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Volumn , Issue , 2000, Pages 229-254

Analysis of drug dissolution data

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EID: 85056934683     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (38)

References (68)
  • 2
    • 0030867432 scopus 로고    scopus 로고
    • Joint report of the section for official laboratories and medicines control services and the section of industrial pharmacists of the F.I.P
    • FIP guidelines for dissolution testing of solid oral products. Joint report of the section for official laboratories and medicines control services and the section of industrial pharmacists of the F.I.P. Pharm Ind 1997; 59: 760-766.
    • (1997) Pharm Ind , vol.59 , pp. 760-766
  • 3
    • 0030926727 scopus 로고    scopus 로고
    • Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets
    • Polli JE, Rekhi GS, Augsburger LL, Shah VP. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J Pharm Sci 1997; 86: 690-700.
    • (1997) J Pharm Sci , vol.86 , pp. 690-700
    • Polli, J.E.1    Rekhi, G.S.2    Augsburger, L.L.3    Shah, V.P.4
  • 4
    • 0029836972 scopus 로고    scopus 로고
    • Concept of mapping
    • Shah VP. Concept of mapping. Drug Inf J 1996; 30: 1085-1089.
    • (1996) Drug Inf J , vol.30 , pp. 1085-1089
    • Shah, V.P.1
  • 9
    • 0031913402 scopus 로고    scopus 로고
    • Dissolution testing as a prognostic tool for oral drug absorption: Immediate release forms
    • Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution testing as a prognostic tool for oral drug absorption: immediate release forms. Pharm Res 1998; 15: 11-22.
    • (1998) Pharm Res , vol.15 , pp. 11-22
    • Dressman, J.B.1    Amidon, G.L.2    Reppas, C.3    Shah, V.P.4
  • 10
    • 0000074294 scopus 로고
    • Parametric representation of dissolution-rate curves by the RRSBW distribution
    • Langenbucher F. Parametric representation of dissolution-rate curves by the RRSBW distribution. Pharm Ind 1976; 38: 472-477.
    • (1976) Pharm Ind , vol.38 , pp. 472-477
    • Langenbucher, F.1
  • 11
    • 0000463679 scopus 로고
    • Correlation of in vitro drug release with in vivo response kinetics. Part II: Use of function parameters
    • Langenbucher F, Moeller H. Correlation of in vitro drug release with in vivo response kinetics. Part II: Use of function parameters. Pharm Ind 1983; 45: 629-633.
    • (1983) Pharm Ind , vol.45 , pp. 629-633
    • Langenbucher, F.1    Moeller, H.2
  • 12
    • 0016422844 scopus 로고
    • The concept of dissolution efficiency
    • Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol 1975; 27: 28-49.
    • (1975) J Pharm Pharmacol , vol.27 , pp. 28-49
    • Khan, K.A.1
  • 13
    • 0030738943 scopus 로고    scopus 로고
    • Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis
    • Tsong Y, Hammerstrom T, Chen JJ. Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis. J Biopharm Stat 1997; 7: 423-439.
    • (1997) J Biopharm Stat , vol.7 , pp. 423-439
    • Tsong, Y.1    Hammerstrom, T.2    Chen, J.J.3
  • 14
    • 33947487639 scopus 로고
    • The rate of solution of solid substances in their own solutions
    • Noyes AA, Whitney WR. The rate of solution of solid substances in their own solutions. J Am Chem Soc 1897; 19: 756-761.
    • (1897) J Am Chem Soc , vol.19 , pp. 756-761
    • Noyes, A.A.1    Whitney, W.R.2
  • 15
    • 0000409522 scopus 로고
    • Ueber die Auflösungsgeschwindigkeit von festen Stoffen in ihren eigenen Lösungen
    • Noyes AA, Whitney WR. Ueber die Auflösungsgeschwindigkeit von festen Stoffen in ihren eigenen Lösungen. Z Phys Chem 1897; 23: 689-692.
    • (1897) Z Phys Chem , vol.23 , pp. 689-692
    • Noyes, A.A.1    Whitney, W.R.2
  • 16
    • 0002642747 scopus 로고
    • Theorie der Reaktionsgeschwindigkeit in heterogenen Systemen
    • Nernst W, Brunner E. Theorie der Reaktionsgeschwindigkeit in heterogenen Systemen. Z Phys Chem 1904; 47: 52-110.
    • (1904) Z Phys Chem , vol.47 , pp. 52-110
    • Nernst, W.1    Brunner, E.2
  • 18
    • 0001732841 scopus 로고
    • Studien über die Bildung und Umwandlung fester Körper
    • Ostwald W. Studien über die Bildung und Umwandlung fester Körper. Z Phys Chem 1897; 22: 289-330.
