메뉴 건너뛰기




Volumn 69, Issue 3, 2010, Pages 238-244

Assessing the bioequivalence of analogues of endogenous substances ('endogenous drugs'): Considerations to optimize study design

Author keywords

Bioequivalence; Endogenous drugs; Endogenous substances; Exogenous analogues

Indexed keywords

ESTRADIOL; ETHINYLESTRADIOL PLUS LYNESTRENOL; FOLLITROPIN; GOSERELIN; GROWTH HORMONE; LEVOTHYROXINE; LUTEINIZING HORMONE; POTASSIUM CHLORIDE; RECOMBINANT GROWTH HORMONE; SOMATOSTATIN; THYROTROPIN; THYROXINE;

EID: 76649131303     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03585.x     Document Type: Article
Times cited : (23)

References (30)
  • 1
    • 67649932264 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use. European Medicines Agency
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the Investigation of Bioequivalence (Draft). European Medicines Agency 2008.
    • (2008) Guideline on the Investigation of Bioequivalence (Draft)
  • 2
    • 0034467662 scopus 로고    scopus 로고
    • Consideration of endogenous backgrounds in pharmacokinetic analyses: A simulation study
    • Schindel F. Consideration of endogenous backgrounds in pharmacokinetic analyses: a simulation study. Eur J Clin Pharmacol 2000 56 : 685 688.
    • (2000) Eur J Clin Pharmacol , vol.56 , pp. 685-688
    • Schindel, F.1
  • 3
    • 0033888895 scopus 로고    scopus 로고
    • Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution
    • Jacobsen LV, Rolan P, Christensen MS, Knudsen KM, Rasmussen MH. Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution. Growth Horm IGF Res 2000 10 : 93 8.
    • (2000) Growth Horm IGF Res , vol.10 , pp. 93-8
    • Jacobsen, L.V.1    Rolan, P.2    Christensen, M.S.3    Knudsen, K.M.4    Rasmussen, M.H.5
  • 5
    • 42549113197 scopus 로고    scopus 로고
    • Bioequivalence of recombinant human FSH and recombinant human LH in a fixed 2 : 1111 combination: Two phase I, randomised, crossover studies
    • Picard M, Rossier C, Papasouliotis O, Lugan I. Bioequivalence of recombinant human FSH and recombinant human LH in a fixed 2 : 1 combination: two phase I, randomised, crossover studies. Curr Med Res Opin 2008 24 : 1199 1208.
    • (2008) Curr Med Res Opin , vol.24 , pp. 1199-1208
    • Picard, M.1    Rossier, C.2    Papasouliotis, O.3    Lugan, I.4
  • 6
    • 0032795629 scopus 로고    scopus 로고
    • Bioequivalence of subcutaneous injections of recombinant human follicle stimulating hormone (Puregon(R)) by Pen-injector and syringe
    • Voortman G, van de Post J, Schoemaker RC, van Gerven JM. Bioequivalence of subcutaneous injections of recombinant human follicle stimulating hormone (Puregon(R)) by Pen-injector and syringe. Hum Reprod 1999 14 : 1698 1702.
    • (1999) Hum Reprod , vol.14 , pp. 1698-1702
    • Voortman, G.1    Van De Post, J.2    Schoemaker, R.C.3    Van Gerven, J.M.4
  • 7
    • 0017079142 scopus 로고
    • Dose-dependent inhibition by oral contraceptives of the pituitary to release LH and FSH in response to stimulation with LH-RH+
    • Dericks-Tan JS, Krög W, Aktories K, Taubert HD. Dose-dependent inhibition by oral contraceptives of the pituitary to release LH and FSH in response to stimulation with LH-RH+. Contraception 1976 14 : 171 181.
    • (1976) Contraception , vol.14 , pp. 171-181
    • Dericks-Tan, J.S.1    Krög, W.2    Aktories, K.3    Taubert, H.D.4
  • 8
    • 0000422996 scopus 로고
    • Limitations of levothyroxine bioequivalence evaluation: Analysis of an attempted study
    • Mayor GH, Orlando T, Kurtz NM. Limitations of levothyroxine bioequivalence evaluation: analysis of an attempted study. Am J Ther 1995 2 : 417 432.
