1,672
Views
0
CrossRef citations to date
0
Altmetric
Foreword

Novel LC–MS Assays Impacting CYP and Transporter Drug–Drug Interaction Evaluations

Pages 609-613 | Received 26 Mar 2018, Accepted 28 Mar 2018, Published online: 29 May 2018

References

  • US FDA . In Vitro Metabolism- and Transporter-Mediated Drug–Drug Interaction Studies. Guidance for Industry (2017). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581965.pdf.
  • US FDA . FDA (2010) Guidance for Industry M3(R2). Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (2010). www.fda.gov/downloads/drugs/guidances/ucm073246.pdf.
  • Tweedie D , PolliJW, BerglundEGet al. Transporter studies in drug development: experience to date and follow-up on decision trees from the International Transporter Consortium. Clin. Pharmacol. Ther.94 (1), 113–125 (2013).
  • Ronaldson PT , BauerB, El-KattanAF, ShenH, SalphatiL, LouieSW. Highlights from the American Association of Pharmaceutical Scientists/International Transporter Consortium Joint Workshop on drug transporters in absorption, distribution, metabolism, and excretion: from the bench to the bedside – clinical pharmacology considerations. Clin. Pharmacol. Ther.100 (5), 419–422 (2016).
  • Huang SM , ZhangL, GiacominiKM. The International Transporter Consortium: a collaborative group of scientists from academia, industry, and the FDA. Clin. Pharmacol. Ther.87 (1), 32–36 (2010).
  • Rendic S . Summary of information on human CYP enzymes: human P450 metabolism data. Drug Metab. Rev.34 (1–2), 83–448 (2002).
  • Rendic S , GuengerichFP. Update information on drug metabolism systems--2009, part II: summary of information on the effects of diseases and environmental factors on human cytochrome P450 (CYP) enzymes and transporters. Curr. Drug Metab.11 (1), 4–84 (2010).
  • Yu J , ZhouZ, Tay-SontheimerJ, LevyRH, Ragueneau-MajlessiI. Risk of clinically relevant pharmacokinetic-based drug-drug interactions with drugs approved by the U.S. Food and drug administration between 2013 and 2016. Drug Metab. Dispos. doi:10.1124/dmd.117.078691 (2018) ( Epub ahead of print).
  • Yan Z , CaldwellGW. The current status of time dependent CYP inhibition assay and in silico drug-drug interaction predictions. Curr. Top. Med. Chem.12 (11), 1291–1297 (2012).
  • Zientek M , YoudimK. Simultaneous determination of multiple CYP inhibition constants using a cocktail-probe approach. Methods Mol. Biol.987, 11–23 (2013).
  • Volpe DA , BalimanePV. Application of in vitro CYP and transporter assays to predict clinical drug-drug interactions. Bioanalysis10 (9), 619–623 (2018).
  • Ramanathan R , MckenzieDL, TugnaitM, SiebenalerK. Application of semi-automated metabolite identification software in the drug discovery process for rapid identification of metabolites and the cytochrome P450 enzymes responsible for their formation. J. Pharm. Biomed. Anal.28 (5), 945–951 (2002).
  • Nielsen LM , HolmNB, Leth-PetersenS, KristensenJL, OlsenL, LinnetK. Characterization of the hepatic cytochrome P450 enzymes involved in the metabolism of 25I-NBOMe and 25I-NBOH. Drug Test. Anal.9 (5), 671–679 (2017).
  • Zhang L , ReynoldsKS, ZhaoP, HuangSM. Drug interactions evaluation: an integrated part of risk assessment of therapeutics. Toxicol. Appl. Pharmacol.243 (2), 134–145 (2010).
  • Huang SM , TempleR, ThrockmortonDC, LeskoLJ. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin. Pharmacol. Ther.81 (2), 298–304 (2007).
  • Ramanathan R , GhosalA, RamanathanL, ComstockK, ShenH, RamanathanDM. HPLC-HRMS with polarity switching for increasing throughput of human in vitro cocktail drug-drug interaction assay. Bioanalysis10 (9), 677–690 (2018).
  • Vaidyanathan J , YoshidaK, AryaV, ZhangL. Comparing various in vitro prediction criteria to assess the potential of a new molecular entity to inhibit organic anion transporting polypeptide 1B1. J. Clin. Pharmacol.56 (Suppl. 7), S59–S72 (2016).
  • Tsuruya Y , KatoK, SanoYet al. Investigation of endogenous compounds applicable to drug-drug interaction studies involving the renal organic anion transporters, OAT1 and OAT3, in humans. Drug Metab. Dispos.44 (12), 1925–1933 (2016).
  • Rodrigues AD , TaskarKS, KusuharaH, SugiyamaY. Endogenous probes for drug transporters: balancing vision with reality. Clin. Pharmacol. Ther.103 (3), 434–448 (2017).
  • Ito S , KusuharaH, KumagaiYet al. N-methylnicotinamide is an endogenous probe for evaluation of drug-drug interactions involving multidrug and toxin extrusions (MATE1 and MATE2-K). Clin. Pharmacol. Ther.92 (5), 635–641 (2012).
