AAPS-FDA workshop white paper: Microdialysis principles, application, and regulatory perspectives report from the joint AAPS-FDA workshop, November 4-5, 2005, Nashville, TN

AAPS Journal

Volumn 9, Issue 1, 2007, Pages

  Chaurasia, Chandra S ^a   Müller, Markus ^b   Bashaw, Edward D ^a   Benfeldt, Eva ^c   Bolinder, Jan ^d   Bullock, Ross ^e   Bungay, Peter M ^f   DeLange, Elizabeth C M ^g   Derendorf, Hartmut ^h   Elmquist, William F ⁱ   Hammarlund Udenaes, Margareta ^j   Joukhadar, Christian ^b   Kellogg Jr , Dean L ^k   Lunte, Craig E ^l   Nordstrom, Carl Henrik ^m   Rollema, Hans ⁿ   Sawchuk, Ronald J ⁱ   Cheung, Belinda W Y ⁱ   Shah, Vinod P ^o   Stahle, Lars ^p   Ungerstedt, Urban ^q   Welty, Devin F ^o   Yeo, Helen ^a   more..

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f NATIONAL INSTITUTES OF HEALTH   (United States)

^g LEIDEN UNIVERSITY   (Netherlands)

^h UNIVERSITY OF FLORIDA   (United States)

ⁱ UNIVERSITY OF MINNESOTA   (United States)

^j UPPSALA UNIVERSITY   (Sweden)

^k UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^l UNIVERSITY OF KANSAS   (United States)

^m LUND UNIVERSITY HOSPITAL   (Sweden)

ⁿ PFIZER INC   (United States)

^o Pfizer Global Research ^*  (United States)

^p KAROLINSKA INSTITUTE   (Sweden)

^q ALLERGAN INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADENOSINE; ADENOSINE TRIPHOSPHATE; ANESTHETIC AGENT; ANTINEOPLASTIC AGENT; BETA LACTAM ANTIBIOTIC; CENTRAL NERVOUS SYSTEM AGENTS; CPP 109; DRUGS USED IN THE TREATMENT OF ADDICTION; GLUCOSE; LACTIC ACID; LIDOCAINE; MACROLIDE; NEUROTRANSMITTER; NONSTEROID ANTIINFLAMMATORY AGENT; PIPERACILLIN; POTASSIUM ION; PYRUVIC ACID; QUINOLINE DERIVED ANTIINFECTIVE AGENT; THROMBOXANE B2; UNCLASSIFIED DRUG; ZONISAMIDE;

ANALGESIC ACTIVITY; BREAST CANCER; CALIBRATION; CAPILLARY ELECTROPHORESIS; COCAINE DEPENDENCE; CONFERENCE PAPER; DIALYSATE; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG EXPOSURE; DRUG MEGADOSE; DRUG PENETRATION; DRUG POTENCY; DRUG RESEARCH; DRUG SAFETY; DRUG SELECTIVITY; DRUG TARGETING; EQUIPMENT DESIGN; EXTRACELLULAR FLUID; FOOD AND DRUG ADMINISTRATION; FOREIGN BODY REACTION; GRAFT OCCLUSION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMPLANTATION; INTENSIVE CARE; LIVER TRANSPLANTATION; MASS SPECTROMETRY; MATHEMATICAL MODEL; MELANOMA; MICRODIALYSIS; NEUROTRANSMITTER RELEASE; NONHUMAN; OXIDATION REDUCTION STATE; PAIN; PHARMACODYNAMICS; SEPTIC SHOCK; SEPTICEMIA; TRAUMATIC BRAIN INJURY; UNSPECIFIED SIDE EFFECT;

EID: 33847378085     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0901006     Document Type: Conference Paper

References (65)

