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Volumn 26, Issue 6, 2009, Pages 1289-1302

The science of USP 1 and 2 dissolution: Present challenges and future relevance

Author keywords

Biorelevant methods; Dissolution; In vitro in vivo correlation; Quality by design; Variability

Indexed keywords

APPARATUS; CALIBRATOR; CORRELATION ANALYSIS; DISSOLUTION; DRUG BLOOD LEVEL; DRUG DESIGN; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SCREENING; HYDRODYNAMICS; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW;

EID: 65549101635     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9822-x     Document Type: Review
Times cited : (110)

References (135)
  • 3
    • 65549135650 scopus 로고    scopus 로고
    • Measuring and Managing Method Variability
    • October 25, 2005, Rockville, MD, 1:184-219
    • L. Buhse. Measuring and Managing Method Variability. CDER Advisory Committee for Pharmaceutical Science, October 25, 2005, Rockville, MD, 1:184-219 (2005).
    • (2005) CDER Advisory Committee for Pharmaceutical Science
    • Buhse, L.1
  • 4
    • 55749101070 scopus 로고    scopus 로고
    • A new crescent-shaped spindle for drug dissolution testing-but why a new spindle?
    • S. A. Qureshi 2004 A new crescent-shaped spindle for drug dissolution testing-but why a new spindle? Dissolution Technol. 11 13 18
    • (2004) Dissolution Technol. , vol.11 , pp. 13-18
    • Qureshi, S.A.1
  • 5
    • 65549148960 scopus 로고    scopus 로고
    • Action plan for the development of scientifically based bioavailability and dissolution testing systems
    • Nov. 17, 2005, Piscataway, NJ (Rutgers Univ.)
    • F. J. Muzzio and P. Armenante. Action plan for the development of scientifically based bioavailability and dissolution testing systems. Presented at Drug Dissolution and Release Research Program Meeting, Nov. 17, 2005, Piscataway, NJ (Rutgers Univ.), pp. 1-10.
    • Presented at Drug Dissolution and Release Research Program Meeting , pp. 1-10
    • Muzzio, F.J.1    Armenante, P.2
  • 6
    • 65549138408 scopus 로고    scopus 로고
    • Dissolution Testing in the 21st Century, Hot Topic minutes
    • San Antonio, TX, Nov.1 Comments attributed to Ajaz Hussain (accessed 11/25/2008)
    • W. Swichtenberg. Dissolution Testing in the 21st Century, Hot Topic minutes. AAPS National Meeting, San Antonio, TX, Nov.1, 2006. Comments attributed to Ajaz Hussain. http://www.pharmamanufacturing.com/articles/2006/ 213.html (accessed 11/25/2008).
    • (2006) AAPS National Meeting
    • Swichtenberg, W.1
  • 7
    • 7944225198 scopus 로고    scopus 로고
    • Dissolution testing for solid oral drug products: Theoretical considerations
    • H. Zhang L. Yu 2004 Dissolution testing for solid oral drug products: Theoretical considerations J. Am. Pharm. Rev. 7 26 31 (Pubitemid 39468088)
    • (2004) American Pharmaceutical Review , vol.7 , Issue.5 , pp. 26-30
    • Zhang, H.1    Yu, L.X.2
  • 8
    • 57349152279 scopus 로고    scopus 로고
    • The concept of pharmaceutical quality
    • J. Woodcock 2004 The concept of pharmaceutical quality J. Am. Pharm. Rev. 7 10 15
    • (2004) J. Am. Pharm. Rev. , vol.7 , pp. 10-15
    • Woodcock, J.1
  • 9
    • 0017670012 scopus 로고
    • Factors influencing comparative bioavailability of spironolactone tablets
    • J. M. Clarke L. E. Ramsay J. R. Shelton M. J. Tidd S. Murray R. F. Palmer 1977 Factors influencing comparative bioavailability y of spironolactone tablets J. Pharm. Sci. 66 1429 1432 (Pubitemid 8184943)
    • (1977) Journal of Pharmaceutical Sciences , vol.66 , Issue.10 , pp. 1429-1432
    • Clarke, J.M.1    Ramsay, L.E.2    Shelton, J.R.3
  • 11
    • 3242754188 scopus 로고    scopus 로고
    • Shear distribution and variability in the USP Apparatus 2 under turbulent conditions
    • DOI 10.1016/j.ijpharm.2004.03.033, PII S0378517304002315
    • J. Kukura J. L. Baxter F. J. Muzzio 2004 Shear distribution and variability in the USP Apparatus 2 turbulent conditions Intl. J. Pharm. 279 9 17 (Pubitemid 38968637)
    • (2004) International Journal of Pharmaceutics , vol.279 , Issue.1-2 , pp. 9-17
    • Kukura, J.1    Baxter, J.L.2    Muzzio, F.J.3
  • 12
  • 14
    • 41549168738 scopus 로고    scopus 로고
    • Evaluation of the induced variance of physical parameters on the calibrated USP dissolution apparatus 1 and 2
    • B. Crist D. Spisak 2005 evaluation of the induced variance of physical parameters on the calibrated USP dissolution apparatus 1 and 2 Dissolution Technol. 12 28 31
    • (2005) Dissolution Technol. , vol.12 , pp. 28-31
    • Crist, B.1    Spisak, D.2
  • 15
    • 84974623989 scopus 로고    scopus 로고
    • Geometric irregularities common to the dissolution vessel
    • P. Scott 2005 Geometric irregularities common to the dissolution vessel Dissolution Technol. 12 18 21
    • (2005) Dissolution Technol. , vol.12 , pp. 18-21
    • Scott, P.1
  • 16
    • 84974539377 scopus 로고    scopus 로고
    • Observations of systemic errors in calibrator tablet testing
    • J. Burmicz 2005 Observations of systemic errors in calibrator tablet testing Dissolution Technol. 12 33 34
    • (2005) Dissolution Technol. , vol.12 , pp. 33-34
    • Burmicz, J.1
  • 17
    • 84974624200 scopus 로고    scopus 로고
    • USP dissolution calibrators: Re-examination and appraisal
