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Volumn 25, Issue 8, 2008, Pages 1956-1962

Bioavailability and bioequivalence: Focus on physiological factors and variability

Author keywords

Bioavailability and bioequivalence; Highly variable drugs; Impact of variability on BE studies; Physiological factors affecting drug absorption

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; DRUG METABOLITE; PARACETAMOL; RANITIDINE;

EID: 46749104406     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9645-9     Document Type: Conference Paper
Times cited : (49)

References (49)
  • 1
    • 1842295952 scopus 로고
    • Physiological availability of the vitamins. I. the human bioassasy technique
    • D. Melnick, M. Hochberg, and B. L. Oser. Physiological availability of the vitamins. I. The human bioassasy technique. J. Nutr. 30:67-79 (1945).
    • (1945) J. Nutr. , vol.30 , pp. 67-79
    • Melnick, D.1    Hochberg, M.2    Oser, B.L.3
  • 2
    • 46749104564 scopus 로고
    • Further studies on the relation between in vitro disintegration time of tablets and the urinary excretion rates of riboflavin
    • A. Morrison, D. Chapman, and J. Campbell. Further studies on the relation between in vitro disintegration time of tablets and the urinary excretion rates of riboflavin. J. Am. Pharm. Assoc. 48:634-637 (1959).
    • (1959) J. Am. Pharm. Assoc. , vol.48 , pp. 634-637
    • Morrison, A.1    Chapman, D.2    Campbell, J.3
  • 3
    • 46749130963 scopus 로고
    • The relationship between physiological availability of salicylates and riboflavin and in vitro disintegration time of enteric coated tablets
    • A. Morrison, and J. Campbell. The relationship between physiological availability of salicylates and riboflavin and in vitro disintegration time of enteric coated tablets. J. Am. Pharm. Assoc. 49:473-478 (1960).
    • (1960) J. Am. Pharm. Assoc. , vol.49 , pp. 473-478
    • Morrison, A.1    Campbell, J.2
  • 4
    • 2442556952 scopus 로고
    • Relationship between rate of dissolution, disintegration time, and physiological availability of riboflavin in sugar-coated tablets
    • E. Middleton, J. Davies, and A. Morrison. Relationship between rate of dissolution, disintegration time, and physiological availability of riboflavin in sugar-coated tablets. J. Pharm. Sci. 53:1378-1380 (1964).
    • (1964) J. Pharm. Sci. , vol.53 , pp. 1378-1380
    • Middleton, E.1    Davies, J.2    Morrison, A.3
  • 5
    • 0004691796 scopus 로고
    • Comparison of dissolution and absorption rates of different commercial aspirin tablets
    • G. Levy. Comparison of dissolution and absorption rates of different commercial aspirin tablets. J. Pharm. Sci. 50:388-392 (1961).
    • (1961) J. Pharm. Sci. , vol.50 , pp. 388-392
    • Levy, G.1
  • 6
    • 0002846475 scopus 로고
    • Effect of particle size on dissolution and gastrointestinal absorption rates of pharmaceuticals
    • G. Levy. Effect of particle size on dissolution and gastrointestinal absorption rates of pharmaceuticals. Am. J. Pharm. Sci. 135:78-92 (1963).
    • (1963) Am. J. Pharm. Sci. , vol.135 , pp. 78-92
    • Levy, G.1
  • 7
    • 0014309824 scopus 로고
    • An evaluation of the absorption characteristics of different chloramphenicol preparations in normal human subjects
    • 4
    • A. Glazko, A. Kinkel, W. Alegnani, and E. Holmes. An evaluation of the absorption characteristics of different chloramphenicol preparations in normal human subjects. Clin. Pharmacol. Ther. 9(4):472-483 (1968).
    • (1968) Clin. Pharmacol. Ther. , vol.9 , pp. 472-483
    • Glazko, A.1    Kinkel, A.2    Alegnani, W.3    Holmes, E.4
  • 8
    • 0032927254 scopus 로고    scopus 로고
    • Drug, meal and formulation interactions influencing drug absorption after oral administration clinical implications
    • 3