    • (1995) Am J Ther , vol.2 , pp. 417-432
    • Mayor, G.H.1    Orlando, T.2    Kurtz, N.M.3
  • 9
    • 0031721406 scopus 로고    scopus 로고
    • Pharmacokinetics of orally administered estradiol valerate. Results of a single-dose cross-over bioequivalence study in postmenopausal women
    • Zimmermann H, Koytchev R, Mayer O, Börner A, Mellinger U, Breitbarth H. Pharmacokinetics of orally administered estradiol valerate. Results of a single-dose cross-over bioequivalence study in postmenopausal women. Arzneimittelforschung 1998 48 : 941 947.
    • (1998) Arzneimittelforschung , vol.48 , pp. 941-947
    • Zimmermann, H.1    Koytchev, R.2    Mayer, O.3    Börner, A.4    Mellinger, U.5    Breitbarth, H.6
  • 10
    • 0035155791 scopus 로고    scopus 로고
    • Bioequivalence and relative bioavailability of three estradiol and norethisterone acetate-containing hormone replacement therapy tablets
    • Zdravkovic M, Müller M, Larsen S, Degenkolb J, Pabst G. Bioequivalence and relative bioavailability of three estradiol and norethisterone acetate-containing hormone replacement therapy tablets. Int J Clin Pharmacol Ther 2001 39 : 41 6.
    • (2001) Int J Clin Pharmacol Ther , vol.39 , pp. 41-6
    • Zdravkovic, M.1    Müller, M.2    Larsen, S.3    Degenkolb, J.4    Pabst, G.5
  • 12
    • 0029072276 scopus 로고
    • Multiple-dose pharmacokinetics and bioequivalence of l-carnitine 330-mg tablet vs. 1-g chewable tablet vs. enteral solution in healthy adult male volunteers
    • Sahajwalla CG, Helton ED, Purich ED, Hoppel CL, Cabana BE. Multiple-dose pharmacokinetics and bioequivalence of l-carnitine 330-mg tablet vs. 1-g chewable tablet vs. enteral solution in healthy adult male volunteers. J Pharm Sci 1995 84 : 627 633.
    • (1995) J Pharm Sci , vol.84 , pp. 627-633
    • Sahajwalla, C.G.1    Helton, E.D.2    Purich, E.D.3    Hoppel, C.L.4    Cabana, B.E.5
  • 14
    • 27644545773 scopus 로고    scopus 로고
    • Bioequivalence studies for levothyroxine
    • Bolton S. Bioequivalence studies for levothyroxine. AAPS J 2005 7 : E47 53.
    • (2005) AAPS J , vol.7 , pp. 47-53
    • Bolton, S.1
  • 16
    • 10044237745 scopus 로고    scopus 로고
    • Assessment of levothyroxine sodium bioavailability: Recommendations for an improved methodology based on the pooled analysis of eight identically designed trials with 396 drug exposures
    • Walter-Sack I, Clanget C, Ding R, Goeggelmann C, Hinke V, Lang M, Pfeilschifter J, Tayrouz Y, Wegscheider K. Assessment of levothyroxine sodium bioavailability: recommendations for an improved methodology based on the pooled analysis of eight identically designed trials with 396 drug exposures. Clin Pharmacokinet 2004 43 : 1037 1053.
    • (2004) Clin Pharmacokinet , vol.43 , pp. 1037-1053
    • Walter-Sack, I.1    Clanget, C.2    Ding, R.3    Goeggelmann, C.4    Hinke, V.5    Lang, M.6    Pfeilschifter, J.7    Tayrouz, Y.8    Wegscheider, K.9
  • 17
    • 27644542257 scopus 로고    scopus 로고
    • Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate
    • Blakesley VA. Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate. AAPS J 2005 7 : E42 6.
    • (2005) AAPS J , vol.7 , pp. 42-6
    • Blakesley, V.A.1
  • 19
    • 0029006622 scopus 로고
    • Acclimation of a non-indigenous sub-Artic population: Seasonal variation in thyroid function in interior Alaska
    • Levine M, Duffy L, Moore DC, Matej LA. Acclimation of a non-indigenous sub-Artic population: seasonal variation in thyroid function in interior Alaska. Comp Biochem Physiol A Physiol 1995 111 : 209 214.
