry H , SobhiH, ScheibnerO, BromirskiM, NimkarS, RochatB. Comparison between a high-resolution single-stage Orbitrap and a triple quadrupole mass spectrometer for analyses of drugs. Rapid Commun. Mass Spectrom. 26, 499–509 (2012).
  • Oliveira R , HenionJ, WickremsinheE. Automated high-capacity on-line extraction and bioanalysis of dried blood spot samples using liquid chromatography/high-resolution accurate mass spectrometry. Rapid Commun. Mass Spectrom. 28, 2415–2426 (2014).
  • Oliveira RV , HenionJ, WickremsinheE. Automated direct extraction and analysis of dried blood spots employing on-line SPE high-resolution accurate mass bioanalysis. Bioanalysis6 (15), 2027–2041 (2014).
  • Dillen L , LoomansT, Van de PerreG, VersweyveldD, WuytsK, de ZwartL. Blood microsampling using capillaries for drug-exposure determination in early preclinical studies: a beneficial strategy to reduce blood sample volumes. Bioanalysis6 (3), 293–306 (2014).
  • Jonsson O , Palma VillarR, NilssonLet al. Capillary microsampling of 25μl blood for the determination of toxicokinetic parameters in regulatory studies in animals. Bioanalysis4 (6), 661–674 (2012).
  • Caron A , LelongC, PascualMH, BenningV. Miniaturized blood sampling techniques to benefit reduction in mice and refinement in nonhuman primates: applications to bioanalysis in toxicity studies with antibody–drug conjugates. J. Am. Assoc. Lab. Animal54 (2), 145–152 (2015).
  • Ahmad S , TuckerM, SpoonerN, MurnaneD, GerhardU. Direct Ionization of solid-phase microextraction fibers for quantitative drug bioanalysis: from peripheral circulation to mass spectrometry detection. Anal. Chem. 87, 754–759 (2015).
  • Takyi-Williams J , DongX, GongHet al. Application of paper spray-MS in PK studies using sunitinib and benzethonium as model compounds. Bioanalysis7 (4), 413–423 (2015).
  • Zhang C , ManickeN. Development of a paper spray mass spectrometry cartridge with integrated solid phase extraction for bioanalysis. Anal. Chem. 87, 6212–6219 (2015).
  • Picard P , AugerS, TremblayP, AuthorR. Speeding up the dry blood spot, plasma, urine and saliva with a new sampling technology using a one-step extractions combined with LDTD-MS/MS analysis. Presented at : 59th Conference on Mass Spectrometry and Allied Topics. Denver, CO, USA, 5–9 June 2011.
  • Crawford E , GordonJ, WuJT, MusselmanB, LiuR, YuS. Direct analysis in real time coupled with dried spot sampling for bioanalysis in a drug-discovery setting. Bioanalysis3 (11), 1217–1226 (2011).
  • Wiseman J , EvansC, BowenC, KennedyJ. Direct analysis of dried blood spot utilizing desorption electrospray ionization (DESI). mass spectrometry. Analyst135, 720–725 (2010).
  • Vuckovic D , de LannoyI, GienBet al. In vivo solid-phase microextraction for single rodent pharmacokinetics studies of carbamazepine and carbamazepine-10,11-epoxide in mice. J. Chromatogr. A1218, 3367–3375 (2011).
  • Vuckovic D , de LannoyI, GienBet al. In vivo solid-phase microextraction: capturing the elusive portion of metabolome. Angew. Chem. Int. Ed. Engl. 50, 5344–5348 (2011).
  • Donabella P , RogersN, LevinR, MusteataF. Development of supported liquid-phase microextraction probes for in vivo PK studies. Bioanalysis7 (6), 661–670 (2015).
  • Li W , TseF. Dried blood spot sampling in combination with LC–MS/MS for quantitative analysis of small molecules. Biomed. Chromatogr. 24, 49–65 (2010).
  • Wagner M , TonoliD, VaresioE, HopfgartnerG. The use of mass spectrometry to analyze dried blood spots. Mass Spectrom. Rev. 35, 361–438 (2016).
  • Guthrie R , SusiA. A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants. Pediatrics338–343 (1963).
  • Chace D , KalasT, NaylorE. The application of tandem mass spectrometry to neonatal screening for inherited disorders of intermediary metabolism. Annu. Rev. Genomics Hum. Genet. 3, 17–45 (2002).
  • Cipriano L , RuparA, ZaricG. The cost-effectiveness of expanding newborn screening for up to 21 inherited metabolic disorders using tandem mass spectrometry: results from a decision-analytic model. Value Health10 (2), 83–97 (2007).
  • Rousseau F , GiguèreY, BerthierMT, GuéretteD, GirardJG, DéryM. Newborn screening by tandem mass spectrometry: impacts, implication and perspectives. In : Tandem Mass Spectrometry – Application and Principles. PrasainJ ( Ed.). Intech Europe, Rijeka, Croatia, 751–776 (2012).
