메뉴 건너뛰기




Volumn 104, Issue 9, 2015, Pages 3154-3161

An Assessment of the Oral Bioavailability of Three Ca-Channel Blockers Using a Cassette-Microdose Study: A New Strategy for Streamlining Oral Drug Development

Author keywords

bioavailability; cassette dose; clinical study; dose proportionality; first pass metabolism; microdose; Nonlinear pharmacokinetics; oral absorption

Indexed keywords

DILTIAZEM; NICARDIPINE; NIFEDIPINE; CALCIUM CHANNEL BLOCKING AGENT;

EID: 84939260630     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24499     Document Type: Article
Times cited : (10)

References (31)
  • 2
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J,. 2004. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3: 711-715.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 3
    • 77955473879 scopus 로고    scopus 로고
    • Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals Dated 11 June 2009, Accessed at
    • ICH Harmonised Tripartite Guideline. 2009. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Dated 11 June 2009, Accessed at: http://www.ich.org/.
    • (2009) ICH Harmonised Tripartite Guideline
  • 5
    • 58149188094 scopus 로고    scopus 로고
    • The utility of microdosing over the past 5 years. Expert Opin Drug Metab Toxicol
    • Lappin G, Garner R.C,. 2008. The utility of microdosing over the past 5 years. Expert Opin Drug Metab Toxicol. 4: 1499-1506.
    • (2008) , vol.4 , pp. 1499-1506
    • Lappin, G.1    Garner, R.C.2
  • 6
    • 79957782000 scopus 로고    scopus 로고
    • Impact of microdosing clinical study - Why necessary and how useful?
    • Sugiyama Y, Yamashita S,. 2011. Impact of microdosing clinical study-Why necessary and how useful? Adv Drug Deliv Rev 63: 494-502.
    • (2011) Adv Drug Deliv Rev , vol.63 , pp. 494-502
    • Sugiyama, Y.1    Yamashita, S.2
  • 7
    • 0037277752 scopus 로고    scopus 로고
    • Drug metabolism and pharmacokinetics in drug discovery
    • Roberts SA., 2003. Drug metabolism and pharmacokinetics in drug discovery. Curr Opin Drug Discov Dev 6: 66-80.
    • (2003) Curr Opin Drug Discov Dev , vol.6 , pp. 66-80
    • Roberts, S.A.1
  • 8
    • 23944515735 scopus 로고    scopus 로고
    • A novel model for prediction of human drug clearance by allometric scaling
    • Tang H, Mayersohn M,. 2005. A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 33: 1297-1303.
    • (2005) Drug Metab Dispos , vol.33 , pp. 1297-1303
    • Tang, H.1    Mayersohn, M.2
  • 9
    • 33748363499 scopus 로고    scopus 로고
    • Interspecies allometric scaling. Part I: Prediction of clearance in large animals
    • Mahmood I, Martinez M, Hunter RP,. 2006. Interspecies allometric scaling. Part I: Prediction of clearance in large animals. J Vet Pharmacol Ther 29: 415-423.
    • (2006) J Vet Pharmacol Ther , vol.29 , pp. 415-423
    • Mahmood, I.1    Martinez, M.2    Hunter, R.P.3
  • 10
    • 70349645316 scopus 로고    scopus 로고
    • The species differences of intestinal drug absorption and first-pass metabolism between cynomolgus monkeys and humans
    • Takahashi M, Washio T, Suzuki N, Igeta K, Yamashita S,. 2009. The species differences of intestinal drug absorption and first-pass metabolism between cynomolgus monkeys and humans. J Pharm Sci 98: 4343-4353.
    • (2009) J Pharm Sci , vol.98 , pp. 4343-4353
    • Takahashi, M.1    Washio, T.2    Suzuki, N.3    Igeta, K.4    Yamashita, S.5
  • 11
  • 12
    • 0024571757 scopus 로고
    • The absolute oral bioavailability of selected drugs
    • Sietsema WK., 1989. The absolute oral bioavailability of selected drugs. Int J Clin Pharmacol Ther Toxicol 27: 179-211.
    • (1989) Int J Clin Pharmacol Ther Toxicol , vol.27 , pp. 179-211
    • Sietsema, W.K.1
  • 14
    • 79961169355 scopus 로고    scopus 로고
    • Clinical relevance of liquid chromatography tandem mass spectrometry as an analytical method in microdose clinical studies
    • Yamane N, Tozuka Z, Kusama M, Maeda K, Ikeda T, Sugiyama Y,. 2011. Clinical relevance of liquid chromatography tandem mass spectrometry as an analytical method in microdose clinical studies. Pharm Res 28: 1963-1972.
    • (2011) Pharm Res , vol.28 , pp. 1963-1972
    • Yamane, N.1    Tozuka, Z.2    Kusama, M.3    Maeda, K.4    Ikeda, T.5    Sugiyama, Y.6
  • 15
  • 16