    • D. Fleisher, C. Li, Y. Zhou, L.H. Pao, and A. Karim. Drug, meal and formulation interactions influencing drug absorption after oral administration clinical implications. Clin. Pharmacokinet. 36(3):233-254 (1999).
    • (1999) Clin. Pharmacokinet. , vol.36 , pp. 233-254
    • Fleisher, D.1    Li, C.2    Zhou, Y.3    Pao, L.H.4    Karim, A.5
  • 10
    • 0022457224 scopus 로고
    • Food effects on propranolol systemic and oral clearance: Support for a blood flow hypothesis
    • L. Olanoff, T. Walle, T. Cowart, W. Walle, M. Oexmann, and E. Conradi. Food effects on propranolol systemic and oral clearance: support for a blood flow hypothesis. Clin. Pharmacol. Ther. 40:408-414 (1986).
    • (1986) Clin. Pharmacol. Ther , vol.40 , pp. 408-414
    • Olanoff, L.1    Walle, T.2    Cowart, T.3    Walle, W.4    Oexmann, M.5    Conradi, E.6
  • 11
    • 0025238674 scopus 로고
    • High-fat meals increase the clearance of cyclosporine
    • S. Gupta, and L. Benet. High-fat meals increase the clearance of cyclosporine. Pharm. Res. 7:46-48 (1990).
    • (1990) Pharm. Res. , vol.7 , pp. 46-48
    • Gupta, S.1    Benet, L.2
  • 12
    • 0019723260 scopus 로고
    • Drug interactions occurring during absorption from the gastrointestinal tract
    • J. Griffin. Drug interactions occurring during absorption from the gastrointestinal tract. Pharmacol. Ther. 15:79-88 (1981).
    • (1981) Pharmacol. Ther. , vol.15 , pp. 79-88
    • Griffin, J.1
  • 13
    • 0023551169 scopus 로고
    • The influence of nutrition on the systemic availability of drugs. Part I: Drug absorption
    • I. Walter-Sack. The influence of nutrition on the systemic availability of drugs. Part I: drug absorption. Klin. Wochenschr. 65:927-935 (1987).
    • (1987) Klin. Wochenschr. , vol.65 , pp. 927-935
    • Walter-Sack, I.1
  • 14
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • G. Amidon, H. Lennernas, V. Shah, and J. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12:413-420 (1995).
    • (1995) Pharm. Res , vol.12 , pp. 413-420
    • Amidon, G.1    Lennernas, H.2    Shah, V.3    Crison, J.4
  • 17
    • 0001152155 scopus 로고
    • The gastric secretion of drugs: A pH partition hypothesis
    • 3
    • P. Shore, B. Brodie, and C. Hogben. The gastric secretion of drugs: a pH partition hypothesis. J. Pharmacol. Exp. Ther. 119(3):361-369 (1957).
    • (1957) J. Pharmacol. Exp. Ther. , vol.119 , pp. 361-369
    • Shore, P.1    Brodie, B.2    Hogben, C.3
  • 18
    • 0002698633 scopus 로고
    • Advanced quantitative and mechanistic approaches in interfacing gastrointestinal drug absorption studies in animals and humans
    • American Pharmaceutical Association Washington, DC
    • N. Ho, J. Park, P. Ni, and W. Higuchi. Advanced quantitative and mechanistic approaches in interfacing gastrointestinal drug absorption studies in animals and humans. In W. Crouthanel, and A. C. Sarapu (eds.), Animal models for oral drug delivery in man: In situ and in vivo approaches, American Pharmaceutical Association, Washington, DC, 1983, pp. 27-106.
    • (1983) Animal Models for Oral Drug Delivery in Man: In Situ and in Vivo Approaches , pp. 27-106
    • Ho, N.1    Park, J.2    Ni, P.3    Higuchi, W.4    Crouthanel, W.5    Sarapu, A.C.6
  • 19
    • 0022070123 scopus 로고
    • Absorption potential: Estimating the fraction absorbed for orally administered compounds
    • 5
    • J. Dressman, G. Amidon, and D. Fleisher. Absorption potential: estimating the fraction absorbed for orally administered compounds. J. Pharm. Sci. 74(5):588-589 (1985).
    • (1985) J. Pharm. Sci. , vol.74 , pp. 588-589
    • Dressman, J.1    Amidon, G.2    Fleisher, D.3
  • 21
    • 0026017142 scopus 로고
    • The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect
    • 1
    • M. Chen, and A. Jackson. The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect. Pharm. Res. 8(1):25-32 (1991).