    • T. Foster W. Brown 2005 USP dissolution calibrators: Re-examination and appraisal Dissolution Technol. 12 6 8
    • (2005) Dissolution Technol. , vol.12 , pp. 6-8
    • Foster, T.1    Brown, W.2
  • 18
    • 0028907748 scopus 로고
    • Evaluation of the performance of prednisone and salicylic acid USP dissolution calibrators
    • A. S. Achanta V. A. Gray T. L. Cecil L. T. Grady 1995 Evaluation of the performance of prednisone and salicylic acid USP dissolution calibrators Drug Dev. Ind. Pharm. 21 1171 1182
    • (1995) Drug Dev. Ind. Pharm. , vol.21 , pp. 1171-1182
    • Achanta, A.S.1    Gray, V.A.2    Cecil, T.L.3    Grady, L.T.4
  • 20
    • 84974601997 scopus 로고    scopus 로고
    • Evaluation of dissolution hydrodynamics in the USP, Peak™ and flat-bottom vessels using different solubility drugs
    • T. Mirza Y. Joshi Q. Liu R. Vivilecchia 2005 Evaluation of dissolution hydrodynamics in the USP, Peak™ and flat-bottom vessels using different solubility drugs Dissolution Technol. 12 11 16
    • (2005) Dissolution Technol. , vol.12 , pp. 11-16
    • Mirza, T.1    Joshi, Y.2    Liu, Q.3    Vivilecchia, R.4
  • 21
    • 0031913402 scopus 로고    scopus 로고
    • Dissolution testing as a prognostic tool for oral drug absorption: Immediate release dosage forms
    • DOI 10.1023/A:1011984216775
    • J. B. Dressman G. L. Amidon C. Reppas V. P. Shah 1998 Dissolution testing as a prognostic tool for oral drug absorption: Immediate release dosage forms Pharm. Res. 15 11 22 (Pubitemid 28080861)
    • (1998) Pharmaceutical Research , vol.15 , Issue.1 , pp. 11-22
    • Dressman, J.B.1    Amidon, G.L.2    Reppas, C.3    Shah, V.P.4
  • 22
    • 0017072750 scopus 로고
    • Effect of disintegrant type upon the relationship between compressional pressure and dissolution efficiency
    • K. Khan D. Rooke 1976 Effect of disintegrant type upon the relationship between compressional pressure and dissolution efficiency J. Pharm. Pharmacol. 28 633 636
    • (1976) J. Pharm. Pharmacol. , vol.28 , pp. 633-636
    • Khan, K.1    Rooke, D.2
  • 24
    • 0018072953 scopus 로고
    • Hardness increase induced by partial moisture loss in compressed tablets and its effect on in vitro dissolution
    • Z. Chowhan L. Palagyi 1978 Hardness increase induced by partial moisture loss in compressed tablets and its effect on in vitro dissolution J. Pharm. Sci. 67 1385 1389 (Pubitemid 9031058)
    • (1978) Journal of Pharmaceutical Sciences , vol.67 , Issue.10 , pp. 1385-1389
    • Chowhan, Z.T.1    Palagyi, L.2
  • 26
    • 0022637874 scopus 로고
    • Drug-excipient interactions resulting from powder mixing IV: Role of lubricants and their effect on in vitro dissolution
    • Z. Chowhan L. Chi 1986 Drug-excipient interactions resulting from powder mixing IV: Role of lubricants and their effect on in vitro dissolution J. Pharm. Sci. 75 542 545 (Pubitemid 16098034)
    • (1986) Journal of Pharmaceutical Sciences , vol.75 , Issue.6 , pp. 542-545
    • Chowhan, Z.T.1    Chi, L.-H.2
  • 27
    • 0024597887 scopus 로고
    • Changes of surface area in the dissolution process of crystalline substances. II. Dissolution and simulation curves for mixed systems of sieved particles
    • H. Sunada I. Shinohara A. Otsuka Y. Yonezawa 1989 Changes of surface area in the dissolution process of crystalline substances. II. Dissolution and simulation curves for mixed systems of sieved particles Chem. Pharm. Bull. 37 467 470 (Pubitemid 19082592)
    • (1989) Chemical and Pharmaceutical Bulletin , vol.37 , Issue.2 , pp. 467-470
    • Sunada, H.1    Shinohara, I.2    Otsuka, A.3    Yonezawa, Y.4
  • 28
    • 0002161631 scopus 로고
    • Factors affecting dissolution of drugs and their stability upon aging in solid dosage forms
    • Z. Chowhan 1994 Factors affecting dissolution of drugs and their stability upon aging in solid dosage forms Pharm. Technol. 18 60 73
    • (1994) Pharm. Technol. , vol.18 , pp. 60-73
    • Chowhan, Z.1
  • 29
    • 0344210384 scopus 로고    scopus 로고
    • Effect of aging on the dissolution stability of glibenclamide b-cyclodextrin complex
    • J. Babu J. Pandit 1999 Effect of aging on the dissolution stability of glibenclamide b-cyclodextrin complex Drug Dev. Ind. Pharm. 25 1215 1219
    • (1999) Drug Dev. Ind. Pharm. , vol.25 , pp. 1215-1219
    • Babu, J.1    Pandit, J.2
  • 30
    • 0032720026 scopus 로고    scopus 로고
    • Physico-chemical characterisation of the modifications i and II of (R,S) propranolol hydrochloride: Solubility and dissolution studies
    • DOI 10.1016/S0731-7085(99)00128-4, PII S0731708599001284
    • M. Bartolomei P. Bertocchi M. C. Ramusino N. Santucci L. Valvo 1999 Physico-chemical characterization of the modifications I and II of (R, S) propranolol hydrochloride: Solubility and dissolution studies J. Pharm. Biomed. Anal. 21 299 309 (Pubitemid 29502566)
    • (1999) Journal of Pharmaceutical and Biomedical Analysis , vol.21 , Issue.2 , pp. 299-309
    • Bartolomei, M.1    Bertocchi, P.2    Cotta Ramusino, M.3    Santucci, N.4    Valvo, L.5
  • 31
    • 0033008652 scopus 로고    scopus 로고
    • Effects of temperature and humidity on the physical properties of piroxicam tablets