1. Ungerstedt U, Pycock C. Functional correlates of dopamine neurotransmission. Bull Schweiz Akad Med Wiss. 1974;30:44-55.
2. FDA. 2004; Available at: http://www.fda.gov/oc/initiatives/criticalpath/ whitepaper.pdf.
3. De Lange ECM, De Boer AG, Breimer DD, eds. Methodological issues in microdialysis sampling for pharmacokinetic studies. In: Sawchuck R, Elmquist WT, eds. Adv Drug Deliv Rev. vol. 45. 2000:125-148.
4. Elmquist WF, Sawchuk RJ. Application of microdialysis in pharmacokinetic studies. Pharm Res. 1997;14:267-288.
5. Chaurasia CS. In vivo microdialysis sampling: theory and applications. Biomed Chromatogr. 1999;13:317-332.
6. De Lange ECM, Danhof M. Considerations in the use of cerebrospinal fluid pharmacokinetics to predict brain target concentrations in the clinical setting: implications of the barriers between blood and brain. Clin Pharmacokinet. 2002;41:691-703.
7. Davies MI, Cooper JD, Desmond SS, Lunte CE, Lunte SM. Analytical considerations for microdialysis sampling. Adv Drug Deliv Rev. 2000; 45: 169-188.
8. De Lange ECM, Danhof M, De Boer AG, Breimer DD. Methodological considerations of intracerebral microdialysis in pharmacokinetic studies on blood-brain barrier transport of drugs. Brain Res Rev. 1997;25:27-49.
9. Ungerstedt U. Microdialysis - principles and applications for studies in animals and man. J Intern Med. 1991;230:365-373.
10. De Lange ECM, De Bock AH, De Boer AG, Breimer DD. BBB transport and P-glycoprotein functionality using MDR1A (-/-) and wild-type mice: total brain versus microdialysis concentration profiles of rhodamine-123. Pharm Res. 1998;15:1657-1665.
11. Bungay PM, Dedrick RL, Fox E, Balis FM. Probe calibration in transient microdialysis in vivo. Pharm Res. 2001;18:361-366.
12. Smith AD, Jr, Justice JB, Jr. The effect of inhibition of synthesis, release, metabolism and uptake on the microdialysis extraction fraction of dopamine. J Neuorsci Meth. 1994;54:75-82.
13. De Lange ECM, Ravenstijn PGM, Groenendaal D, van Steeg TS. Towards the prediction of CNS drug effect profiles in physiological and pathological conditions using microdialysis and mechanism-based pharmacokinetic-pharmacodynamic modeling. AAPS J. 2005;7:E532-E543.
14. Ederoth P, Tunblad K, Bouw R, et al. Blood-brain barrier transport of morphine in patients with severe brain trauma. Br J Clin Pharmacol. 2004;57:427-435.
15. Stolle LB, Arpi M, Holmberg-Jorgensen P, Riegels-Nielsen P, Keller J. Application of microdialysis to cancellous bone tissue for measurement of gentamicin levels. J Antimicrob Chemother. 2004;54:263-265.
16. Cheung BW, Cartier LL, Giebink GS, Sawchuk RJ. Simultaneous intravenous and intramiddle-ear dosing to determine cefditoren influx and efflux clearances in middle ear fluid in freely moving chinchillas. J Pharm Sci. 2003;92:1947-1956.
17. Skilling SR, Smullin DH, Beitz AJ, Larson AA. Extracellular amino acid concentrations in the dorsal spinal cord of freely moving rats following veratridine and nociceptive stimulation. J Neurochem. 1988;51:127-132.
18. Anand BS, Atluri H, Mitra AK. Validation of an ocular microdialysis technique in rabbits with permanently implanted vitreous probes: systemic and intravitreal pharmacokinetics of fluorescein. Int J Pharmaceutics. 2004;281:79-88.
19. Qian M, West W, Wu JT, Lu B, Christ DD. Development of a dog microdialysis model for determining synovial fluid pharmacokinetics of anti-arthritis compounds exemplifi ed by methotrexate. Pharm Res. 2003;20:605-610.
20. Solligård E, Juel IS, Bakkelund K, et al. Gut luminal microdialysis of glycerol as a marker of intestinal ischemic injury and recovery. Crit Care Med. 2005;33:2278-2285.
