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Volumn 96, Issue 1, 2007, Pages 27-37

Biowaiver monographs for immediate release solid oral dosage forms: Prednisolone

Author keywords

Absorption; Bioequivalence; Biopharmaceutics Classification System (BCS); Permeability; Prednisolone; Regulatory science; Solubility

Indexed keywords

PREDNISOLONE; PREDNISONE;

EID: 33846162254     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20768     Document Type: Note
Times cited : (71)

References (77)
  • 1
    • 3843072170 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms based on Biopharmaceutics Classification System (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol
    • Vogelpoel H, Welink J, Amidon GL, Junginger HE, Midha KK, Möller H, Olling M, Shah VP, Barends DM. 2004. Biowaiver monographs for immediate release solid oral dosage forms based on Biopharmaceutics Classification System (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol. J Pharm Sci 93:1945-1956.
    • (2004) J Pharm Sci , vol.93 , pp. 1945-1956
    • Vogelpoel, H.1    Welink, J.2    Amidon, G.L.3    Junginger, H.E.4    Midha, K.K.5    Möller, H.6    Olling, M.7    Shah, V.P.8    Barends, D.M.9
  • 2
    • 33749252978 scopus 로고    scopus 로고
    • WHO, 14th edition. Available from URL
    • WHO. 2005. Model list of essential medicines, 14th edition. Available from URL http://whqlibdoc. who.int/hq/2005/a87017_eng.pdf
    • (2005) Model list of essential medicines
  • 3
    • 85030526270 scopus 로고    scopus 로고
    • WHO. 2006. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URL http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.
    • WHO. 2006. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URL http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.
  • 5
    • 33646679648 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride
    • Manzo HR, Olivera ME, Amidon GL, Dressman JB, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride. J Pharm Sci 95:966-973.
    • (2006) J Pharm Sci , vol.95 , pp. 966-973
    • Manzo, H.R.1    Olivera, M.E.2    Amidon, G.L.3    Dressman, J.B.4    Barends, D.M.5
  • 6
    • 23844542010 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Chloroquine phosphate, chloroquine sulfate and chloroquine hydrochloride
    • Verbeeck RK, Junginger HE, Midha KK, Shah VP, Barends DM. 2005. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Chloroquine phosphate, chloroquine sulfate and chloroquine hydrochloride. J Pharm Sci 94:1389-1395.
    • (2005) J Pharm Sci , vol.94 , pp. 1389-1395
    • Verbeeck, R.K.1    Junginger, H.E.2    Midha, K.K.3    Shah, V.P.4    Barends, D.M.5
  • 10
    • 0021736426 scopus 로고
    • In vitro and in vivo bioequivalence of commercial prednisone tablets
    • Francisco GE, Honigberg IL, Stewart JT, et al. 1984. In vitro and in vivo bioequivalence of commercial prednisone tablets. Biopharm Drug Dispos 5:335-344.
    • (1984) Biopharm Drug Dispos , vol.5 , pp. 335-344
    • Francisco, G.E.1    Honigberg, I.L.2    Stewart, J.T.3
  • 11
    • 0018777782 scopus 로고
    • Clinical pharmacokinetics of prednisone and prednisolone
    • Pickup ME. 1979. Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokin 4:111-128.
    • (1979) Clin Pharmacokin , vol.4 , pp. 111-128
    • Pickup, M.E.1
  • 12
    • 85030516994 scopus 로고    scopus 로고
    • Online. Häßner K, editor. Frankfurt, Germany: Rote Liste Service GmbH, Available from URL
    • Rote Liste. 2004 Online. Häßner K, editor. Frankfurt, Germany: Rote Liste Service GmbH, Available from URL www.rote-liste.de
    • (2004)
    • Liste, R.1
  • 14
    • 0003841119 scopus 로고    scopus 로고
    • Cortisontherapie
    • 11. Auflage. Georg Thieme Verlag, Stuttgart, Germany
    • Kaiser H, Kley HK. 2002. Cortisontherapie. Corticoide in Klinik und Praxis. 11. Auflage. Georg Thieme Verlag, Stuttgart, Germany.