    • N. Sarisuta T. Thamsakdakorn S. Jateleela 1999 Effects of temperature and humidity on the physical properties of piroxicam tablets Pharm. Technol. 23 66 80 (Pubitemid 29185688)
    • (1999) Pharmaceutical Technology , vol.23 , Issue.4
    • Sarisuta, N.1    Thamsakdakorn, T.2    Jateteela, S.3
  • 32
    • 0033403992 scopus 로고    scopus 로고
    • Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant
    • B. Rohrs T. Thamann P. Gao D. Stelzer M. Bergren R. Chao 1999 Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant Pharm. Res. 16 1850 1856 (Pubitemid 30040701)
    • (1999) Pharmaceutical Research , vol.16 , Issue.12 , pp. 1850-1856
    • Rohrs, B.R.1    Thamann, T.J.2    Gao, P.3    Stelzer, D.J.4    Bergren, M.S.5    Chao, R.S.6
  • 33
    • 0032968283 scopus 로고    scopus 로고
    • Effect of powder substrate on the dissolution properties of methyclothiazide liquisolid compacts
    • DOI 10.1081/DDC-100102156
    • S. Spireas T. Wang R. Grover 1999 Effects of Powder substrate on the dissolution properties of methyclothiazide liquisolid compacts Drug Dev. Ind. Pharm. 25 163 168 (Pubitemid 29072777)
    • (1999) Drug Development and Industrial Pharmacy , vol.25 , Issue.2 , pp. 163-168
    • Spireas, S.1    Wang, T.2    Grover, R.3
  • 34
    • 0041319207 scopus 로고    scopus 로고
    • Effects of breadfruit and cocoyam starch mucilage binders: On disintegration and dissolution behaviors of paracetamol tablet formulations
    • A. Adebayo O. Itiola 2003 Effects of breadfruit and cocoyam starch mucilage binders on disintegration and dissolution behaviors of paracetamol tablet formulations Pharm. Technol. 25 78 90 (Pubitemid 37101919)
    • (2003) Pharmaceutical Technology , vol.27 , Issue.3 , pp. 78-90
    • Adebayo, A.S.1    Itiola, O.A.2
  • 35
    • 23244466911 scopus 로고    scopus 로고
    • Controlled-release matrix tablets of ibuprofen using cellulose ethers and carrageenans: Effect of formulation factors on dissolution rates
    • DOI 10.1016/j.ejpb.2005.03.003, PII S0939641105001098
    • J. Nerurkar H. Jun J. Price M. Park 2005 Controlled-release matrix tablets of ibuprofen using cellulose ethers and carrageenans: Effect of formulation factors on dissolution rates Eur. J. Pharm. Biopharm. 61 56 68 (Pubitemid 41096689)
    • (2005) European Journal of Pharmaceutics and Biopharmaceutics , vol.61 , Issue.1-2 , pp. 56-68
    • Nerurkar, J.1    Jun, H.W.2    Price, J.C.3    Park, M.O.4
  • 36
    • 28444459242 scopus 로고    scopus 로고
    • Effects of formulation and process variables on the release of a weakly basic drug from single unit extended release formulations
    • DOI 10.1016/j.ejpb.2005.07.003, PII S0939641105002043
    • H. Kranz T. Wagner 2006 Effects of formulation and process variables on the release of a weakly basic drug from single unit extended release formulations Eur. J. Pharm. Biopharm. 62 70 76 (Pubitemid 41736027)
    • (2006) European Journal of Pharmaceutics and Biopharmaceutics , vol.62 , Issue.1 , pp. 70-76
    • Kranz, H.1    Wagner, T.2
  • 37
    • 28444498145 scopus 로고    scopus 로고
    • Study of formulation variables influencing the drug release rate from matrix tablets by experimental design
    • DOI 10.1016/j.ejpb.2005.07.001, PII S0939641105001980
    • S. Furlanetto M. Cirri F. Maestrelli G. Corti P. Mura 2006 Study of formulation variables influencing the drug release rate from matrix tablets by experimental design Eur. J. Pharm. Biopharm. 62 77 84 (Pubitemid 41736028)
    • (2006) European Journal of Pharmaceutics and Biopharmaceutics , vol.62 , Issue.1 , pp. 77-84
    • Furlanetto, S.1    Cirri, M.2    Maestrelli, F.3    Corti, G.4    Mura, P.5
  • 38
    • 65549106324 scopus 로고    scopus 로고
    • Comparison of acrylic and cellulose-based matrix formers for sustained drug release
    • D. G. Alvarez 2006 Comparison of acrylic and cellulose-based matrix formers for sustained drug release Drug Deliv. Technol. 6 61 65
    • (2006) Drug Deliv. Technol. , vol.6 , pp. 61-65
    • Alvarez, D.G.1
  • 39
    • 33747373878 scopus 로고    scopus 로고
    • A century of dissolution research: From Noyes and Whitney to the Biopharmaceutics Classification System
    • DOI 10.1016/j.ijpharm.2006.07.011, PII S0378517306005813
    • A. Dokoumetzidis P. Macheras 2006 A century of dissolution research: From Noyes and Whitney to the Biopharmaceutics Classification System Int. J. Pharm. 321 1 11 (Pubitemid 44247428)
    • (2006) International Journal of Pharmaceutics , vol.321 , Issue.1-2 , pp. 1-11
    • Dokoumetzidis, A.1    MacHeras, P.2
  • 40
    • 0003428589 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research US Government Printing Office, Rockville, MD
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Dissolution testing of immediate release dosage forms: Guidance for industry. US Government Printing Office, Rockville, MD, 1997.
    • (1997) Dissolution Testing of Immediate Release Dosage Forms: Guidance for Industry
  • 41
    • 0041692636 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research US Government Printing Office, Rockville, MD
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Q1A(R2) stability testing of new drug substances and products: Guidance for industry. US Government Printing Office, Rockville, MD, 2003.