  • Meesters R , HooffG. State-of-the-art dried blood spot analysis: an overview of recent advances and future trends. Bioanalysis5 (17), 2187–2208 (2013).
  • Stove C , IngelsAS, De KeselP, LambertW. Dried blood spots in toxicology: from the cradle to the grave?Crit. Rev. Toxicol. 42 (3), 230–243 (2012).
  • Spooner N , DenniffP. Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis. Anal. Chem. 86, 8489–8495 (2014).
  • Spooner N , DenniffP, MichielsenLet al. A device for dried blood microsampling in quantitative bioanalysis: overcoming the issues associated with blood hematocrit. Bioanalysis7 (6), 653–659 (2015).
  • Luo Y , KorfmacherW, HoSet al. Evaluation of two blood microsampling approaches for drug discovery PK studies in rats. Bioanalysis7 (18), 2345–2359 (2015).
  • Zhang Y , HuoM, ZhouJ, XieS. PKSolver: an add-in program for pharmacokinetic and pharmacodynamic data in Microsoft Excel. Compt. Methods Programs Biomed. 99, 306–314 (2010).
  • Gao H , HoS, WilliamsJ. LC–MS Bioanalysis of drugs in tissue samples. In : Handbook of LCMS Bioanalysis; Best Practices, Experimental Protocols, and Regulations. LiW, ZhangJ, TseF ( Eds). John Wiley and Sons, NJ, USA, 297–306 (2013).
  • Workman P , AboagyeEO, BalkwillFet al. Guidelines for the welfare and use of animals in cancer research. Br. J. Cancer102 (11), 1555–1577 (2010).
  • Kruczynski A , PillonA, CréancierLet al. F14512, a polyamine-vectorized anti-cancer drug, currently in clinical trials exhibits a marked preclinical anti-leukemic activity. Leukemia27 (11), 2139–2148 (2013).
  • Rahavendran S , VekichS, SkorHet al. Discovery pharmacokinetic studies in mice using serial microsampling, dried blood spots and microbore LC–MS/MS. Bioanalysis4 (9), 1077–1095 (2012).
  • Li F , PlochS, FastDet al. Perforated dried blood spot accurate microsampling: the concept and its applications in toxicokinetic sample collection. J. Mass. Spectrom. 47, 655–667 (2012).
  • Meesters RJW , ZhangJ, Van HuizenNAet al. Dried matrix on paper disks: the next generation DBS microsampling technique for managing the hematocrit effect in DBS analysis. Bioanalysis4 (16), 2027–2035 (2012).
  • Ji Ji A et al. A novel approach for quantitation of glucosylceramide in human dried blood spot using LC–MS/MS. Bioanalysis7 (12), 1483–1496 (2015).
  • Leuthold LA et al. New microfluidic-based sampling procedure for overcoming the hematocrit problem associated with dried blood spot analysis. Anal. Chem. 87, 2068–2071 (2015).
  • Shou W . Discovery bioanalysis. Bioanalysis4 (9), 983–984 (2012).
  • Xie C , ZhongD, YuK, ChenX. Recent advances in metabolite identification and quantitative bioanalysis by LC-Q-TOF MS. Bioanalysis4 (8), 937–959 (2012).
  • Morin LP , MessJN, GarofoloF. Large-molecule quantification: sensitivity and selectivity head-to-head comparison of triple quadrupole with Q-TOF. Bioanalysis5 (10), 1181–1193 (2013).
  • Gómez-Canela C , Cortés-FranciscoN, VenturaF, CaixachJ, LacorteS. Liquid chromatography coupled to tandem mass spectrometry and high resolution mass spectrometry as analytical tools to characterize multi-class cytostatic compounds. J. Chromatogr A1276, 78–94 (2013).
  • Backfisch G , Reder-HilzB, Hoeckels-MessemerJet al. High-throughput quantitative and qualitative analysis of microsomal incubations by cocktail analysis with an ultraperformance liquid chromatography-quadrupole time-of-flight mass spectrometer system. Bioanalysis7 (6), 671–683 (2015).
  • Balani S , LiP, NguyenJet al. Effective dosing regimen of 1-aminobenzotriazole for inhibiting of antipyrine clearance in guinea pigs and mice using serial sampling. Drug Metabol. Dispos. 32 (10), 1092–1095 (2004).
  • Yamazaki S , ViciniP, ZhongzhouSet al. Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models. J. Pharmacol. Exp. Ther. 340 (3), 549–557 (2012).
  • Nam S , WilliamsA, VulturAet al. Dasatinib (BMS-354825). inhibits Stat5 signaling associated with apoptosis in chronic myelogenous leukemia cells. Mol. Cancer Ther. 6 (4), 1400–1405 (2007).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.