    • (1991) Pharm. Res. , vol.8 , pp. 25-32
    • Chen, M.1    Jackson, A.2
  • 22
    • 0029077354 scopus 로고
    • The role of metabolites in bioequivalency assessment. II. Drugs with linear pharmacokinetics and first-pass effect
    • 5
    • M. Chen, and A. Jackson. The role of metabolites in bioequivalency assessment. II. Drugs with linear pharmacokinetics and first-pass effect. Pharm. Res. 12(5):700-708 (1995).
    • (1995) Pharm. Res. , vol.12 , pp. 700-708
    • Chen, M.1    Jackson, A.2
  • 23
    • 0034495152 scopus 로고    scopus 로고
    • The role of metabolites in bioequivalency assessment. III. Highly variable drugs with linear kinetics and first-pass effect
    • 11
    • A. Jackson. The role of metabolites in bioequivalency assessment. III. Highly variable drugs with linear kinetics and first-pass effect. Pharm. Res. 17(11):1432-1436 (2000).
    • (2000) Pharm. Res. , vol.17 , pp. 1432-1436
    • Jackson, A.1
  • 24
    • 3242772217 scopus 로고    scopus 로고
    • Metabolites and bioequivalence: Past and present
    • 10
    • A. Jackson, G. Robbie, and P. Marroum. Metabolites and bioequivalence: past and present. Clin Pharmacokinet. 43(10):655-672 (2004).
    • (2004) Clin Pharmacokinet. , vol.43 , pp. 655-672
    • Jackson, A.1    Robbie, G.2    Marroum, P.3
  • 25
    • 4344678870 scopus 로고    scopus 로고
    • The role of metabolites in bioequivalence
    • 8
    • K. Midha, M. Rawson, and J. Hubbard. The role of metabolites in bioequivalence. Pharm. Res. 21(8):1331-1344 (2004).
    • (2004) Pharm. Res. , vol.21 , pp. 1331-1344
    • Midha, K.1    Rawson, M.2    Hubbard, J.3
  • 26
    • 0037378726 scopus 로고    scopus 로고
    • Segmental intestinal transporters and metabolic enzymes on intestinal drug absorption
    • 4
    • D. Tam, R. Tirona, and K. Pang. Segmental intestinal transporters and metabolic enzymes on intestinal drug absorption. Drug Metab. Dispos. 31(4):373-383 (2003).
    • (2003) Drug Metab. Dispos. , vol.31 , pp. 373-383
    • Tam, D.1    Tirona, R.2    Pang, K.3
  • 27
    • 0035478779 scopus 로고    scopus 로고
    • Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    • B. Agoram, W. Woltosz, and M. Bolger. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv. Drug Deliv. Rev. 50:S41-S67 (2001).
    • (2001) Adv. Drug Deliv. Rev. , vol.50
    • Agoram, B.1    Woltosz, W.2    Bolger, M.3
  • 28
    • 17644380257 scopus 로고    scopus 로고
    • Predicting drug disposition via application of BCS: Transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system
    • 1
    • C. Wu, and L. Benet. 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).
    • (2005) Pharm. Res. , vol.22 , pp. 11-23
    • Wu, C.1    Benet, L.2
  • 30
    • 0027141414 scopus 로고
    • Bio-International '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies
    • 11
    • H. Blume, and K. Midha. Bio-International '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. J. Pharm. Sci. 82(11):1186-1189 (1993).
    • (1993) J. Pharm. Sci. , vol.82 , pp. 1186-1189
    • Blume, H.1    Midha, K.2
  • 31
    • 0029940802 scopus 로고    scopus 로고
    • Absorption rate vs. exposure: Which is more useful for bioequivalence testing
    • 3
    • T. Tozer, F. Bois, W. Hauck, M. Chen, and R. Williams. Absorption rate vs. exposure: which is more useful for bioequivalence testing. Pharm. Res. 13(3):453-456 (1996).
    • (1996) Pharm. Res. , vol.13 , pp. 453-456
    • Tozer, T.1    Bois, F.2    Hauck, W.3    Chen, M.4    Williams, R.5
  • 32
    • 0003478656 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP). European Agency for the Evaluation of Medicinal Products London
    • Committee for Proprietary Medicinal Products (CPMP). European Agency for the Evaluation of Medicinal Products. Note for Guidance on the Investigation of Bioavailability and Bioequivalence, London, 2001.
