New bioanalytical technologies and concepts: worth the fuss?

Abstract

BioanalysisVol. 5, No. 16 CommentaryNew bioanalytical technologies and concepts: worth the fuss?Dennis A SmithDennis A Smith4 The Maltings, Walmer, Kent, CT14 7AR, UK. Search for more papers by this authorEmail the corresponding author at professordennis@deltic50.freeserve.co.ukPublished Online:13 Aug 2013https://doi.org/10.4155/bio.13.151AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: H-bondingintracellular concentrationmembrane permeabilitymetabolite standardsreactive metabolitesPapers of special note have been highlighted as: ▪ of interestReferences1 IARC. Monographs on the evaluation of the carcinogenic risk of chemicals to man. Geneva: WHO, International Agency for Research on Cancer, 1987. http://monographs.iarc.fr/index.phpGoogle Scholar2 Walker GS, Ryder TF, Sharma R et al. Validation of isolated metabolites from drug metabolism studies as analytical standards by quantitative NMR. Drug Met. Disp.39(3),433–440 (2011).▪ Combined analytical methodology to obviate costly and difficult synthesis of metabolite standards.Crossref, Medline, CAS, Google Scholar3 Espina R, Yu L, Wang J et al. Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentrations of biologically produced metabolites: implications in metabolites in safety testing. Chem. Res. Toxicol.22(2),299–310 (2009).Crossref, Medline, CAS, Google Scholar4 Whitaker P, Meng X, Lavergne SN et al. Mass spectrometric characterization of circulating and functional antigens derived from piperacillin in patients with cystic fibrosis. J. Immunol.187(1),200–211 (2011).Crossref, Medline, CAS, Google Scholar5 El-Ghaiesh S, Monshi MM, Whitaker P et al. Characterization of the antigen specificity of t-cell clones from piperacillin-hypersensitive patients with cystic fibrosis. J. Pharm. Exper. Therap.341(3),597–610 (2012).Crossref, Medline, CAS, Google Scholar6 Amidon GL, Lennernas H, Shah V et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res.2(3),213–220 (1995).Google Scholar7 Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm. Res.22(1),11–23 (2005).▪ Rationale for the absorption, distribution, metabolism and excretion properties.Crossref, Medline, CAS, Google Scholar8 Chen M-L, Amidon GL, Benet LZ et al. The BCS, BDDCS and regulatory guidance. Pharm. Res.28(7),1774–1177 (2011).Crossref, Medline, CAS, Google Scholar9 Alex A, Millan DS, Perez M et al. Intramolecular hydrogen bonding to improve membrane permeability and absorption in beyond rule of five chemical space. Med. Chem. Commun.2(7),669–674 (2011).Crossref, CAS, Google Scholar10 Rafi SB, Hearn BR, Vedantham P et al. Predicting and improving the membrane permeability of peptidic small molecules. J. Med. Chem.55(7),3163–3169 (2012).Crossref, Medline, CAS, Google Scholar11 Smith DA. Does validation stagnate innovation. Bioanalysis2(8),1349–1350 (2010).Link, CAS, Google Scholar12 Vallet CM, Marquez B, Ngabirano E et al. Cellular accumulation of fluoroquinolones is not predictive of their intracellular activity: studies with gemifloxacin, moxifloxacin and ciprofloxacin in a pharmacokinetic/pharmacodynamic model of uninfected and infected macrophages. Int. J. Antimicrob. Agents38(3),249–256 (2011).Medline, CAS, Google Scholar13 Smith DA. The debate is over: accelerator MS provides the route to better drug development protocols/paradigms. Bioanalysis3(4),407–410 (2011).Link, Google Scholar14 Obach RS, Nedderman AN, Smith DA. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary? Xenobiotica42(1),46–56 (2012).▪ Suggests alternative approaches to in vivo absorption, distribution, metabolism and excretion studies, challenging the existing protocols used for approximately four decades.Crossref, Medline, CAS, Google ScholarFiguresReferencesRelatedDetails Vol. 5, No. 16 Follow us on social media for the latest updates Metrics Downloaded 180 times History Published online 13 August 2013 Published in print August 2013 Information© Future Science LtdKeywordsH-bondingintracellular concentrationmembrane permeabilitymetabolite standardsreactive metabolitesFinancial & competing interests disclosureD Smith has a number of advisory and academic roles with partners including Xceleron. The thoughts on Accelerator MS in this paper were published prior to any connection with the company. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download