21. Krupp JL, Bernards CM. Pharmacokinetics of intrathecal oligodeoxynucleotides. Anesthesiology. 2004;100:315-322.
22. Wang Y, Sawchuk RJ. Zidovudine transport in the rabbit brain during intravenous and intracerebroventricular infusion. J Pharm Sci. 1995;84:871-876.
23. Riese J, Boecker S, Hohenberger W, Klein P, Haupt W. Microdialysis: a new technique to monitor preoperative human peritoneal mediator production. Surg Infect (Larchmt). 2003;4:11-15.
24. Brunner M, Muller M. Microdialysis: an in vivo approach for measuring drug delivery in oncology. Eur J Clin Pharmacol. 2002;58:227-234.
25. Galvan A, Smith Y, Wichmann T. Continuous monitoring of intracerebral glutamate levels in awake monkeys using microdialysis and enzyme fluorometric detection. J Neurosci Methods. 2003;126:175-185.
26. Morrison PF, Bungay PM, Hsiao JK, Mefford IN, Dykstra KH, Dedrick RL, eds. Quantitative microdialysis. In: Robinson TE, Justice JB Jr., eds. Microdialysis in the Neurosciences. New York, NY: Elsevier; 1996:47-80.
27. Chen KC, Höistad M, Kehr J, Fuxe JK, Nicholson C. Theory relating in vitro and in vivo microdialysis of one or two probes. J Neurochem. 2002;81:108-121.
28. Bungay PM, Morrison PF, Dedrick RL, Chefer VI, Zapata A, eds. Principles of quantitative microdialysis. In: Westerink BHC, Cremers TIFH, eds. Handbook of Microdialysis Vol. 16: Methods, Applications and Perspectives. New York, NY: Elsevier; in press;.
29. Lönnroth P, Jansson PA, Smith U. A microdialysis method allowing characterization of intercellular water space in humans. Am J Physiol. 1987;253:E228-E231.
30. Olson RJ, Jr, Justice JB, Jr. Quantitative microdialysis under transient conditions. Anal Chem. 1993;65:1017-1022.
31. Wang Y, Wong SL, Sawchuk RJ. Microdialysis calibration using retrodialysis and zero-net flux: application to a study of the distribution of zidovudine to rabbit cerebrospinal fluid and thalamus. Pharm Res. 1993;10:1411-1419.
32. Bouw MR, Hammarlund-Udenaes M. Methodological aspects of the use of a calibrator in in vivo microdialysis - further development of the retrodialysis method. Pharm Res. 1998;15:1673-1679.
33. Strindberg L, Lönnroth P. Validation of an endogenous reference technique for the calibration of microdialysis catheters. Scand J Clin Lab Invest. 2000;60:205-211.
34. Yang H, Peters JL, Michael AC. Coupled effects of mass transfer and uptake kinetics on in vivo microdialysis of dopamine. J Neurochem. 1998;71:684-692.
35. Bungay PM, Jr, Newton-Vinson P, Jr, Isele W, Jr, Garris PA, Jr, Justice JB, Jr. Microdialysis of dopamine interpreted with quantitative model incorporating probe implantation trauma. J Neurochem. 2003;86:932-946.
36. Chen KC. Effects of tissue trauma on the characteristics of microdialysis zero-net-flux method sampling neurotransmitters. J Theor Biol. 2006;238:863-881.
37. Dykstra KH, Hsiao JK, Morrison PF, et al. Quantitative examination of tissue concentration profiles associated with microdialysis. J Neurochem. 1992;58:931-940.
38. 3H]mannitol diffusion in agar and rat striatum. J Neurochem. 2002;81:80-93.
39. Lönnroth P, Strindberg L. Validation of the 'internal reference technique' for calibrating microdialysis catheters in situ. Acta Physiol Scand. 1995;153:375-380.
40. Müller M. Science, medicine and the future: microdialysis. BMJ. 2002;324:588-591.
41. Müller M. Microdialysis in clinical drug delivery studies. Adv Drug Deliv Rev. 2000;45:255-269.
42. Kennergren C, Mantovani V, Strindberg L, Berglin E, Hamberger A, Lönnroth P. Myocardial interstitial glucose and lactate before, during, and after cardioplegic heart arrest. Am J Physiol Endocrinol Metab. 2003;284:E788-E794.