    • (2003) Q1A(R2) Stability Testing of New Drug Substances and Products: Guidance for Industry
  • 43
    • 0037057305 scopus 로고    scopus 로고
    • Effect of moisture on polyvinylpyrrolidone in accelerated stability testing
    • DOI 10.1016/S0378-5173(02)00375-7, PII S0378517302003757
    • S. Fitzpatrick J. F. McCabe C. R. Petts S. W. Booth 2002 Effect of moisture on polyvinylpyrrolidone in accelerated stability testing Int. J. Pharm. 246 143 151 (Pubitemid 35247987)
    • (2002) International Journal of Pharmaceutics , vol.246 , Issue.1-2 , pp. 143-151
    • Fitzpatrick, S.1    McCabe, J.F.2    Petts, C.R.3    Booth, S.W.4
  • 44
    • 0030724408 scopus 로고    scopus 로고
    • Polymorphism in anhydrous theophylline - Implications on the dissolution rate of theophylline tablets
    • DOI 10.1021/js9701418
    • N. V. Phadnis R. Suryanarayanan 1997 Polymorphism in anhydrous theophylline-Implications on the dissolution rate of theophylline tablets J. Pharm. Sci. 86 1256 1263 (Pubitemid 27486097)
    • (1997) Journal of Pharmaceutical Sciences , vol.86 , Issue.11 , pp. 1256-1263
    • Phadnis, N.V.1    Suryanarayanan, R.2
  • 45
    • 0038182089 scopus 로고    scopus 로고
    • Cross-linking of hard gelatin carbamazepine capsules: Effect of dissolution conditions on in vitro drug release
    • DOI 10.1016/S0928-0987(03)00070-8
    • H. Marchais G. Cayzeele J. Y. Legendre M. Skiba P. Arnaud 2003 Cross-linking of hard gelatin carbamazepine capsules: Effect of dissolution conditions on in vitro drug release Eur. J. Pharm. Sci. 19 129 132 (Pubitemid 36668039)
    • (2003) European Journal of Pharmaceutical Sciences , vol.19 , Issue.2-3 , pp. 129-132
    • Marchais, H.1    Cayzeele, G.2    Legendre, J.-Y.3    Skiba, M.4    Arnaud, P.5
  • 49
    • 0034731684 scopus 로고    scopus 로고
    • Guidance on Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances
    • International Conference on Harmonization
    • International Conference on Harmonization. Guidance on Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances, Federal Register 65(251), 83041-83063 (2000).
    • (2000) Federal Register , vol.65 , Issue.251 , pp. 83041-83063
  • 50
    • 0031864961 scopus 로고    scopus 로고
    • A review of methods used to compare dissolution profile data
    • DOI 10.1016/S1461-5347(98)00053-4, PII S1461534798000534
    • T. O'Hara A. Dunne J. Butler J. Devane 1998 A review of methods used to compare dissolution profile data Pharm. Sci. Technol. Today 1 214 223 (Pubitemid 28387122)
    • (1998) Pharmaceutical Science and Technology Today , vol.1 , Issue.5 , pp. 214-223
    • O'Hara, T.1    Dunne, A.2    Butler, J.3    Devane, J.4
  • 51
    • 2342652446 scopus 로고    scopus 로고
    • Mathematical Comparison of Dissolution Profiles
    • J. W. Moore H. H. Flanner 1996 Mathematical comparison of dissolution profiles Pharm. Technol. 20 64 74 (Pubitemid 126450495)
    • (1996) Pharmaceutical Technology , vol.20 , Issue.6 , pp. 64-74
    • Moore, J.W.1    Flanner, H.H.2
  • 53
    • 0033271186 scopus 로고    scopus 로고
    • Statistical evaluations of dissolution similarity
    • M. Ma R. Lin J. Liu 1999 Statistical evaluations of dissolution similarity Stat. Sin. 9 1011 1027
    • (1999) Stat. Sin. , vol.9 , pp. 1011-1027
    • Ma, M.1    Lin, R.2    Liu, J.3
  • 54
    • 0035806261 scopus 로고    scopus 로고
    • An alternative method to the evaluation of similarity factor in dissolution testing
    • DOI 10.1016/S0378-5173(01)00651-2, PII S0378517301006512
    • P. Costa 2001 An alternative method to the evaluation of similarity factor in dissolution testing Int. J. Pharm. 220 77 83 (Pubitemid 32476843)
    • (2001) International Journal of Pharmaceutics , vol.220 , Issue.1-2 , pp. 77-83
    • Costa, P.1
  • 56
    • 0030472470 scopus 로고    scopus 로고
    • In-vitro dissolution profile comparison: Statistics and analysis, model dependent approach
    • DOI 10.1023/A:1016020822093
    • P. Sathe Y. Tsong V. P. Shah 1996 In vitro dissolution profile comparison-Statistics and analysis, model dependent approach Pharm. Res. 13 2 1799 1803 (Pubitemid 27034110)
    • (1996) Pharmaceutical Research , vol.13 , Issue.12 , pp. 1799-1803
    • Sathe, P.M.1    Tsong, Y.2    Shah, V.P.3
  • 58
    • 0030738943 scopus 로고    scopus 로고
    • Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis
    • Y. Tsong T. Hammerstrom J. Chen 1997 Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis J. Biopharm. Stat. 7 3 423 439 (Pubitemid 27326809)