    • (2002) Corticoide in Klinik und Praxis
    • Kaiser, H.1    Kley, H.K.2
  • 15
    • 0028288388 scopus 로고
    • Perioperative glucocorticoid coverage. A reasessment 42 years after emergence of a problem
    • Salem M, Tainsh RE, Jr., Bromberg J, Loriaux DL, Chernow B. 1994. Perioperative glucocorticoid coverage. A reasessment 42 years after emergence of a problem. Ann Surg 219:416-425.
    • (1994) Ann Surg , vol.219 , pp. 416-425
    • Salem, M.1    Tainsh Jr., R.E.2    Bromberg, J.3    Loriaux, D.L.4    Chernow, B.5
  • 17
    • 0028958105 scopus 로고
    • A comparison of 'abruptly stopping' with 'tailing off' oral corticosteroids in acute asthma
    • Hatton MQF, Vathenen AS, Allen MJ, Davies S, Cooke NJ. 1995. A comparison of 'abruptly stopping' with 'tailing off' oral corticosteroids in acute asthma. Respir Med 89:101-104.
    • (1995) Respir Med , vol.89 , pp. 101-104
    • Hatton, M.Q.F.1    Vathenen, A.S.2    Allen, M.J.3    Davies, S.4    Cooke, N.J.5
  • 18
    • 0028292348 scopus 로고
    • Recovery of the hypothalamic-pituitary-adrenal axis from suppression by short-term, high-dose intravenous prednisolone therapy in patients with MS
    • Wenning GK, Wietholter H, Schnauder G, Muller PH, Kanduth S, Renn W. 1994. Recovery of the hypothalamic-pituitary-adrenal axis from suppression by short-term, high-dose intravenous prednisolone therapy in patients with MS. Acta Neurol Scand 89:270-273.
    • (1994) Acta Neurol Scand , vol.89 , pp. 270-273
    • Wenning, G.K.1    Wietholter, H.2    Schnauder, G.3    Muller, P.H.4    Kanduth, S.5    Renn, W.6
  • 19
    • 85030500501 scopus 로고    scopus 로고
    • USP 28-NF 23. 2005. The United States Pharmacopeia-The National Formulary. Rockville, MD: The United States Pharmacopeial Convention, Inc.
    • USP 28-NF 23. 2005. The United States Pharmacopeia-The National Formulary. Rockville, MD: The United States Pharmacopeial Convention, Inc.
  • 20
    • 80255126570 scopus 로고    scopus 로고
    • European Directorate for the Quality of Medicines, 5th edition. Strasbourg, France, European Directorate for the Quality of medicines, Council of Europe, Strasbourg, France
    • European Directorate for the Quality of Medicines. European pharmacopoeia, 5th edition. Strasbourg, France, European Directorate for the Quality of medicines, Council of Europe, Strasbourg, France.
    • European pharmacopoeia
  • 22
    • 0017334612 scopus 로고
    • Polymorphe und pseudopolymorphe Kristallformen von Steroidhormonen
    • Kuhnert-Brandstätter M. 1977. Polymorphe und pseudopolymorphe Kristallformen von Steroidhormonen. Pharm Ind 39:377-383.
    • (1977) Pharm Ind , vol.39 , pp. 377-383
    • Kuhnert-Brandstätter, M.1
  • 23
    • 0036174062 scopus 로고    scopus 로고
    • General solubility equation and the method using an amended salvation energy relationship
    • Yang G, Ran Y, Yalkowsky SH. 2002. General solubility equation and the method using an amended salvation energy relationship. J Pharm Sci 91:517-533.
    • (2002) J Pharm Sci , vol.91 , pp. 517-533
    • Yang, G.1    Ran, Y.2    Yalkowsky, S.H.3
  • 24
    • 0035470283 scopus 로고    scopus 로고
    • Prediction of aqueous solubility of organic compounds by the general solubility equation (gse)
    • Ran Y, Yalkowsky SH. 2001. Prediction of aqueous solubility of organic compounds by the general solubility equation (gse). J Chem Inf Comput Sci 41:1208-1217.