    • (1995) Comp Biochem Physiol A Physiol , vol.111 , pp. 209-214
    • Levine, M.1    Duffy, L.2    Moore, D.C.3    Matej, L.A.4
  • 21
    • 0023393723 scopus 로고
    • Seasonal variation in thyroid size in healthy males
    • Hegedüs L, Rasmussen N, Knudsen N. Seasonal variation in thyroid size in healthy males. Horm Metab Res 1987 19 : 391 392.
    • (1987) Horm Metab Res , vol.19 , pp. 391-392
    • Hegedüs, L.1    Rasmussen, N.2    Knudsen, N.3
  • 23
    • 0032825293 scopus 로고    scopus 로고
    • Open questions on bioequivalence: Some problems and some solutions
    • Marzo A. Open questions on bioequivalence: some problems and some solutions. Pharmacol Res 1999 40 : 357 368.
    • (1999) Pharmacol Res , vol.40 , pp. 357-368
    • Marzo, A.1
  • 24
    • 0030894813 scopus 로고    scopus 로고
    • Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism
    • Dong BJ, Hauck WW, Gambertoglio JG, Gee L, White JR, Bubp JL, Greenspan FS. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 1997 277 : 1205 1213.
    • (1997) JAMA , vol.277 , pp. 1205-1213
    • Dong, B.J.1    Hauck, W.W.2    Gambertoglio, J.G.3    Gee, L.4    White, J.R.5    Bubp, J.L.6    Greenspan, F.S.7
  • 25
    • 0027408187 scopus 로고
    • Bioavailability studies of drugs with nonlinear pharmacokinetics: II. Absolute bioavailability of intravenous phenytoin prodrug at therapeutic phenytoin serum concentrations determined by double-stable isotope technique
    • Browne TR, Szabo GK, McEntegart C, Evans JE, Evans BA, Miceli JJ, Quon C, Dougherty CL, Kres J, Davoudi H. Bioavailability studies of drugs with nonlinear pharmacokinetics: II. Absolute bioavailability of intravenous phenytoin prodrug at therapeutic phenytoin serum concentrations determined by double-stable isotope technique. J Clin Pharmacol 1993 33 : 89 94.
    • (1993) J Clin Pharmacol , vol.33 , pp. 89-94
    • Browne, T.R.1    Szabo, G.K.2    McEntegart, C.3    Evans, J.E.4    Evans, B.A.5    Miceli, J.J.6    Quon, C.7    Dougherty, C.L.8    Kres, J.9    Davoudi, H.10
  • 27
    • 0033324606 scopus 로고    scopus 로고
    • Moricizine bioavailability via simultaneous, dual, stable isotope administration: Bioequivalence implications
    • Pieniaszek HJ Jr., Mayersohn M, Adams MP, Reinhart RJ, Barrett JS. Moricizine bioavailability via simultaneous, dual, stable isotope administration: bioequivalence implications. J Clin Pharmacol 1999 39 : 817 825.
    • (1999) J Clin Pharmacol , vol.39 , pp. 817-825
    • Pieniaszek Jr., H.J.1    Mayersohn, M.2    Adams, M.P.3    Reinhart, R.J.4    Barrett, J.S.5
  • 28
    • 0027938573 scopus 로고
    • Use of stable isotopes for evaluation of drug delivery systems: Comparison of ibuprofen release in vivo and in vitro from two biphasic release formulations utilizing different rate-controlling polymers
    • Theis DL, Lucisano LJ, Halstead GW. Use of stable isotopes for evaluation of drug delivery systems: comparison of ibuprofen release in vivo and in vitro from two biphasic release formulations utilizing different rate-controlling polymers. Pharm Res 1994 11 : 1069 1076.
    • (1994) Pharm Res , vol.11 , pp. 1069-1076
    • Theis, D.L.1    Lucisano, L.J.2    Halstead, G.W.3
  • 29
    • 0022639059 scopus 로고
    • The application of stable isotopes to studies of drug bioavailability and bioequivalence
    • Wolen RL. The application of stable isotopes to studies of drug bioavailability and bioequivalence. J Clin Pharmacol 1986 26 : 419 424.
    • (1986) J Clin Pharmacol , vol.26 , pp. 419-424
    • Wolen, R.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.