    • (1997) Journal of Biopharmaceutical Statistics , vol.7 , Issue.3 , pp. 423-439
    • Tsong, Y.1    Hammerstrom, T.2    Chen, J.J.3
  • 59
    • 0342601356 scopus 로고    scopus 로고
    • On the assessment of similarity of drug dissolution profiles - A simulation study
    • H. J. Ju S.-J. Liaw 1997 On the assessment of similarity of drug dissolution profiles-A simulation study Drug Info. J. 31 1273 1289 (Pubitemid 27509632)
    • (1997) Drug Information Journal , vol.31 , Issue.4 , pp. 1273-1289
    • Lin Ju, H.1    Liaw, S.-J.2
  • 61
    • 15544386651 scopus 로고    scopus 로고
    • A multivariate test for similarity of two dissolution profiles
    • DOI 10.1081/BIP-200049832
    • H. Saranadasa K. Krishnamoorthy 2005 A multivariate test for similarity of two dissolution profiles J. Biopharm. Stat. 15 256 278 (Pubitemid 40404350)
    • (2005) Journal of Biopharmaceutical Statistics , vol.15 , Issue.2 , pp. 265-278
    • Saranadasa, H.1    Krishnamoorthy, K.2
  • 63
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutical drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • G. L. Amidon H. L. Lennernas V. P. Shah J. R. Crison 1995 A theoretical basis for a biopharmaceutical drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 413 420
    • (1995) Pharm. Res. , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.L.2    Shah, V.P.3    Crison, J.R.4
  • 65
    • 0030926727 scopus 로고    scopus 로고
    • Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets
    • DOI 10.1021/js960473x
    • J. E. Polli G. S. Rekhi L. L. Augsburger V. P. Shah 1997 Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets J. Pharm. Sci. 86 690 700 (Pubitemid 27248819)
    • (1997) Journal of Pharmaceutical Sciences , vol.86 , Issue.6 , pp. 690-700
    • Polli, J.E.1    Rekhi, G.S.2    Augsburger, L.L.3    Shah, V.P.4
  • 66
    • 15244341878 scopus 로고    scopus 로고
    • Identification of biowaivers among class II drugs: Theoretical justification and practical examples
    • DOI 10.1023/B:PHAM.0000041450.25106.c8
    • E. Rinaki A. Dokoumetzidis G. Valsami P. Macheras 2004 Identification of biowaivers among class II drugs: Theoretical justification and practical examples Pharm. Res. 21 1567 1572 (Pubitemid 41184386)
    • (2004) Pharmaceutical Research , vol.21 , Issue.9 , pp. 1567-1572
    • Rinaki, E.1    Dokoumetzidis, A.2    Valsami, G.3    MacHeras, P.4
  • 67
    • 0002915214 scopus 로고
    • In vitro/in vivo correlation for extended-release oral dosage forms
    • USP Subcommittee on Biopharmaceutics
    • USP Subcommittee on Biopharmaceutics 1988 In vitro/in vivo correlation for extended-release oral dosage forms Pharm. Forum 14 4 4160 4161
    • (1988) Pharm. Forum , vol.14 , Issue.4 , pp. 4160-4161
  • 69
    • 0004639823 scopus 로고
    • In vitro and in vivo evaluation of dosage forms
    • Pharmacopeial Forum
    • Pharmacopeial Forum. In vitro and in vivo evaluation of dosage forms. Pharm. Forum. 19(3):5366-5379 (1993).
    • (1993) Pharm. Forum , vol.19 , Issue.3 , pp. 5366-5379
  • 72
    • 41549126609 scopus 로고    scopus 로고
    • In vitro-In vivo correlation: From theory to applications
    • accessed 11/25/2008
    • J. Emami. In vitro-In vivo correlation: From theory to applications. J. Pharm. Pharmaceut. Sci. 9:169-189 (2006). http://www.ualberta.ca/~csps/JPPS9-2/ Jaber-Emami/MS-190.htm (accessed 11/25/2008).
    • (2006) J. Pharm. Pharmaceut. Sci , Issue.9 , pp. 169-189
    • Emami, J.1
  • 73
    • 0030806512 scopus 로고    scopus 로고
    • Convolution-based approaches for in vivo-in vitro correlation modeling
    • W. R. Gillespie. Convolution-based approaches for in vitro-in vivo correlation modeling. In D. Young, J. Devane, and J. Butler (eds.), In Vitro In Vivo Correlations, Vol. 423, Plenum, New York, 1997, pp. 53-65. (Pubitemid 27347192)
    • (1997) Advances in Experimental Medicine and Biology , vol.423 , pp. 53-65
    • Gillespie, W.R.1
  • 75
    • 2442462060 scopus 로고    scopus 로고
    • In vitro-in vivo correlation, definitions and regulatory guidance
    • N. Sirisuth N. D. Eddington 2002 In vitro-in vivo correlation, definitions and regulatory guidance Int. J. Generic Drugs. Part 2 1 11
    • (2002) Int. J. Generic Drugs. , Issue.PART 2 , pp. 1-11
    • Sirisuth, N.1    Eddington, N.D.2
  • 76
    • 0004234236 scopus 로고    scopus 로고
    • D. Young, J. G. Devane, and J. Butler (Eds.) Plenum, New York
    • D. Young, J. G. Devane, and J. Butler (Eds.), In Vitro In Vivo Correlations, Vol. 423, Plenum, New York, 1997.