    • (2001) J Chem Inf Comput Sci , vol.41 , pp. 1208-1217
    • Ran, Y.1    Yalkowsky, S.H.2
  • 25
    • 0015304308 scopus 로고
    • Effect of complex formation on drug absorption XI: Complexation of prednisone and prednisolone with dialkylpropionamides and its effect on prednisone transfer through an artificial lipoid barrier
    • Hayton WL, Guttman DE, Levy G. 1972. Effect of complex formation on drug absorption XI: Complexation of prednisone and prednisolone with dialkylpropionamides and its effect on prednisone transfer through an artificial lipoid barrier. J Pharm Sci 61:356-361.
    • (1972) J Pharm Sci , vol.61 , pp. 356-361
    • Hayton, W.L.1    Guttman, D.E.2    Levy, G.3
  • 26
    • 33846138047 scopus 로고
    • Pharmaceutical applications and physiological aspects of solubilisation in solvent properties of surfactant solutions
    • Shinoda K, editor, New York: Dekker, pp
    • Sjoblom L. 1967. Pharmaceutical applications and physiological aspects of solubilisation in solvent properties of surfactant solutions. In: Shinoda K, editor. Solvent Properties of Surfactant Solutions. New York: Dekker, pp 189-247.
    • (1967) Solvent Properties of Surfactant Solutions , pp. 189-247
    • Sjoblom, L.1
  • 27
    • 16244386216 scopus 로고    scopus 로고
    • Comparison of the octanol/water partition coefficients calculated by ClogP®, ACDlogP and KowWin® to experimentally determined values
    • Machatha SG, Yalkowsky SH. 2005. Comparison of the octanol/water partition coefficients calculated by ClogP®, ACDlogP and KowWin® to experimentally determined values. Int J Pharm 294:185-192.
    • (2005) Int J Pharm , vol.294 , pp. 185-192
    • Machatha, S.G.1    Yalkowsky, S.H.2
  • 28
    • 0037331305 scopus 로고    scopus 로고
    • Physicochemical properties and transport of steroids across Caco-2 cells
    • Faassen F, Kelder J, Lenders J, Onderwater R, Vromans H. 2003. Physicochemical properties and transport of steroids across Caco-2 cells. Pharm Res 20:177-186.
    • (2003) Pharm Res , vol.20 , pp. 177-186
    • Faassen, F.1    Kelder, J.2    Lenders, J.3    Onderwater, R.4    Vromans, H.5
  • 30
    • 0017613114 scopus 로고
    • Effectiveness of prednisolone during phenytoin therapy
    • Petereit LB, Meikle AM. 1977. Effectiveness of prednisolone during phenytoin therapy. Clin Pharmacol Ther 22:912-916.
    • (1977) Clin Pharmacol Ther , vol.22 , pp. 912-916
    • Petereit, L.B.1    Meikle, A.M.2
  • 32
    • 0019176999 scopus 로고
    • Pharmacokinetics of intravenous and oral prednisolone
    • Al-Habet S, Rogers HJ. 1980. Pharmacokinetics of intravenous and oral prednisolone. Br J Clin Pharmacol 10:503-508.
    • (1980) Br J Clin Pharmacol , vol.10 , pp. 503-508
    • Al-Habet, S.1    Rogers, H.J.2
  • 33
    • 0020585653 scopus 로고
    • Pharmacokinetics and protein binding of prednisolone after oral and intravenous administration
    • Bergrem H, Grottum P, Rugstad HE. 1983. Pharmacokinetics and protein binding of prednisolone after oral and intravenous administration. Eur J Clin Pharmacol 24:415-419.
    • (1983) Eur J Clin Pharmacol , vol.24 , pp. 415-419
    • Bergrem, H.1    Grottum, P.2    Rugstad, H.E.3
  • 35
    • 0025302890 scopus 로고
    • Clinical pharmacokinetics of prednisone and prednisolone
    • Frey BM, Frey FJ. 1990. Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokinet 19:126-146.
    • (1990) Clin Pharmacokinet , vol.19 , pp. 126-146
    • Frey, B.M.1    Frey, F.J.2
  • 37
    • 0024255796 scopus 로고
    • Altered metabolism and decreased efficacy of prednisolone and prednisone in patients with hyperthyroidism
    • Frey FJ, Horber FF, Frey BM. 1988. Altered metabolism and decreased efficacy of prednisolone and prednisone in patients with hyperthyroidism. Clin Pharmacol Ther 44:510-521.