    • (1897) Z Phys Chem , vol.22 , pp. 289-330
    • Ostwald, W.1
  • 19
    • 0001854652 scopus 로고
    • Dissolution rates of finely divided powders II: Micronized methylprednisolone
    • Higuchi WI, Rowe EL, Hiestand EN. Dissolution rates of finely divided powders II: Micronized methylprednisolone. J Pharm Sci 1963; 52: 162-164.
    • (1963) J Pharm Sci , vol.52 , pp. 162-164
    • Higuchi, W.I.1    Rowe, E.L.2    Hiestand, E.N.3
  • 20
    • 84980206571 scopus 로고
    • Mass transfer to particles I. Suspended in agitated tanks
    • Harriott P. Mass transfer to particles I. Suspended in agitated tanks. Am Inst Chem Eng J 1962; 8: 93-101.
    • (1962) Am Inst Chem Eng J , vol.8 , pp. 93-101
    • Harriott, P.1
  • 21
    • 0001854651 scopus 로고
    • Dissolution rates of finely divided drug powders I. Effect of distribution of particle sizes in a diffusion-controlled process
    • Higuchi WI, Hiestand EN. Dissolution rates of finely divided drug powders I. Effect of distribution of particle sizes in a diffusion-controlled process. J Pharm Sci 1963; 52: 67-71.
    • (1963) J Pharm Sci , vol.52 , pp. 67-71
    • Higuchi, W.I.1    Hiestand, E.N.2
  • 23
    • 9144260123 scopus 로고
    • Dissolution rate studies I. Continuous recording technique for following rapid reaction in solution
    • Niebergall PJ, Goyan JE. Dissolution rate studies I. Continuous recording technique for following rapid reaction in solution. J Pharm Sci 1963; 52: 29-33.
    • (1963) J Pharm Sci , vol.52 , pp. 29-33
    • Niebergall, P.J.1    Goyan, J.E.2
  • 25
    • 0015296670 scopus 로고
    • Dissolution rate patterns of log-normally distributed powders
    • Carstensen JT, Musa MN. Dissolution rate patterns of log-normally distributed powders. J Pharm Sci 1972; 61: 223-227.
    • (1972) J Pharm Sci , vol.61 , pp. 223-227
    • Carstensen, J.T.1    Musa, M.N.2
  • 26
    • 0015661712 scopus 로고
    • Nonsink dissolution rate equation
    • Pothisiri P, Carstensen JT. Nonsink dissolution rate equation. J Pharm Sci 1973; 62: 1468-1470.
    • (1973) J Pharm Sci , vol.62 , pp. 1468-1470
    • Pothisiri, P.1    Carstensen, J.T.2
  • 27
    • 0016709318 scopus 로고
    • Dissolution patterns of polydisperse powders: Oxalic acid dihydrate
    • Carstensen JT, Patel M. Dissolution patterns of polydisperse powders: oxalic acid dihydrate. J Pharm Sci 1975; 64: 1770-1776.
    • (1975) J Pharm Sci , vol.64 , pp. 1770-1776
    • Carstensen, J.T.1    Patel, M.2
  • 28
    • 0017186983 scopus 로고
    • Theoretical isotropic dissolution of nonspherical particles
    • Pedersen PV, Brown KF. Theoretical isotropic dissolution of nonspherical particles. J Pharm Sci 1976; 65: 1437-1442.
    • (1976) J Pharm Sci , vol.65 , pp. 1437-1442
    • Pedersen, P.V.1    Brown, K.F.2
  • 29
    • 0027275798 scopus 로고
    • Dissolution modelling: Factors affecting the dissolution rate of polydisperse powders
    • Lu ATK, Frisella ME, Johnson KC. Dissolution modelling: factors affecting the dissolution rate of polydisperse powders. Pharm Res 1993; 10: 1308-1314.
    • (1993) Pharm Res , vol.10 , pp. 1308-1314
    • Lu, A.T.K.1    Frisella, M.E.2    Johnson, K.C.3
  • 30
    • 84887725686 scopus 로고
    • Dependence of reaction velocity upon surface and agitation. I. Theoretical considerations
    • Hixcon AW, Crowell JH. Dependence of reaction velocity upon surface and agitation. I. Theoretical considerations. Ind Eng Chem 1931; 23: 923-931.