43. Bellander BM, Cantais E, Enblad P, et al. Consensus meeting on microdialysis in neurointensive care. Intensive Care Med. 2004;30:2166-2169.
44. Tolias CM, Bullock MR. Critical appraisal of neuroprotection T1 injury: what have we learned? NeuroRx. 2004;1:71-79.
45. Müller M, dela Pena A, Derendorf H. Issues in pharmacokinetics and pharmacodynamics of anti-infective agents: distribution in tissue. Antimicrob Agents Chemother. 2004;48:1441-1453.
46. Brunner M, Derendorf H, Müller M. Microdialysis for in vivo pharmacokinetic/pharmacodynamic characterization of anti-infective drugs. Curr Opin Pharmacol. 2005;5:495-499.
47. Brunner M, Müller M. Microdialysis: an in vivo approach for measuring drug delivery in oncology. Eur J Clin Pharmacol. 2002; 58:227-234.
48. Shah VP, Flynn GL, Yacobi A, et al. Bioequivalence of topical dermatological dosage forms - methods of evaluation of bioequivalence. Pharm Res. 1998;15:167-171.
49. Kreilgaard M, Kemme MJ, Burggraff J, Schoemaker RC, Cohen AF. Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics. Pharm Res. 2001;18:593-599.
50. Groth L, García O, Benfeldt E, eds. Microdialysis Methodology for Sampling in the Skin. In: Serup J, Jemec JBE, Grove G, eds. Handbook of Non-Invasive Methods and the Skin. Boca Raton, FL: CRC Press; 2006:443-454.
51. Benfeldt E, Serup J, Menne T. Effect of barrier perturbation on cutaneous salicylic acid penetration in human skin: in vivo pharmacokinetics using microdialysis and non-invasive quantification of barrier function. Br J Dermatol. 1999;140:739-748.
52. McDonald S, Lunte C. Determination of the dermal penetration of esterom components using microdialysis sampling. Pharm Res. 2003;20:1827-1834.
53. Benfeldt E, Hansen SH, Vølund A, Menné T, Shah VP. Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermato-pharmacokinetic method. J Invest Dermatol. 2007;127:170-178.
54. Lönnroth P. Microdialysis in adipose tissue and skeletal muscle. Horm Metab Res. 1997;29:344-346.
55. Magkos F, Sidossis LS. Methodological approaches to the study of metabolism across individual tissues in man. Curr Opin Clin Nutr Metab Care. 2005;8:501-510.
56. Qvisth V, Hagström-Toft E, Enoksson S, Sherwin RS, Sjöberg S, Bolinder J. Combined hyperinsulinemia, but not hyperinsulinemia alone, suppress human skeletal muscle lipolytic activity in vivo. J Clin Endocrinol Metab. 2004;89:4693-4700.
57. Bolinder J, Ungerstedt U, Arner P. Long-term continuous glucose monitoring with microdialysis in ambulatory insulin-dependent diabetic patients. Lancet. 1993;342:1080-1085.
58. Maran A, Crepaldi C, Tiengo A, et al. Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis. Diabetes Care. 2002;25:347-352.
59. Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005;28:1231-1239.
60. Kellogg DL Jr, Liu Y, Pergola PE, Roman LJ. In vivo measurement of nitric oxide concentrations in humans. FASEB J. 1999;13:.
61. CMA Cerebral Tissue Monitoring System. Available at: http://www.microdialysis.se/USA/PDF/510(k)%20Summary.pdf. Accessed October 23, 2006.
62. Physicians' Desk Reference. 2006; Available at: http://www.thomsonhc.com/ pdrel/librarian/PFDefaultActionId/pdrcommon.IndexSearchTranslator. Accessed October 23, 2006.
63. Catalyst Pharmaceuticals Partners Files Investigational New Drug Application for CPP-109 to Treat Cocaine Addiction. 2005; Available at: http://www.bnl.gov/CTN/GVG/CPP.asp. Accessed October 23, 2006.
64. Anti-Infective Drug Advisory Committee Meeting. 1998; Available at: http://0-www.fda.gov.lilac.une.edu/ohrms/dockets/ac/ cder98t.htm#Anti-InfectiveDrugs. Accessed October 23, 2006.
65. EMEA. 2006; Available at: http://www.emea.eu.int/pdfs/human/swp/ 9422704en.pdf. Accessed October 23, 2006.