    • (1988) Clin Pharmacol Ther , vol.44 , pp. 510-521
    • Frey, F.J.1    Horber, F.F.2    Frey, B.M.3
  • 38
    • 0019810451 scopus 로고
    • Pharmacokinetics and endogenous hydrocortisone levels in cushingoid and non-cushingoid patients
    • Frey FJ, Amend WJC, Frey BM, Herford NHG, Benet LZ. 1981. Pharmacokinetics and endogenous hydrocortisone levels in cushingoid and non-cushingoid patients. Eur J Clin Pharmacol 21:235-242.
    • (1981) Eur J Clin Pharmacol , vol.21 , pp. 235-242
    • Frey, F.J.1    Amend, W.J.C.2    Frey, B.M.3    Herford, N.H.G.4    Benet, L.Z.5
  • 40
    • 0014213820 scopus 로고
    • Conversion of cortisone to cortisol and prednisone to prednisolone
    • Jenkins JS, Sampson PA. 1967. Conversion of cortisone to cortisol and prednisone to prednisolone. Br Med J 1:205-207.
    • (1967) Br Med J , vol.1 , pp. 205-207
    • Jenkins, J.S.1    Sampson, P.A.2
  • 41
    • 0015394082 scopus 로고
    • Corticosteroids in liver disease: Studies on the biological conversion of prednisone to prednisolone and plasma protein binding
    • Powell LW, Axelson E. 1972. Corticosteroids in liver disease: Studies on the biological conversion of prednisone to prednisolone and plasma protein binding. Gut 13:690-696.
    • (1972) Gut , vol.13 , pp. 690-696
    • Powell, L.W.1    Axelson, E.2
  • 44
    • 0019857278 scopus 로고
    • Dose dependent pharmacokinetics of prednisone and prednisolone in man
    • Rose JQ, Yurchak AM, Jusko WJ. 1981. Dose dependent pharmacokinetics of prednisone and prednisolone in man. J Pharmacokinet Biopharm 9:389-417.
    • (1981) J Pharmacokinet Biopharm , vol.9 , pp. 389-417
    • Rose, J.Q.1    Yurchak, A.M.2    Jusko, W.J.3
  • 45
    • 0016833196 scopus 로고
    • Absorption of enteric and non-enteric coated prednisolone tablets
    • Hulme B, James VH, Rault R. 1975. Absorption of enteric and non-enteric coated prednisolone tablets. Br J Clin Pharmacol 2:317-320.
    • (1975) Br J Clin Pharmacol , vol.2 , pp. 317-320
    • Hulme, B.1    James, V.H.2    Rault, R.3
  • 46
    • 0024443343 scopus 로고
    • Effect of food on the absorption and pharmacokinetics of prednisolone from enteric-coated tablets
    • Al-Habet S, Rogers HJ. 1989. Effect of food on the absorption and pharmacokinetics of prednisolone from enteric-coated tablets. Eur J Clin Pharmacol 37:423-426.
    • (1989) Eur J Clin Pharmacol , vol.37 , pp. 423-426
    • Al-Habet, S.1    Rogers, H.J.2
  • 47
    • 85030507709 scopus 로고    scopus 로고
    • Prokein R. 1982. Zur Pharmakokinetik des Prednisolons: Einfluss unterschiedlicher Kostformen auf die enterale Resorption. Inaugural- Dissertation, Görich & Weiershäuser Druck, Marburg.
    • Prokein R. 1982. Zur Pharmakokinetik des Prednisolons: Einfluss unterschiedlicher Kostformen auf die enterale Resorption. Inaugural- Dissertation, Görich & Weiershäuser Druck, Marburg.
  • 51
    • 0023445160 scopus 로고
    • Kinetics and dynamics of prednisolone
    • Frey FJ. 1987. Kinetics and dynamics of prednisolone. Endocr Rev 8:453-473.
    • (1987) Endocr Rev , vol.8 , pp. 453-473
    • Frey, F.J.1
  • 52
    • 0020361025 scopus 로고
    • The binding of prednisolone in human serum and to recrystallized human albumin in vitro
    • Steele WH, Hawksworth GM, Barber HE. 1982. The binding of prednisolone in human serum and to recrystallized human albumin in vitro. Br J Clin Pharmacol 14:667.
