Advanced search
Publication Cover
Bioanalysis Volume 6, 2014 - Issue 5
Submit an article Journal homepage
23,348
Views
4
CrossRef citations to date
0
Altmetric
Mini Focus Issue: Tiered approach to bioanalysis - White Paper

Bioanalysis for Plasma Protein Binding Studies in Drug Discovery and Drug Development: Views and Recommendations of The European Bioanalysis Forum

Brigitte Buscher1 TNO Triskelion BV, Utrechtseweg 48, 3704HEZeist, The Netherlands. [email protected]Correspondence[email protected]
,
Sirpa Laakso2 Orion Corporation, ORION PHARMA, Orionintie 1A, 02200Espoo, Finland
,
Hermann Mascher3 Pharm-analyt, Ferdinand-Pichler-Gasse 2, 2500Baden, Austria
,
Klaus Pusecker4 Grünenthal GmbH, Zieglerstr. 6, D-52078Aaachen, Germany
,
Mira Doig5 ABS Laboratories Ltd, BioPark, Broadwater Road, Welwyn Garden City, AL7 3AX, UK
,
Lieve Dillen6 Janssen R&D, Turnhoutseweg 30, 2340Beerse, Belgium
,
Winfried Wagner-Redeker7 Swiss BioAnalytics AG, Sternenfeldstrasse 14, 4127Birsfelden, Switzerland
,
Thomas Pfeifer8 Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123Allschwil, Switzerland
,
Pascal Delrat9 Technologie Servier, 25/27 Rue Eugène Vignat, 45000Orléans, France
&
Philip Timmerman6 Janssen R&D, Turnhoutseweg 30, 2340Beerse, Belgium
 show all
Pages 673-682 | Published online: 12 Mar 2014