    • (1931) Ind Eng Chem , vol.23 , pp. 923-931
    • Hixcon, A.W.1    Crowell, J.H.2
  • 31
    • 0030008217 scopus 로고    scopus 로고
    • Effect of change in shape factor of a single crystal on its dissolution behavior
    • Dali MV, Carstensen JT. Effect of change in shape factor of a single crystal on its dissolution behavior. Pharm Res 1996; 13: 155-162.
    • (1996) Pharm Res , vol.13 , pp. 155-162
    • Dali, M.V.1    Carstensen, J.T.2
  • 32
    • 0018159341 scopus 로고
    • Effect of shape factor on cube root dissolution behavior
    • Lai TY, Carstensen JT. Effect of shape factor on cube root dissolution behavior. Int J Pharm 1978; 1: 33-40.
    • (1978) Int J Pharm , vol.1 , pp. 33-40
    • Lai, T.Y.1    Carstensen, J.T.2
  • 33
    • 0024596954 scopus 로고
    • The effect of particle size distribution on dissolution rate and oral absorption
    • Hintz RJ, Johnson KC. The effect of particle size distribution on dissolution rate and oral absorption. Int J Pharm 1989; 51: 9-17.
    • (1989) Int J Pharm , vol.51 , pp. 9-17
    • Hintz, R.J.1    Johnson, K.C.2
  • 35
    • 73049134701 scopus 로고
    • Rate of release of medicaments from ointment bases containing drugs in suspension
    • Higuchi T. Rate of release of medicaments from ointment bases containing drugs in suspension. J Pharm Sci 1961; 50: 874-875.
    • (1961) J Pharm Sci , vol.50 , pp. 874-875
    • Higuchi, T.1
  • 36
    • 0014138173 scopus 로고
    • Establishment of sink conditions in dissolution rate determinations. Theoretical considerations and application to non-disintegrating dosage forms
    • Gibaldi M, Feldman S. Establishment of sink conditions in dissolution rate determinations. Theoretical considerations and application to non-disintegrating dosage forms. J Pharm Sci 1967; 56: 1238-1242.
    • (1967) J Pharm Sci , vol.56 , pp. 1238-1242
    • Gibaldi, M.1    Feldman, S.2
  • 37
    • 0030818251 scopus 로고    scopus 로고
    • A population growth model of dissolution
    • Dokoumetzidis A, Macheras P. A population growth model of dissolution. Pharm Res 1997; 14: 1122-1126.
    • (1997) Pharm Res , vol.14 , pp. 1122-1126
    • Dokoumetzidis, A.1    Macheras, P.2
  • 38
    • 0021904208 scopus 로고
    • Analysis of Fickian and non-Fickian drug release from polymers
    • Peppas NA. Analysis of Fickian and non-Fickian drug release from polymers. Pharm Acta Helv 1985; 60: 110-111.
    • (1985) Pharm Acta Helv , vol.60 , pp. 110-111
    • Peppas, N.A.1
  • 39
    • 0027159788 scopus 로고
    • Modelling S-shaped dissolution curves
    • Kervinen L, Yliruusi J. Modelling S-shaped dissolution curves. Int J Pharm 1993; 92: 115-122.
    • (1993) Int J Pharm , vol.92 , pp. 115-122
    • Kervinen, L.1    Yliruusi, J.2
  • 40
    • 18744422987 scopus 로고    scopus 로고
    • Shape modelling of dissolution profiles by non-integer kinetic orders
    • Jørgensen K, Christensen FN. Shape modelling of dissolution profiles by non-integer kinetic orders. Int J Pharm 1996; 143: 223-232.
    • (1996) Int J Pharm , vol.143 , pp. 223-232
    • Jørgensen, K.1    Christensen, F.N.2
  • 41
    • 0021043725 scopus 로고
    • Mathematical expression of tablet dissolution profiles
    • Leary JR, Ross SD. Mathematical expression of tablet dissolution profiles. Int J Pharm 1983; 17: 193-201.
    • (1983) Int J Pharm , vol.17 , pp. 193-201
    • Leary, J.R.1    Ross, S.D.2
  • 42
    • 0019785890 scopus 로고
    • Understanding the dose-effect relationship: Clinical application of pharmacokinetic-pharmacodynamic models
    • Holford NHG, Sheiner LB. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin Pharmacokinet 1981; 6: 429-453.
    • (1981) Clin Pharmacokinet , vol.6 , pp. 429-453
    • Holford, N.H.G.1    Sheiner, L.B.2
  • 43
    • 0031900490 scopus 로고    scopus 로고
    • Development and internal validation of an in vitro-in vivo correlation for hydrophilic metopro-lol tartrate extended release tablet formulation
    • Eddington ND, Marroum P, Uppoor R, Hussain A, Augsburger L. Development and internal validation of an in vitro-in vivo correlation for hydrophilic metopro-lol tartrate extended release tablet formulation. Pharm Res 1998; 15: 466-472.