    • (1982) Br J Clin Pharmacol , vol.14 , pp. 667
    • Steele, W.H.1    Hawksworth, G.M.2    Barber, H.E.3
  • 53
    • 84905386411 scopus 로고    scopus 로고
    • Verlag. Heidelberg
    • HagerROM. 2001. Springer Verlag. Heidelberg.
    • (2001) Springer
    • HagerROM1
  • 54
    • 0034877516 scopus 로고    scopus 로고
    • The transfer of drugs and other chemical into human milk
    • American Academy of Pediatrics
    • American Academy of Pediatrics. 2001. The transfer of drugs and other chemical into human milk. Pediatrics 108:776-789.
    • (2001) Pediatrics , vol.108 , pp. 776-789
  • 56
    • 33846160636 scopus 로고
    • A comparative study of the metabolism of hydrocortisone and prednisolone
    • Nugent CA, Eik-nes K, Tyler FH. 1959. A comparative study of the metabolism of hydrocortisone and prednisolone. J Clin Endocrinol Metab 19:526-534.
    • (1959) J Clin Endocrinol Metab , vol.19 , pp. 526-534
    • Nugent, C.A.1    Eik-nes, K.2    Tyler, F.H.3
  • 57
    • 0017076664 scopus 로고
    • Steroid metabolism in adult lung
    • Hartiala J. 1976. Steroid metabolism in adult lung. Agents Actions 6:522-526.
    • (1976) Agents Actions , vol.6 , pp. 522-526
    • Hartiala, J.1
  • 58
    • 0002989821 scopus 로고
    • General pharmacology of glucocorticoids
    • Schleimer RP, Claman HN, Oronsky AL, editors, San Diego, California: Academic Press, Inc, pp
    • Szefler SJ. 1989. General pharmacology of glucocorticoids. In: Schleimer RP, Claman HN, Oronsky AL, editors. Anti-inflammatory steroid action basic and clinical aspects. San Diego, California: Academic Press, Inc, pp 353-376.
    • (1989) Anti-inflammatory steroid action basic and clinical aspects , pp. 353-376
    • Szefler, S.J.1
  • 61
    • 0027331597 scopus 로고
    • Pharmacokinetics of reversible metabolic systems
    • Cheng H, Jusko WJ. 1993. Pharmacokinetics of reversible metabolic systems. Biopharm Drug Dispos 14:721-766.
    • (1993) Biopharm Drug Dispos , vol.14 , pp. 721-766
    • Cheng, H.1    Jusko, W.J.2
  • 62
    • 85030509353 scopus 로고    scopus 로고
    • Morris HG. 1978. Pharmacology and corticosteroids in asthma. In: Middleton E, Jr., Reed C, Ellis E, editors. Allergy principles and practice. St. Louis: C.V. Mosby, pp 464-480.
    • Morris HG. 1978. Pharmacology and corticosteroids in asthma. In: Middleton E, Jr., Reed C, Ellis E, editors. Allergy principles and practice. St. Louis: C.V. Mosby, pp 464-480.
  • 63
    • 0016703003 scopus 로고
    • Effects of diphenylhydantoin, phenobarbital, and diazepam on the metabolism of methylprednisolone and its sodium succinate
    • Stjernholm MR, Katz FH. 1975. Effects of diphenylhydantoin, phenobarbital, and diazepam on the metabolism of methylprednisolone and its sodium succinate. J Clin Endocrinol Metab 41:887-893.
    • (1975) J Clin Endocrinol Metab , vol.41 , pp. 887-893
    • Stjernholm, M.R.1    Katz, F.H.2
  • 64
    • 0021222832 scopus 로고
    • Alterations in prednisolone disposition as a result of time of administration, gender and dose
    • Meffin PJ, Brooks PM, Sallustio BC. 1984. Alterations in prednisolone disposition as a result of time of administration, gender and dose. Br J Clin Pharmacol 17:394-404.
    • (1984) Br J Clin Pharmacol , vol.17 , pp. 394-404
    • Meffin, P.J.1    Brooks, P.M.2    Sallustio, B.C.3
  • 65
    • 0024498864 scopus 로고
    • Impact of ketoconazole on the metabolism of prednisolone
    • Zürcher RM, Frey BM, Frey FJ. 1989. Impact of ketoconazole on the metabolism of prednisolone. Clin Pharmacol Ther 45:366-372.