    • (1997) In Vitro in Vivo Correlations , vol.423
  • 78
    • 0027195325 scopus 로고
    • In vitro-in vivo correlation for modified-release formulations
    • J. Drewe P. Guitard 1993 In vitro-in vivo correlation for modified-release formulations J. Pharm. Sci. 82 2 132 137 (Pubitemid 23147738)
    • (1993) Journal of Pharmaceutical Sciences , vol.82 , Issue.2 , pp. 132-137
    • Drewe, J.1    Guitard, P.2
  • 81
    • 33645503065 scopus 로고    scopus 로고
    • Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products cimetidine
    • E. Jantratid S. Prakongpan G. L. Amidon J. B. Dressman 2006 Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products cimetidine Clin. Pharmacokinet. 45 4 385 399
    • (2006) Clin. Pharmacokinet. , vol.45 , Issue.4 , pp. 385-399
    • Jantratid, E.1    Prakongpan, S.2    Amidon, G.L.3    Dressman, J.B.4
  • 82
    • 0036200128 scopus 로고    scopus 로고
    • Development and validation of a non-linear IVIVC model for a diltiazem extended release Formulation
    • DOI 10.1002/bdd.270
    • N. Sirisuth L. L. Augsburger N. D. Eddington 2002 Development and validation of a non-linear IVIVC model for a diltiazem extended release formulation Biopharm. Drug Disp. 23 1 8 (Pubitemid 34256937)
    • (2002) Biopharmaceutics and Drug Disposition , vol.23 , Issue.1 , pp. 1-8
    • Sirisuth, N.1    Augsburger, L.L.2    Eddington, N.D.3
  • 83
    • 0037436031 scopus 로고    scopus 로고
    • Development and validation of an in vitro-in vivo correlation for buspirone hydrochloride extended release tablets
    • DOI 10.1016/S0168-3659(02)00490-X
    • S. Takka A. Sakr A. Goldberg 2003 Development and validation of an in vitro-in vivo correlation for buspirone hydrochloride extended release tablets J. Control. Release 88 147 157 (Pubitemid 36173960)
    • (2003) Journal of Controlled Release , vol.88 , Issue.1 , pp. 147-157
    • Takka, S.1    Sakr, A.2    Goldberg, A.3
  • 84
    • 27644563437 scopus 로고    scopus 로고
    • Once-a-day extended-release dosage form of divalproex sodium III: Development and validation of a level A in vitro-in vivo correlation (IVIVC)
    • DOI 10.1002/jps.20387
    • D. Sandeep Y. H. Qiu S. Emil G. L. Cao G. G. Richard 2005 Once-a-day extended-release dosage form of divalproex sodium III: Development and validation of a level A in vitro-in vivo correlation (IVIVC) J. Pharm Sci. 94 9 1949 1956 (Pubitemid 41551479)
    • (2005) Journal of Pharmaceutical Sciences , vol.94 , Issue.9 , pp. 1949-1956
    • Dutta, S.1    Qiu, Y.2    Samara, E.3    Cao, G.4    Granneman, G.R.5
  • 85
    • 0034888569 scopus 로고    scopus 로고
    • In vitro-In vivo correlation (IVIVC) models for metformin after administration of modified-release (MR) oral dosage forms to healthy human volunteers
    • DOI 10.1002/jps.1071
    • G. Balan P. Timmins D. S. Greene P. H. Marathe 2001 In vitro-in vivo correlation (IVIVC) models for metformin after administration of modified-release (MR) oral dosage forms to healthy human volunteers J. Pharm. Sci. 90 8 1176 1185 (Pubitemid 32776999)
    • (2001) Journal of Pharmaceutical Sciences , vol.90 , Issue.8 , pp. 1176-1185
    • Redenti, E.1    Szente, L.2    Szejtli, J.3
  • 87
    • 67049162366 scopus 로고    scopus 로고
    • IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system
    • doi: 10.1002/jps.21576
    • P. Buch, P. Langguth, M. Kataoka, S. Yamashita. IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system. J. Pharm. Sci. Published online in Wiley InterScience ( www.interscience.wiley. com ). doi: 10.1002/jps.21576 .
    • J. Pharm. Sci. Published Online in Wiley InterScience
    • Buch, P.1    Langguth, P.2    Kataoka, M.3    Yamashita, S.4
  • 90
    • 0033759666 scopus 로고    scopus 로고
    • Carbamazepine level A in vivo-in vitro correlation (IVIVC): A scaled convolution based predictive approach
    • P. Veng-Pedersen J. V. S. Gobburu M. C. Meyer A. B. Straughn 2000 Carbamazepine level A in vivo-in vitro correlation (IVIVC): A scaled convolution based predictive approach Biopharm. Drug Dispos. 21 1 1 6
    • (2000) Biopharm. Drug Dispos. , vol.21 , Issue.1 , pp. 1-6
    • Veng-Pedersen, P.1    Gobburu, J.V.S.2    Meyer, M.C.3    Straughn, A.B.4
  • 93
    • 33947163024 scopus 로고    scopus 로고
    • A novel in vitro release method for submicron-sized dispersed system
    • N. Chidambaram D. J.. Burgess 1999 A novel in vitro release method for submicron-sized dispersed system AAPS PharmSci. 1 3 32 40
    • (1999) AAPS PharmSci. , vol.1 , Issue.3 , pp. 32-40
    • Chidambaram, N.1    Burgess, D.J.2
  • 94
    • 84962124081 scopus 로고    scopus 로고
    • IVIVR versus IVIVC
    • J. E. Polli 2000 IVIVR versus IVIVC Dissolution Technol. 7 3 6 9
    • (2000) Dissolution Technol. , vol.7 , Issue.3 , pp. 6-9
    • Polli, J.E.1
  • 95
    • 0031938959 scopus 로고    scopus 로고
    • Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities
    • DOI 10.1023/A:1011992518592
    • J. E. Polli M. J. Ginski 1998 Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities Pharm. Res. 15 47 52 (Pubitemid 28080865)
    • (1998) Pharmaceutical Research , vol.15 , Issue.1 , pp. 47-52
    • Polli, J.E.1    Ginski, M.J.2
  • 96
    • 84962094390 scopus 로고    scopus 로고
    • Simplified biorelevant media for screening dissolution performance of poorly soluble drugs
    • T. Zoeller S. Klein 2007 Simplified biorelevant media for screening dissolution performance of poorly soluble drugs Dissolution Technol. 14 8 13
    • (2007) Dissolution Technol. , vol.14 , pp. 8-13
    • Zoeller, T.1    Klein, S.2
  • 100
    • 55749100414 scopus 로고    scopus 로고
    • Vibration measurements on dissolution systems and effects on dissolution of predisone tablets RS
