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Volumn 33, Issue 2, 1999, Pages 435-444

Individual bioequivalence - A review of the FDA draft guidance

Author keywords

Brand name drugs; Food and Drug Administration; Generic drugs; Individual bioequivalence

Indexed keywords

BIOEQUIVALENCE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; IN VIVO STUDY; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; REVIEW;

EID: 0033038778     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159903300215     Document Type: Review
Times cited : (33)

References (18)
  • 3
    • 0024988106 scopus 로고
    • Consideration of individual bioequivalence
    • Anderson S, Hauck WW. Consideration of individual bioequivalence. J Pharmacokin Biopharma. 1990;18:259-273.
    • (1990) J Pharmacokin Biopharma , vol.18 , pp. 259-273
    • Anderson, S.1    Hauck, W.W.2
  • 4
    • 0345137752 scopus 로고    scopus 로고
    • Rockville, MD: Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration
    • FDA. Draft Guidance on In Vivo Bioequivalence Studies on Population and Individual Bioequivalence. Rockville, MD: Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration; 1997.
    • (1997) Draft Guidance on in Vivo Bioequivalence Studies on Population and Individual Bioequivalence
  • 5
    • 0030949859 scopus 로고    scopus 로고
    • Individual bioequivalence - A regulatory update
    • Chen ML. Individual bioequivalence - a regulatory update. J Biopharma Stat. 1997;7:5-11.
    • (1997) J Biopharma Stat , vol.7 , pp. 5-11
    • Chen, M.L.1
  • 6
    • 0030907413 scopus 로고    scopus 로고
    • Meta-analysis for bioequivalence review
    • Chow SC, Liu JP. Meta-analysis for bioequivalence review. J Biopharma Stat. 1997;7:97-111.
    • (1997) J Biopharma Stat , vol.7 , pp. 97-111
    • Chow, S.C.1    Liu, J.P.2
  • 7
    • 84950182824 scopus 로고
    • On the assessment of variability in bioavailability/bioequivalence studies
    • Liu JP, Chow SC. On the assessment of variability in bioavailability/bioequivalence studies. Comm Stat Theory Methods. 1992;21:2591-2608.
    • (1992) Comm Stat Theory Methods , vol.21 , pp. 2591-2608
    • Liu, J.P.1    Chow, S.C.2
  • 8
    • 0030959424 scopus 로고    scopus 로고
    • Some thoughts on individual bioequivalence
    • Liu JP, Chow SC. Some thoughts on individual bioequivalence. J Biopharma Stat. 1997;7(1):41-48.
    • (1997) J Biopharma Stat , vol.7 , Issue.1 , pp. 41-48
    • Liu, J.P.1    Chow, S.C.2
  • 9
    • 0028291201 scopus 로고
    • Extension to the use of tolerance intervals for assessment of individual bioequivalence
    • Esinhart JD, Chinchilli VM. Extension to the use of tolerance intervals for assessment of individual bioequivalence. J Biopharma Stat. 1994;4:39-52.
    • (1994) J Biopharma Stat , vol.4 , pp. 39-52
    • Esinhart, J.D.1    Chinchilli, V.M.2
  • 10
    • 0026481178 scopus 로고
    • Bioequivalence revisited
    • Sheiner LB. Bioequivalence revisited. Stat Med. 1992;11:1777-1788.
    • (1992) Stat Med , vol.11 , pp. 1777-1788
    • Sheiner, L.B.1
  • 11
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • Schall R, Luus RE. On population and individual bioequivalence. Stat Med. 1993;12:1109-1124.
    • (1993) Stat Med , vol.12 , pp. 1109-1124
    • Schall, R.1    Luus, R.E.2
  • 12
    • 0001474373 scopus 로고
    • Moment-based criteria for determining bioequivalence
    • Holder DJ, Hsuan F. Moment-based criteria for determining bioequivalence. Biometrika. 1993;80: 835-846.
    • (1993) Biometrika , vol.80 , pp. 835-846
    • Holder, D.J.1    Hsuan, F.2
  • 13
    • 0025359983 scopus 로고
    • Outliers detection in bioavailability/bioequivalence
    • Chow SC, Tse SK. Outliers detection in bioavailability/bioequivalence. Stat Med. 1990;9:549-558.
    • (1990) Stat Med , vol.9 , pp. 549-558
    • Chow, S.C.1    Tse, S.K.2
  • 14
    • 0025879176 scopus 로고
    • Detection of outlying data in bioavailability/bioequivalence studies
    • Liu JP, Weng CS. Detection of outlying data in bioavailability/bioequivalence studies. Stat Med. 1992; 10:1375-1389.
    • (1992) Stat Med , vol.10 , pp. 1375-1389
    • Liu, J.P.1    Weng, C.S.2
  • 15
    • 84993695201 scopus 로고
    • Special issue on bioavailability and bioequivalence
    • Chow SC, ed. Special issue on bioavailability and bioequivalence. Drug Inf J. 1995;29(3).
    • (1995) Drug Inf J , vol.29 , Issue.3
    • Chow, S.C.1
  • 16
    • 0344275251 scopus 로고    scopus 로고
    • Special issue on bioavailability and bioequivalence
    • Chow SC, ed. Special issue on bioavailability and bioequivalence. J Biopharma Stat. 1997;7(1).
    • (1997) J Biopharma Stat , vol.7 , Issue.1
    • Chow, S.C.1
  • 17
    • 0345569296 scopus 로고    scopus 로고
    • Special issue on individual bioequivalence
    • Chow SC, Liu JP, eds. Special issue on individual bioequivalence. Stat Med. 1999.
    • (1999) Stat Med
    • Chow, S.C.1    Liu, J.P.2
  • 18
    • 0029151903 scopus 로고
    • Current issues in bioequivalence trials
    • Chow SC. Current issues in bioequivalence trials. Drug Inf J. 1995;29(3):795-804.
    • (1995) Drug Inf J , vol.29 , Issue.3 , pp. 795-804
    • Chow, S.C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.