  • Lee SC , AryaV, YangX, VolpeDA, ZhangL. Evaluation of transporters in drug development: Current status and contemporary issues. Adv. Drug Deliv. Rev.116, 100–118 (2017).
  • Rodrigues AD . Endogenous probes for human liver organic anion transporting polypeptides (OATPs): the Intersection of Bioanalytical and ADME science. Bioanalysis10 (9), 615–618 (2018).
  • Shen H . A pharmaceutical industry perspective on transporter and CYP mediated drug-drug interactions: kidney transporter biomarkers. Bioanalysis10 (9), 625–631 (2018).
  • Abe K , KonakaR. Quantification of urinary porphyrins by liquid chromatography after oxidation of porphyrinogens. Clin. Chem.35 (8), 1619–1622 (1989).
  • Bozek P , HuttaM, HrivnakovaB. Rapid analysis of porphyrins at low ng/l and microg/l levels in human urine by a gradient liquid chromatography method using octadecylsilica monolithic columns. J. Chromatogr. A1084 (1–2), 24–32 (2005).
  • Respaud R , Benz-De BretagneI, BlascoH, HulotJS, LechatP, Le GuellecC. Quantification of coproporphyrin isomers I and III in urine by HPLC and determination of their ratio for investigations of multidrug resistance protein 2 (MRP2) function in humans. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.877 (30), 3893–3898 (2009).
  • Jacob K , DossMO. Composition of urinary coproporphyrin isomers I-IV in human porphyrias. Eur. J. Clin. Chem. Clin. Biochem.31 (10), 617–624 (1993).
  • Jacob K , EgelerE, GrossU, DossMO. Investigations on the formation of urinary coproporphyrin isomers I-IV in 5-aminolevulinic acid dehydratase deficiency porphyria, acute lead intoxication and after oral 5-aminolevulinic acid loading. Clin. Biochem.32 (2), 119–123 (1999).
  • To-Figueras J , OzallaD, MateuCH. Long-standing changes in the urinary profile of porphyrin isomers after clinical remission of porphyria cutanea tarda. Ann. Clin. Lab. Sci.33 (3), 251–256 (2003).
  • Cohen C , KirschRE, MooreMR. Porphobilinogen deaminase and the synthesis of porphyrin isomers in the Dubin-Johnson syndrome. S. Afr. Med. J.70 (1), 36–39 (1986).
  • Ramanathan R , King-AhmadAJ, HollimanCL, RodriguesAD. A highly selective and sensitive LC-MS/HRMS assay for quantifying coproporphyrins as organic anion-transporting peptide biomarkers. Bioanalysis9 (22), 1787–1806 (2017).
  • Shen H , DaiJ, LiuTet al. Coproporphyrins I and III as functional markers of OATP1B activity: in vitro and in vivo evaluation in preclinical species. J. Pharmacol. Exp. Ther.357 (2), 382–393 (2016).
  • Bednarczyk D , BoiselleC. Organic anion transporting polypeptide (OATP)-mediated transport of coproporphyrins I and III. Xenobiotica46 (5), 457–466 (2016).
  • Shen H , SuH, LiuTet al. Evaluation of rosuvastatin as an organic anion transporting polypeptide (OATP) probe substrate: in vitro transport and in vivo disposition in cynomolgus monkeys. J. Pharmacol. Exp. Ther.353 (2), 380–391 (2015).
  • Rodrigues AC , PerinPM, PurimSGet al. Pharmacogenetics of OATP transporters reveals that SLCO1B1 c.388A>G variant is determinant of increased atorvastatin response. Int. J. Mol. Sci.12 (9), 5815–5827 (2011).
  • Njumbe Ediage E , DillenL, VromanAet al. Development of an LC–MS method to quantify coproporphyrin I and III as endogenous biomarkers for drug transporter-mediated drug–drug interactions. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.1073, 80–89 (2018).
  • King-Ahmad A , ClemensS, RamanathanRet al. A fully automated and validated human plasma LC–MS/MS assay for endogenous OATP biomarkers coproporphyrin-I and coproporphyrin III. Bioanalysis10 (9), 665–675 (2018).
  • Kandoussi H , ZengJ, ShahKet al. UHPLC–MS/MS bioanalysis of human plasma coproporphyrins as potential biomarkers for OATP-mediated drug interactions. Bioanalysis10 (9), 691–702 (2018).
  • Mazzacuva F , MillsP, MillsKet al. Identification of novel bile acids as biomarkers for the early diagnosis of Niemann-Pick C disease. FEBS Lett.590 (11), 1651–1662 (2016).
  • Rago B , TierneyB, RodriguesD, HollimanC, RamanathanR. A multiplex HRMS assay for quantifying selected human plasma bile acids as candidate OATP biomarkers. Bioanalysis10 (9), 633–645 (2018).
  • Luo L , KayJ, ZhangYet al. LC–MS/MS assay for N1-methylnicotinamide in humans, an endogenous probe for renal transporters. Bioanalysis10 (9), 673–689 (2018).
  • Ramanathan R , JosephsJL, JemalM, ArnoldM, HumphreysWG. Novel MS solutions inspired by MIST. Bioanalysis2 (7), 1291–1313 (2010).
  • Takahashi RH , KhojastehC, WrightM, HopC, MaS. Mixed matrix method provides a reliable metabolite exposure comparison for assessment of metabolites in safety testing (MIST). Drug Metab. Lett.11 (1), 21–28 (2017).

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.