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Volumn 36, Issue 8, 1998, Pages 450-457

Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence

Author keywords

Benefits; Individual bioequivalence; Intraindividual variance; Penalties; Regulatory criteria; Simulated trials; Tradeoff relationship

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; PROBABILITY; SIMULATION; VARIANCE;

EID: 0031857671     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (17)

References (13)
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  • 3
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    • Chen ML 1997 Individual bioequivalence - a regulatory update. J Biopharm Stat 7: 5-11
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    • Chen, M.L.1
  • 4
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    • Some issues for the consideration of individual bioequivalence
    • Endrenyi L 1997 Some issues for the consideration of individual bioequivalence. J Biopharm Stat 7: 35-39
    • (1997) J Biopharm Stat , vol.7 , pp. 35-39
    • Endrenyi, L.1
  • 5
    • 0032189788 scopus 로고    scopus 로고
    • Individual bioequivalence - Has its time come?
    • in press
    • Endrenyi L, Midha KK 1998 Individual bioequivalence - has its time come? Eur J Pharm Sci in press
    • (1998) Eur J Pharm Sci
    • Endrenyi, L.1    Midha, K.K.2
  • 7
    • 0030909029 scopus 로고    scopus 로고
    • Discussion of individual bioequivalence by M.-L. Chen
    • Gould AL 1997 Discussion of individual bioequivalence by M.-L. Chen. J Biopharm Stat 7: 23-29
    • (1997) J Biopharm Stat , vol.7 , pp. 23-29
    • Gould, A.L.1
  • 9
    • 0030692734 scopus 로고    scopus 로고
    • Individual and average bioequivalence of highly variable drugs and drug products
    • Midha KK, Rawson MJ, Hubbard JW 1997 Individual and average bioequivalence of highly variable drugs and drug products. J Pharm Sci 86: 1193-1197
    • (1997) J Pharm Sci , vol.86 , pp. 1193-1197
    • Midha, K.K.1    Rawson, M.J.2    Hubbard, J.W.3
  • 10
    • 0030771117 scopus 로고    scopus 로고
    • Individual bioequivalence - New concepts in the statistical assessment of bioequivalence metrics
    • Patnaik RN, Lesko LJ, Chen ML, Williams RL 1997 Individual bioequivalence - new concepts in the statistical assessment of bioequivalence metrics. Clin Pharmacokinet 33: 1-6
    • (1997) Clin Pharmacokinet , vol.33 , pp. 1-6
    • Patnaik, R.N.1    Lesko, L.J.2    Chen, M.L.3    Williams, R.L.4
  • 11
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    • A unified view of individual, population, and average bioequivalence
    • Blume HH, Midha KK (eds): Medpharm, Stuttgart
    • Schall R 1995 A unified view of individual, population, and average bioequivalence. In: Blume HH, Midha KK (eds): Bio-International 2: Bioavailability, Bioequivalence and Pharmacokinetic Studies. Medpharm, Stuttgart, pp 91-106
    • (1995) Bio-International 2: Bioavailability, Bioequivalence and Pharmacokinetic Studies , pp. 91-106
    • Schall, R.1
  • 12
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • Schall R, Luus HE 1993 On population and individual bioequivalence. Stat Med 12: 1109-1124
    • (1993) Stat Med , vol.12 , pp. 1109-1124
    • Schall, R.1    Luus, H.E.2
  • 13
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    • Individual bioequivalence - A European perspective
    • Steinijans VW, Hauschke D 1997 Individual bioequivalence - a European perspective. J Biopharm Stat 7: 31-34
    • (1997) J Biopharm Stat , vol.7 , pp. 31-34
    • Steinijans, V.W.1    Hauschke, D.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.