    • (1989) Clin Pharmacol Ther , vol.45 , pp. 366-372
    • Zürcher, R.M.1    Frey, B.M.2    Frey, F.J.3
  • 66
    • 0023758127 scopus 로고
    • Relative and absolute bioavailability of prednisone and prednisolone after separate oral and intravenous doses
    • Ferry JJ, Horvath AM, Bekersky I, Heath EC, Ryan CF, Colburn WA. 1988. Relative and absolute bioavailability of prednisone and prednisolone after separate oral and intravenous doses. J Clin Pharmacol 28:81-87.
    • (1988) J Clin Pharmacol , vol.28 , pp. 81-87
    • Ferry, J.J.1    Horvath, A.M.2    Bekersky, I.3    Heath, E.C.4    Ryan, C.F.5    Colburn, W.A.6
  • 67
    • 0021176103 scopus 로고
    • Alterations in prednisolone disposition as a result of oral contraceptive use and dose
    • Meffin PJ, Wing LM, Sallustio BC, et al. 1984. Alterations in prednisolone disposition as a result of oral contraceptive use and dose. Br J Clin Pharmacol 17:655-664.
    • (1984) Br J Clin Pharmacol , vol.17 , pp. 655-664
    • Meffin, P.J.1    Wing, L.M.2    Sallustio, B.C.3
  • 68
    • 85030500137 scopus 로고    scopus 로고
    • Available from URL
    • Fachinformation Decortin H 10 mg. Available from URL: http://www.fachinfo.de/data/fi/jsearch/viewPDF?wirkstoff&1819371871.
    • Fachinformation Decortin H 10 mg
  • 69
    • 85030520137 scopus 로고    scopus 로고
    • Available from URL
    • Fachinformation Prednisolon-ratiopharm Tabletten. Available from URL: http://www.fachinfo.de/data/fi/jsearch/viewPDF?wirkstoff&1988247025.
    • Tabletten
    • Prednisolon-ratiopharm, F.1
  • 70
    • 85030513998 scopus 로고    scopus 로고
    • Available from URL
    • Fachinformation Dermosolon. Available from URL: http://www.fachinfo.de/ data/fi/jsearch/viewPDF? wirkstoff&1988246888.
    • Fachinformation Dermosolon
  • 71
    • 0038023463 scopus 로고
    • The effects of some solid buffering agents in aqueous suspension on prednisolone
    • Chulski T, Forist AA. 1958. The effects of some solid buffering agents in aqueous suspension on prednisolone. J Am Pharm Assoc (Baltim) 47:553-555.
    • (1958) J Am Pharm Assoc (Baltim) , vol.47 , pp. 553-555
    • Chulski, T.1    Forist, A.A.2
  • 72
    • 0003455057 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER, based on a Biopharmaceutics Classification System. Available from URL
    • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). 2000. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. Available from URL: http://www.fda.gov/cder/guidance/ 3618fnl.pdf.
    • (2000) Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms
  • 74
    • 85030514441 scopus 로고    scopus 로고
    • WHO. 2006. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URL: http://whqlibdoc.who.int/ trs/WHO_TRS_937_eng.pdf.
    • WHO. 2006. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URL: http://whqlibdoc.who.int/ trs/WHO_TRS_937_eng.pdf.
  • 75
    • 3843097202 scopus 로고    scopus 로고
    • Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system
    • Lindenberg M, Kopp S, Dressman JB. 2004. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm 58:265-278.
    • (2004) Eur J Pharm Biopharm , vol.58 , pp. 265-278
    • Lindenberg, M.1    Kopp, S.2    Dressman, J.B.3
  • 76
    • 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
    • Wu CY, Benet LZ. 2005. Predicting drug disposition via application of BCS: Transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res 22:11-23.
    • (2005) Pharm Res , vol.22 , pp. 11-23
    • Wu, C.Y.1    Benet, L.Z.2
  • 77
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon GL, Lennernas H, Shah VP, Crison JR. 1995. 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) Pharm Res , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3    Crison, J.R.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.