    • (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence
  • 35
    • 0001135668 scopus 로고
    • Practical strategies and design advantages in highly variable drug studies: Multiple dose and replicate administration design
    • H. H. Blume and K. Midha (eds.) Medpharm, Stuttgart
    • H. Blume, M. Elze, H. Potthast, and B. Schug. Practical strategies and design advantages in highly variable drug studies: multiple dose and replicate administration design. In H. H. Blume and K. Midha (eds.), Bio-international '92: Bioavailability, Bioequivalence, and Pharmacokinetic Studies. Medpharm, Stuttgart, 1995, pp. 117-122.
    • (1995) Bio-international '92: Bioavailability, Bioequivalence, and Pharmacokinetic Studies , pp. 117-122
    • Blume, H.1    Elze, M.2    Potthast, H.3    Schug, B.4
  • 38
    • 0023248387 scopus 로고
    • Prediction of steady-state bioequivalence relationships using single dose data I-linear kinetics
    • 5
    • A. Jackson. Prediction of steady-state bioequivalence relationships using single dose data I-linear kinetics. Biopharm. Drug Dispos. 8(5):483-496 (1987).
    • (1987) Biopharm. Drug Dispos. , vol.8 , pp. 483-496
    • Jackson, A.1
  • 39
    • 0001668733 scopus 로고
    • Federal Register. 42:1621-1653 (1977).
    • (1977) Federal Register , vol.42 , pp. 1621-1653
  • 40
    • 84988173955 scopus 로고
    • Federal Register. 45:56832 (1980).
    • (1980) Federal Register , vol.45 , pp. 56832
  • 42
    • 0029567034 scopus 로고
    • An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs
    • A. Boddy, F. Snikeris, R. Kringle, G. Wei, J. Oppermann, and K. Midha. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharm. Res. 12:1865-1868 (1995).
    • (1995) Pharm. Res. , vol.12 , pp. 1865-1868
    • Boddy, A.1    Snikeris, F.2    Kringle, R.3    Wei, G.4    Oppermann, J.5    Midha, K.6
  • 43
    • 0032055171 scopus 로고    scopus 로고
    • Bioequivalence: Switchability and scaling
    • K. Midha, M. Rawson, and J. Hubbard. Bioequivalence: switchability and scaling. Eur. J. Pharm. Sci. 6:87-91 (1998).
    • (1998) Eur. J. Pharm. Sci , vol.6 , pp. 87-91
    • Midha, K.1    Rawson, M.2    Hubbard, J.3
  • 44
    • 0037337782 scopus 로고    scopus 로고
    • Limits for the scaled average bioequivalence of highly variable drugs and drug products
    • L. Tothfalusi, and L. Endrenyi. Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharm. Res. 20:382-389 (2003).
    • (2003) Pharm. Res. , vol.20 , pp. 382-389
    • Tothfalusi, L.1    Endrenyi, L.2
  • 46
    • 23244434225 scopus 로고    scopus 로고
    • Geometric mean ratio dependent scaled bioequivalence limits with levelling-off properties
    • V. Karalis, P. Macheras, and M. Symillides. Geometric mean ratio dependent scaled bioequivalence limits with levelling-off properties. Eur. J. Pharm. Sci. 26:54-61 (2005).
    • (2005) Eur. J. Pharm. Sci. , vol.26 , pp. 54-61
    • Karalis, V.1    MacHeras, P.2    Symillides, M.3
  • 47
    • 6344293527 scopus 로고    scopus 로고
    • Novel scaled average bioequivalence limits based on GMR and variability considerations
    • V. Karalis, M. Symillides, and P. Macheras. Novel scaled average bioequivalence limits based on GMR and variability considerations. Pharm. Res. 21:1933-1942 (2004).
    • (2004) Pharm. Res. , vol.21 , pp. 1933-1942
    • Karalis, V.1    Symillides, M.2    MacHeras, P.3
  • 48
    • 33750613025 scopus 로고    scopus 로고
    • Novel scaled bioequivalence limits with levelling-off properties
    • J. Kytariolos, V. Karalis, P. Macheras, and M. Symillides. Novel scaled bioequivalence limits with levelling-off properties. Pharm. Res. 23:2657-2664 (2006).
    • (2006) Pharm. Res. , vol.23 , pp. 2657-2664
    • Kytariolos, J.1    Karalis, V.2    MacHeras, P.3    Symillides, M.4


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