    • 0022981349 scopus 로고
    • Clinical pharmacokinetics of verapamil, nifedipine and diltiazem
    • Echizen H, Eichelbaum M,. 1986. Clinical pharmacokinetics of verapamil, nifedipine and diltiazem. Clin Pharmacokinet 11: 425-449.
    • (1986) Clin Pharmacokinet , vol.11 , pp. 425-449
    • Echizen, H.1    Eichelbaum, M.2
  • 18
    • 84939293580 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM) Guidance for industry. Bioanalytical method validation. Dated May 2001. Accessed at: at
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). 2001. Guidance for industry. Bioanalytical method validation. Dated May 2001. Accessed at: at http://www.fda.gov/.
    • (2001)
  • 20
    • 84879249429 scopus 로고    scopus 로고
    • Microdosing and drug development: Past, present and future
    • Lappin G, Noveck R, Burt T,. 2013. Microdosing and drug development: Past, present and future. Expert Opin Drug Metab Toxicol 9: 817-834.
    • (2013) Expert Opin Drug Metab Toxicol , vol.9 , pp. 817-834
    • Lappin, G.1    Noveck, R.2    Burt, T.3
  • 22
    • 0034468612 scopus 로고    scopus 로고
    • Effects of grapefruit juice on the stereoselective disposition of nicardipine in humans: Evidence for dominant presystemic elimination at the gut site
    • Uno T, Ohkubo T, Sugawara K, Higashiyama A, Motomura S, Ishizaki T,. 2000. Effects of grapefruit juice on the stereoselective disposition of nicardipine in humans: Evidence for dominant presystemic elimination at the gut site. Eur J Clin Pharmacol 56: 643-649.
    • (2000) Eur J Clin Pharmacol , vol.56 , pp. 643-649
    • Uno, T.1    Ohkubo, T.2    Sugawara, K.3    Higashiyama, A.4    Motomura, S.5    Ishizaki, T.6
  • 23
    • 0036449361 scopus 로고    scopus 로고
    • Coadministration of grapefruit juice increases systemic exposure of diltiazem in healthy volunteers
    • Christensen H, Asberg A, Holmboe AB, Berg KJ,. 2002. Coadministration of grapefruit juice increases systemic exposure of diltiazem in healthy volunteers. Eur J Clin Pharmacol 58: 515-520.
    • (2002) Eur J Clin Pharmacol , vol.58 , pp. 515-520
    • Christensen, H.1    Asberg, A.2    Holmboe, A.B.3    Berg, K.J.4
  • 24
    • 0020511478 scopus 로고
    • Pharmacokinetics and metabolism of nifedipine
    • I
    • Raemsch KD, Sommer J,. 1983. Pharmacokinetics and metabolism of nifedipine. Hypertension 5 (4 Pt 2):I I18-24.
    • (1983) Hypertension , vol.5 , Issue.4 , pp. I18-I24
    • Raemsch, K.D.1    Sommer, J.2
  • 26
    • 0018897010 scopus 로고
    • Comparative pharmacokinetics of nicardipine hydrochloride, a new vasodilator, in various species
    • Higuchi S, Shiobara Y,. 1980. Comparative pharmacokinetics of nicardipine hydrochloride, a new vasodilator, in various species. Xenobiotic 10: 447-454.
    • (1980) Xenobiotic , vol.10 , pp. 447-454
    • Higuchi, S.1    Shiobara, Y.2
  • 29
    • 0021336416 scopus 로고
    • Pharmacokinetics and absolute bioavailability of diltiazem in humans
    • Ochs HR, Knüchel M,. 1984. Pharmacokinetics and absolute bioavailability of diltiazem in humans. Klin Wochenschr 62: 303-306.
    • (1984) Klin Wochenschr , vol.62 , pp. 303-306
    • Ochs, H.R.1    Knüchel, M.2
  • 30
    • 21744436852 scopus 로고    scopus 로고
    • Cytochromes P450 and MDR1 mRNA expression along the human gastrointestinal tract
    • Thorn M, Finnstrom N, Lundgren S, Rane A, Loof L,. 2005. Cytochromes P450 and MDR1 mRNA expression along the human gastrointestinal tract. Br J Clin Pharmacol 60: 54-60.
    • (2005) Br J Clin Pharmacol , vol.60 , pp. 54-60
    • Thorn, M.1    Finnstrom, N.2    Lundgren, S.3    Rane, A.4    Loof, L.5
  • 31
    • 1542376174 scopus 로고    scopus 로고
    • Cytochrome P450 3A4 and P-glycoprotein expression in human small intestinal enterocytes and hepatocytes: A comparative analysis in paired tissue specimens
    • Richter O, Burk O, Fromm M, Thon K, Eichelbaum M, Kivistö K,. 2004. Cytochrome P450 3A4 and P-glycoprotein expression in human small intestinal enterocytes and hepatocytes: A comparative analysis in paired tissue specimens. Clin Pharmacol Ther 75: 172-183.
    • (2004) Clin Pharmacol Ther , vol.75 , pp. 172-183
    • Richter, O.1    Burk, O.2    Fromm, M.3    Thon, K.4    Eichelbaum, M.5    Kivistö, K.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.