    • S. Vangani T. Flick G. Tamayo R. Chiu N. Cauchon 2007 Vibration measurements on dissolution systems and effects on dissolution of predisone tablets RS Dissolution Technol. 14 1 6 14
    • (2007) Dissolution Technol. , vol.14 , Issue.1 , pp. 6-14
    • Vangani, S.1    Flick, T.2    Tamayo, G.3    Chiu, R.4    Cauchon, N.5
  • 101
    • 84962103849 scopus 로고    scopus 로고
    • Effect of the irregular inner shape of a glass vessel on prednisone dissolution results
    • M. Tanaka H. Fujiwara M. Fujiwara 2005 Effect of the irregular inner shape of a glass vessel on prednisone dissolution results Dissolution Technol. 12 4 15 19
    • (2005) Dissolution Technol. , vol.12 , Issue.4 , pp. 15-19
    • Tanaka, M.1    Fujiwara, H.2    Fujiwara, M.3
  • 103
    • 71649116235 scopus 로고    scopus 로고
    • Typical variability in dissolution testing and its qualification
    • N. Kaniwa 2002 Typical variability in dissolution testing and its qualification Pharm. Tech. Jpn. 18 105 111
    • (2002) Pharm. Tech. Jpn. , vol.18 , pp. 105-111
    • Kaniwa, N.1
  • 104
    • 0032923660 scopus 로고    scopus 로고
    • Typical variability in drug dissolution testing: Study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product
    • DOI 10.1016/S0928-0987(98)00034-7, PII S0928098798000347
    • S. A. Qureshi I. J. McGilveray 1999 Typical variability in drug dissolution testing: study USP and FDA calibrator tablets and a marketed drug (glibenclamide) product Eur. J. Pharm. Sci. 7 249 258 (Pubitemid 29015743)
    • (1999) European Journal of Pharmaceutical Sciences , vol.7 , Issue.3 , pp. 249-258
    • Qureshi, S.A.1    McGilveray, I.J.2
  • 105
    • 0020085526 scopus 로고
    • Systematic error associated with apparatus 2 of the USP dissolution test. USBN 0-12-088547-6II: Effects of deviations in vessel curvature from that of a sphere
    • D. C. Cox C. E. Wells W. B. Furnam T. S. Savage A. C. King 1982 Systematic error associated with apparatus 2 of the USP dissolution test. USBN 0-12-088547-6II: Effects of deviations in vessel curvature from that of a sphere J. Pharm. Sci. 71 395 399
    • (1982) J. Pharm. Sci. , vol.71 , pp. 395-399
    • Cox, D.C.1    Wells, C.E.2    Furnam, W.B.3    Savage, T.S.4    King, A.C.5
  • 106
    • 1342344166 scopus 로고    scopus 로고
    • Effect of Hydrodynamic Environment on Tablets Dissolution Rate
    • DOI 10.1081/PDT-120027415
    • Y. Wu D. O. Kildsig E. S. Ghaly 2004 Effect of hydrodynamic environment on tablets dissolution rate Pharm. Dev. Technol. 9 25 37 (Pubitemid 38250224)
    • (2004) Pharmaceutical Development and Technology , vol.9 , Issue.1 , pp. 25-37
    • Wu, Y.1    Kildsig, D.O.2    Ghaly, E.S.3
  • 107
    • 33646641003 scopus 로고    scopus 로고
    • Shear-induced variability in the United States Pharmacopeia Apparatus 2: Modifications to the existing system
    • J. L. Baxter J. Kukura F. J. Muzzio 2006 Shear-induced variability in the United States Pharmacopeia Apparatus 2: Modifications to the existing system AAPS J. 7 4 E857 E864
    • (2006) AAPS J. , vol.7 , Issue.4
    • Baxter, J.L.1    Kukura, J.2    Muzzio, F.J.3
  • 108
    • 29244489524 scopus 로고    scopus 로고
    • Evaluation of hydrodynamics in the basket dissolution apparatus using computational fluid dynamics-Dissolution rate implications
    • D. D'Arcy 2005 Evaluation of hydrodynamics in the basket dissolution apparatus using computational fluid dynamics-Dissolution rate implications Eur. J. Pharm. Sci. 27 2-3 259 267
    • (2005) Eur. J. Pharm. Sci. , vol.27 , Issue.2-3 , pp. 259-267
    • D'Arcy, D.1
  • 109
    • 23144456859 scopus 로고    scopus 로고
    • Computational fluid dynamics modeling of the paddle dissolution apparatus: Agitation rate, mixing patterns, and fluid velocities
    • Article 31
    • L. G. McCarthy, G. Bradley, J. C. Sexton, O. I. Corrigan, and A. M. Healy. Computational fluid dynamics modeling of the paddle dissolution apparatus: Agitation rate, mixing patterns, and fluid velocities. AAPS PharmSciTech. 5(2):Article 31 (2004).
    • (2004) AAPS PharmSciTech , vol.5 , Issue.2
    • McCarthy, L.G.1    Bradley, G.2    Sexton, J.C.3    Corrigan, O.I.4    Healy, A.M.5
  • 110
    • 0141652948 scopus 로고    scopus 로고
    • Simulating the hydrodynamic conditions in the United States Pharmacopeia paddle dissolution apparatus
    • Article 22
    • L. G. McCarthy, C. Kosiol, A. M. Healy, G. Bradley, J. C. Sexton, and O. I. Corrigan. Simulating the hydrodynamic conditions in the United States Pharmacopeia paddle dissolution apparatus. AAPS PharmSciTech. 4(2):Article 22 (2003).
    • (2003) AAPS PharmSciTech , vol.4 , Issue.2
    • McCarthy, L.G.1    Kosiol, C.2    Healy, A.M.3    Bradley, G.4    Sexton, J.C.5    Corrigan, O.I.6
  • 112
    • 0033674245 scopus 로고    scopus 로고
    • Cause of high variability in drug dissolution testing and its impact on setting tolerances
    • S. A. Qureshi J. Shabnam 2001 Cause of high variability in drug dissolution testing and its impact on setting tolerances Eur. J. Pharm. Sci. 12 271 276
    • (2001) Eur. J. Pharm. Sci. , vol.12 , pp. 271-276
    • Qureshi, S.A.1    Shabnam, J.2
  • 114
    • 84962062605 scopus 로고    scopus 로고
    • Comparative evaluation of mixing dynamics in USP Apparatus 2 using standard USP vessels and PEAK™ vessels
    • C. Collins R. Nair 1998 Comparative evaluation of mixing dynamics in USP Apparatus 2 using standard USP vessels and PEAK™ vessels Dissolution Technol. 5 2 17 21
    • (1998) Dissolution Technol. , vol.5 , Issue.2 , pp. 17-21
    • Collins, C.1    Nair, R.2
  • 115
    • 0002337172 scopus 로고    scopus 로고
    • Improved hydrodynamics for USP Apparatus 2
    • A. H. Beckett, T. T. Quach, and G. S. Kurs. Improved hydrodynamics for USP Apparatus 2. Dissolution Technol. 3:7-10, 18 (1996).