References

  • Fichtl B , NiecieckiA, WalterK. Tissue binding versus plasma binding of drugs: general principles and pharmacokinetic consequences. Adv. Drug Res. 20, 118–166 (1991).
  • Levitt DG . PKQuest: capillary permeability limitation and plasma protein binding – application to humen inulin, dicloxacillin and ceftriaxone pharmacokinetics. BMC Clin. Pharmacol. 2, 7 (2002).
  • Bohnert T , Gan L-S. Plasma protein binding: from discovery to development. J. Pharm. Sci. 102(9), 2953–2994 (2013).
  • Trainor GL . The importance of plasma protein binding in drug discovery. Expert Opin. Drug Discov. 2(1), 51–64 (2007).
  • European Medicines Agency. ICH Guideline M3(R2) on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals. EMA/CPMP/ICH/286/1995. European Medicines Agency, London, UK (2009).
  • European Medicines Agency, Committee for Human Medicinal Products. Guideline on the Investigation of Drug Interactions, Final. CPMP/EWP/560/95/Rev. 1 Corr.*. European Medicines Agency, London, UK (2012).
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research Guidance for Industry, Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations. Draft Guidance . FDA, Rockville, MD, USA (2012).
  • Proost JH , WierdaJMKH, MeijerDKF. An extended pharmacokinetic/pharmacodynamic model describing quantitatively the influence of plasma protein binding, tissue binding and receptor binding on the potency and time course of action of drugs. J. Pharmacokinet. Biopharm. 24(1), 45–77 (1996).
  • Bekersky I , FieldingRM, DresslerDEet al. Plasma protein binding of amphotericin B and pharmacokinetics of bound versus unbound amphotericin B after administration of intravenous liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate. Antimicrob. Agents Chemother. 46(3), 834–840 (2002).
  • European Medicines Agency, Committee for Medicinal Products for Human Use. Note for Guidance on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Renal Function, CHMP/EWP/225/02. European Medicines Agency, London, UK (2004).
  • European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function, CPMP/EWP/2339/02. European Medicines Agency, London, UK (2005).
  • Benet LZ , OieS, SchwartzJB. Design and optimization of dosage regimens; pharmacokinetic data. In: Goodman and Gilman’s The Pharmacological Basis of Therapeutics (9th Edition). McGraw-Hill, NY, USA, 1707–1711 (1996).
  • Mullangi R , SrinivasNR. Clopidogrel: review of bioanalytical methods, pharmacokinetics/pharmacodynamics, and update on recent trends in drug-drug interaction studies. Biomed. Chromatogr. 23(1), 26–41 (2008).
  • Sousa M , PozniakA, BoffitoM. Pharmacokinetics and pharmacodynamics of drug interactions involving rifampicin, rifabutin and antimalarial drugs. J. Antimicrob. Chemother. 62(5), 872–878 (2008).
  • Wada M , IkedaR, NakashimaK. Microdialysis in drug-drug interactions. In: Applications of Microdialysis in Pharmaceutical Science. John Wiley & Sons, Inc., NJ, USA, 465–507 (2011).
  • Zhao Z , XueF, ZhangLet al. The pharmacokinetics of nitazoxanide active metabolite (tizoxanide) in goats and its protein binding ability in vitro. J. Vet. Pharmacol. Ther. 33(2), 147–153 (2010).
  • Drayer DE , LorenzoB, WernsSet al. Plasma levels, protein binding, and elimination data of lidocaine and active metabolites in cardiac patients of various ages. Clin. Pharmacol. Ther. 34(1), 14–22 (1983).
  • Bowers WF , FultonS, ThompsonJ. Ultrafiltration vs. equilibrium dialysis for determination of free fraction. Clin. Pharmacokinet. 9(1), 49–60 (1984).
  • Lee KJ , MowerR, HollenberckTet al. Modulation of nonspecific binding in ultrafiltration protein binding studies. Pharm. Res. 20(7), 1015–1021 (2003).
  • Zhang F , XueJ, ShaoJet al. Compilation of 222 drugs’ plasma protein binding data and guidance for study designs. Drug Discov. Today17(9–10), 475–485 (2012).
  • Musteata FM . Monitoring free drug concentrations: challenges. Bioanalysis3(15), 1753–1768 (2011).
  • Timmerman P , KallMA, GordonBet al. Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum. Bioanalysis2(7), 1185–1194 (2010).
  • Rapid Equilibrium Dialysis (RED) Device. www.piercenet.com/product/rapid-equilibrium-dialysis-red
  • Mei H , HsiehY, NardoCet al. Investigation of matrix effects in bioanalytical high-performance liquid chromatography/tandem mass spectrometric assays: application to drug discovery. Rapid Commun. Mass Spectrom. 17(1), 97–103 (2003).
  • Matuszewski BK , ConstanzerML, Chavez-EngCM. Matrix effect in quantitative LC–MS/MS analyses of biological fluids: a method for determination of finasteride in human plasma at picogram per milliliter concentrations. Anal. Chem. 70(5), 882–889 (1998).
  • Matuszewski BK , ConstanzerML, Chavez-EngCM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC–MS/MS. Anal. Chem. 75(13), 3019–3030 (2003).
  • Müller C , SchäferP, StörtzelMet al. Ion suppression effects in liquid chromatography–electrospray-ionisation transport-region collision induced dissociation mass spectrometry with different serum extraction methods for systematic toxicological analysis with mass spectra libraries. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 773(1), 47–52 (2002).
  • Choi BK , HerculesDM, GusevAI. Effect of liquid chromatography separation of complex matrices on liquid chromatography–tandem mass spectrometry signal suppression. J. Chromatogr. A907(1–2), 337–342 (2001).
  • Bonfiglio R , KingRC, OlahTVet al. The effects of sample preparation methods on the variability of the electrospray ionization response for model drug compounds. Rapid Commun. Mass Spectrom. 13(12), 1175–1185 (1999).
  • Larger PJ , BredaM, FraierDet al. Ion-suppression effects in liquid chromatography–tandem mass spectrometry due to a formulation agent, a case study in drug discovery bioanalysis. J. Pharm. Biomed. Anal. 39(1–2), 206–216 (2005).
  • Xu X , MeiH, WangSet al. A study of common discovery dosing formulation components and their potential for causing time-dependent matrix effects in high-performance liquid chromatography tandem mass spectrometry assays. Rapid Commun. Mass Spectrom. 19(18), 2643–2650 (2005).
  • Schuhmacher J , ZimmerD, TescheFet al. Matrix effects during analysis of plasma samples by electrospray and atmospheric pressure chemical ionization mass spectrometry: practical approaches to their elimination. Rapid Commun. Mass Spectrom. 17(17), 1950–1957 (2003).
  • Tong XS , WangJ, ZhengSet al. Effect of signal interference from dosing excipients on pharmacokinetic screening of drug candidates by liquid chromatography–mass spectrometry. Anal. Chem. 74(24), 6305–6313 (2002).
  • Dell D . Labile metabolites. Chromatographia59(2 Suppl.), 139–148 (2004).
  • Regan SL , MaggsJL, HammondTGet al. Acyl glucuronides: the good, the bad and the ugly. Biopharm. Drug Dispos. 31(7), 367–395 (2010).

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:

Order Reprints Request Corporate Permissions

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:

Request Academic Permissions

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.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.