    • (1998) Pharm Res , vol.15 , pp. 466-472
    • Eddington, N.D.1    Marroum, P.2    Uppoor, R.3    Hussain, A.4    Augsburger, L.5
  • 45
    • 0014592606 scopus 로고
    • Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules
    • Wagner JG. Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules. J Pharm Sci 1969; 58: 1253-1257.
    • (1969) J Pharm Sci , vol.58 , pp. 1253-1257
    • Wagner, J.G.1
  • 46
    • 0017852820 scopus 로고
    • On the methods of expressing dissolution rate data
    • Goldsmith JA, Randall N, Ross SD. On the methods of expressing dissolution rate data. J Pharm Pharmacol 1978; 30: 347-349.
    • (1978) J Pharm Pharmacol , vol.30 , pp. 347-349
    • Goldsmith, J.A.1    Randall, N.2    Ross, S.D.3
  • 47
    • 0015453518 scopus 로고
    • Linearization of dissolution curves by the Weibull distribution
    • Langenbucher F. Linearization of dissolution curves by the Weibull distribution. J Pharm Pharm 1972; 24: 979-981.
    • (1972) J Pharm Pharm , vol.24 , pp. 979-981
    • Langenbucher, F.1
  • 48
    • 0030472470 scopus 로고    scopus 로고
    • In vitro dissolution profile comparison: Statistics and analysis, model dependent approach
    • Sathe PM, Tsong Y, Shah VP. In vitro dissolution profile comparison: statistics and analysis, model dependent approach. Pharm Res 1996; 13: 1799-1803.
    • (1996) Pharm Res , vol.13 , pp. 1799-1803
    • Sathe, P.M.1    Tsong, Y.2    Shah, V.P.3
  • 49
    • 0030835412 scopus 로고    scopus 로고
    • In vitro dissolution profile comparison and IVIVR. Carbamazepine case
    • Sathe P, Tsong Y, Shah VP. In vitro dissolution profile comparison and IVIVR. Carbamazepine case. Adv Exp Med Biol 1997; 423: 31-42.
    • (1997) Adv Exp Med Biol , vol.423 , pp. 31-42
    • Sathe, P.1    Tsong, Y.2    Shah, V.P.3
  • 50
    • 0030976225 scopus 로고    scopus 로고
    • Multiple-time-point dissolution specification for a sampling acceptance plan
    • Chen JJ, Tsong Y. Multiple-time-point dissolution specification for a sampling acceptance plan. J Biopharm Stat 1997; 7: 259-270.
    • (1997) J Biopharm Stat , vol.7 , pp. 259-270
    • Chen, J.J.1    Tsong, Y.2
  • 51
    • 0023515116 scopus 로고
    • Analysis of in vitro dissolution of whole vs. half controlled-release theophylline tablets
    • Shah VP, Yamamoto LA, Schuirman D, Elkins J, Skelly JP. Analysis of in vitro dissolution of whole vs. half controlled-release theophylline tablets. Pharm Res 1987; 4: 416-419.
    • (1987) Pharm Res , vol.4 , pp. 416-419
    • Shah, V.P.1    Yamamoto, L.A.2    Schuirman, D.3    Elkins, J.4    Skelly, J.P.5
  • 52
    • 0015902704 scopus 로고
    • Use of statistical methods in evaluation of in vivo performance of dosage forms
    • Westlake WJ. Use of statistical methods in evaluation of in vivo performance of dosage forms. J Pharm Sci 1973; 62: 1579-1589.
    • (1973) J Pharm Sci , vol.62 , pp. 1579-1589
    • Westlake, W.J.1
  • 53
    • 0029825719 scopus 로고    scopus 로고
    • Statistical assessment of mean differences between two dissolution data sets
    • Tsong Y, Hammerstrom T, Sathe P, Shah VP. Statistical assessment of mean differences between two dissolution data sets. Drug Inf J 1996; 30: 1105-1112.
    • (1996) Drug Inf J , vol.30 , pp. 1105-1112
    • Tsong, Y.1    Hammerstrom, T.2    Sathe, P.3    Shah, V.P.4
  • 54
    • 0030998774 scopus 로고    scopus 로고
    • Statistical comparison between dissolution profiles of drug products
    • Chow SC, Ki FYC. Statistical comparison between dissolution profiles of drug products. J Biopharm Stat 1997; 7: 241-258.