    • (1996) Dissolution Technol , vol.3 , Issue.7-10 , pp. 18
    • Beckett, A.H.1    Quach, T.T.2    Kurs, G.S.3
  • 116
    • 84962074763 scopus 로고    scopus 로고
    • Comparative impact of stirring and shearing in drug dissolution testing with USP paddle and crescent-shaped spindles
    • S. A. Qureshi 2006 Comparative impact of stirring and shearing in drug dissolution testing with USP paddle and crescent-shaped spindles Dissolution Technol. 13 25 30
    • (2006) Dissolution Technol. , vol.13 , pp. 25-30
    • Qureshi, S.A.1
  • 117
    • 0343579306 scopus 로고    scopus 로고
    • Mega paddle - A recommendation to modify apparatus 2 used in the usp general test for dissolution (711)
    • M. S. F. Ross M. Rasis 1998 Mega paddle-A recommendation to modify Apparatus 2 used in the USP general test for dissolution <711> Pharm. Forum 24 214 (Pubitemid 128788805)
    • (1998) Pharmacopeial Forum , vol.24 , Issue.3 , pp. 6351-6353
    • Ross, M.S.F.1    Rasis, M.2
  • 122
    • 17344382083 scopus 로고    scopus 로고
    • Use of statistical experimental design in the further development of a discriminating in vitro release test for ethyl cellulose ER-coated spheres of remoxipride
    • DOI 10.1016/0928-0987(95)00033-X
    • C. Graffner M. Sarkela K. Gjellan G. Nork 1996 Use of statistical experimental design in the further development of a discriminating in vitro release test for ethyl cellulose ER-coated spheres of remoxipride Eur. J. Pharm. Sci. 4 73 83 (Pubitemid 26096222)
    • (1996) European Journal of Pharmaceutical Sciences , vol.4 , Issue.2 , pp. 73-83
    • Graffner, C.1    Sarkela, M.2    Gjellan, K.3    Nork, G.4
  • 124
    • 0033988302 scopus 로고    scopus 로고
    • Captopril gastrointestinal therapeutic system coated with cellulose acetate pseudolatex: Evaluation of main effects of several formulation variables
    • DOI 10.1016/S0378-5173(99)00324-5, PII S0378517399003245
    • M. A. Khan S. V. Sastry S. R. Vaithiyalingam V. Agarwal S. Nazzal I. K. Reddy 2000 Captopril gastrointestinal therapeutic system coated with cellulose acetate pseudolatex: Evaluation of main effects of several formulation variables Int. J. Pharm. 193 147 156 (Pubitemid 30001857)
    • (2000) International Journal of Pharmaceutics , vol.193 , Issue.2 , pp. 147-156
    • Khan, M.A.1    Sastry, S.V.2    Vaithiyalingam, S.R.3    Agarwal, V.4    Nazzal, S.5    Reddy, I.K.6
  • 126
    • 0028891911 scopus 로고
    • Determination of film-coated tablet parameters by near-infrared spectroscopy
    • J. D. Kirsch J. K. Drennen 1995 Determination of film-coated tablet parameters by near-infrared spectroscopy J. Pharm. Biomed. Anal. 13 1273 1281
    • (1995) J. Pharm. Biomed. Anal. , vol.13 , pp. 1273-1281
    • Kirsch, J.D.1    Drennen, J.K.2
  • 128
    • 33750026177 scopus 로고    scopus 로고
    • A process analytical technology approach based on near infrared spectroscopy: Tablet hardness, content uniformity, and dissolution test measurements of intact tablets
    • DOI 10.1002/jps.20653
    • M. Blanco M. Alcalá J. M. González E. Torras 2007 A process analytical technology approach based on near infrared spectroscopy: Tablet hardness, content uniformity, and dissolution test measurements of intact tablets J. Pharm. Sci. 95 2137 2144 (Pubitemid 44568525)
    • (2006) Journal of Pharmaceutical Sciences , vol.95 , Issue.10 , pp. 2137-2144
    • Blanco, M.1    Alcala, M.2    Gonzalez, J.M.3    Torras, E.4
  • 130
    • 65549106325 scopus 로고    scopus 로고
    • Biopharmaceutics and drug product quality: Performance tests for drug products, a look into the future
    • Iselin, NJ, Sept. 26
    • A. S. Hussain. Biopharmaceutics and drug product quality: Performance tests for drug products, a look into the future. USP Annual Scientific Meeting: The Science of Quality, Iselin, NJ, Sept. 26, 2004.
    • (2004) USP Annual Scientific Meeting: The Science of Quality
    • Hussain, A.S.1
  • 132
    • 65549100927 scopus 로고    scopus 로고
    • The dissolution procedure: Development and validation <1092>
    • United States Pharmacopeial Convention, Inc., Rockville, MD
    • The dissolution procedure: Development and validation <1092>. In The United States Pharmacopeia USP 30, United States Pharmacopeial Convention, Inc., Rockville, MD, 2007.
    • (2007) The United States Pharmacopeia USP 30
  • 133
    • 0005036122 scopus 로고    scopus 로고
    • Assay validation: Ruggedness and robustness with designed experiments
    • L. D. Torbeck 1996 Assay validation: Ruggedness and robustness with designed experiments Pharm:Technol. 20 169 172
    • (1996) Pharm:Technol. , vol.20 , pp. 169-172
    • Torbeck, L.D.1
  • 134
    • 65549099081 scopus 로고    scopus 로고
    • Robustness testing of an HPLC method using experimental design
    • P. A. Peters T. C. Paino 1999 Robustness testing of an HPLC method using experimental design Pharm. Technol., Anal. Valid. Suppl. 23 8 14
    • (1999) Pharm. Technol., Anal. Valid. Suppl. , vol.23 , pp. 8-14
    • Peters, P.A.1    Paino, T.C.2


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