Individual and average bioequivalence of highly variable drugs and drug products

被引：33

作者：

Midha, KK ^{[1
]}

Rawson, MJ ^{[1
]}

Hubbard, JW ^{[1
]}

机构：

[1] Univ Saskatchewan, Coll Pharm & Nutr, Drug Metab Drug Disposit Grp, Saskatoon, SK S7N 5C9, Canada

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 1997年 / 86卷 / 11期

关键词：

D O I：

10.1021/js960516+

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

[No abstract available]

引用

页码：1193 / 1197

页数：5

共 30 条

[1] CONSIDERATION OF INDIVIDUAL BIOEQUIVALENCE [J].

ANDERSON, S ;

HAUCK, WW .

JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1990, 18 (03) :259-273

[2]

Anderson S, 1996, INT J CLIN PHARM TH, V34, P369

[3]

ANDERSON S, 1993, INDIVIDUAL BIOEQUIVA

[4]

[Anonymous], 1977, FED REG, V42, P1648

[5]

Blume H, 1995, BIOINTERNATIONAL, P117

[6] BIO-INTERNATIONAL-94, CONFERENCE ON BIOAVAILABILITY, BIOEQUIVALENCE AND PHARMACOKINETIC STUDIES - PRE-CONFERENCE SATELLITE ON IN-VIVO IN-VITRO CORRELATION - MUNICH, GERMANY, 14-17 JUNE 1994 [J].

BLUME, HH ;

MCGILVERAY, IJ ;

MIDHA, KK .

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 1995, 3 (02) :113-124

[7] BIO-INTERNATIONAL 92, CONFERENCE ON BIOAVAILABILITY, BIOEQUIVALENCE AND PHARMACOKINETIC STUDIES - BAD-HOMBURG, GERMANY, MAY 20-22, 1992 [J].

BLUME, HH ;

MIDHA, KK .

PHARMACEUTICAL RESEARCH, 1993, 10 (12) :1806-1811

[8] An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs [J].

Boddy, AW ;

Snikeris, FC ;

Kringle, RO ;

Wei, GCG ;

Oppermann, JA ;

Midha, KK .

PHARMACEUTICAL RESEARCH, 1995, 12 (12) :1865-1868

[9] ASSESSMENT OF 75/75 RULE - FDA VIEWPOINT [J].

CABANA, BE .

JOURNAL OF PHARMACEUTICAL SCIENCES, 1983, 72 (01) :98-99

[10]

ENDRENYI L, 1994, INT J CLIN PHARM TH, V32, P497

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