    • (1997) J Biopharm Stat , vol.7 , pp. 241-258
    • Chow, S.C.1    Ki, F.Y.C.2
  • 55
    • 84993782399 scopus 로고    scopus 로고
    • On the assessment of similarity of drug dissolution profiles-a simulation study
    • Ju HL, Liaw SJ. On the assessment of similarity of drug dissolution profiles-a simulation study. Drug Inf J 1997; 31: 1273-1289.
    • (1997) Drug Inf J , vol.31 , pp. 1273-1289
    • Ju, H.L.1    Liaw, S.J.2
  • 56
    • 2342652446 scopus 로고    scopus 로고
    • Mathematical comparison of dissolution profiles
    • Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996; 6: 64-74.
    • (1996) Pharm Technol , vol.6 , pp. 64-74
    • Moore, J.W.1    Flanner, H.H.2
  • 57
    • 0029828547 scopus 로고    scopus 로고
    • Methods to compare dissolution profiles
    • Polli JE, Rekhi GS, Shah VP. Methods to compare dissolution profiles. Drug Inf J 1996; 30: 1113-1120.
    • (1996) Drug Inf J , vol.30 , pp. 1113-1120
    • Polli, J.E.1    Rekhi, G.S.2    Shah, V.P.3
  • 58
    • 0030696078 scopus 로고    scopus 로고
    • 2 as a criterion for assessment of similarity between dissolution profiles
    • 2 as a criterion for assessment of similarity between dissolution profiles. Drug Inf J 1997; 31: 1255-1271.
    • (1997) Drug Inf J , vol.31 , pp. 1255-1271
    • Liu, J.P.1    Ma, M.C.2    Chow, S.C.3
  • 61
    • 0026772726 scopus 로고
    • Bioequivalence
    • Rescigno A. Bioequivalence. Pharm Res 1992; 9: 925-928.
    • (1992) Pharm Res , vol.9 , pp. 925-928
    • Rescigno, A.1
  • 62
    • 0028948839 scopus 로고
    • Theoretical basis for a biophar-maceutics drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon GL, Lennernäs H, Shah VP, Crison JRA. Theoretical basis for a biophar-maceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995; 12: 413-420.
    • (1995) Pharm Res , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernäs, H.2    Shah, V.P.3    Crison, J.R.A.4
  • 63
    • 0031750861 scopus 로고    scopus 로고
    • Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs
    • Galia E, Nicolaides E, Hörter D, Löbenberg R, Reppas C, Dressman JB. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm Res 1998; 15: 698-705.
    • (1998) Pharm Res , vol.15 , pp. 698-705
    • Galia, E.1    Nicolaides, E.2    Hörter, D.3    Löbenberg, R.4    Reppas, C.5    Dressman, J.B.6
  • 65
    • 0030958197 scopus 로고    scopus 로고
    • The multivariate assessment of bioequivalence
    • Chinchilli VM, Elswick RK Jr. The multivariate assessment of bioequivalence. J Biopharm Stat 1997; 7: 113-123.
    • (1997) J Biopharm Stat , vol.7 , pp. 113-123
    • Chinchilli, V.M.1    Elswick, R.K.2
  • 66
    • 0030772854 scopus 로고    scopus 로고
    • Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence
    • Martson SA, Polli JE. Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence. Pharm Res 1997; 14: 1363-1369.
    • (1997) Pharm Res , vol.14 , pp. 1363-1369
    • Martson, S.A.1    Polli, J.E.2
  • 67
    • 85063550081 scopus 로고    scopus 로고
    • Physiologically based dissolution tests: Experience with two poorly soluble GlaxoWellcome drugs [abstr.]
    • Galia E, Nicolaides E, Efthymiopoulos C, Reppas C, Dressman JB. Physiologically based dissolution tests: experience with two poorly soluble GlaxoWellcome drugs [abstr.]. Pharm Res 1997; 14: S-491.
    • (1997) Pharm Res , vol.14 , pp. S-491
    • Galia, E.1    Nicolaides, E.2    Efthymiopoulos, C.3    Reppas, C.4    Dressman, J.B.5
  • 68
    • 0023038127 scopus 로고
    • Drug dissolution studies in milk using the automated flow injection serial dynamic dialysis technique
    • Macheras P, Koupparis M, Tsaprounis C. Drug dissolution studies in milk using the automated flow injection serial dynamic dialysis technique. Int J Pharm 1986; 33: 125-136.
    • (1986) Int J Pharm , vol.33 , pp. 125-136
    • Macheras, P.1    Koupparis, M.2    Tsaprounis, C.3


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