SCOPUS 정보 검색 플랫폼

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 27, Issue 1, 2002, Pages 11-16

Biometrical evaluation of bioequivalence trials using a bootstrap individual direct curve comparison method

(3) Zintzaras, E a Bouka, P b Kowald, A c

a INSTITUTE OF TECHNOLOGY OF AGRICULTURAL PRODUCTS (Greece)

b Hellenic Organization for Standardization (Greece)

c MAX PLANCK INSTITUTE (Germany)

Author keywords

Bioequivalence; Bootstrap; Curve comparison; Individual bioequivalence

Indexed keywords

VETERINARY DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BIOMETRY; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; EVALUATION; INTERMETHOD COMPARISON; MATHEMATICAL ANALYSIS;

AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; MODELS, THEORETICAL; THERAPEUTIC EQUIVALENCY;

EID: 0036203829 PISSN: 03787966 EISSN: None Source Type: Journal
DOI: 10.1007/BF03190400 Document Type: Article

Times cited : (6)

References (21)

1
- 0003478656
- CPMP/EWP/QWP/1401/98
- (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence

2
- 1642384295
- CVMP/III/8090/89
- (1992) Conduct of Bioequivalence Studies in Animals

3
- 0023615056
- A comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability
- (1987) J. Pharmacokinet. Biopharm. , vol.15 , pp. 657-680
- Shuirmann, D.J.¹

4
- 0033369822
- Bioequivalence studies: Biometrical concepts of alternative designs and pooled analysis
- (1999) Eur. J. of Drug Metab. and Pharmacokinet. , vol.24 , pp. 225-232
- Zintzaras, E.¹ Bouka, P.²

5
- 0034863628
- Measures of exposure versus measures of rate and extent of absorption
- (2001) Clin. Pharmacokinet. , vol.40 , pp. 565-572
- Chen, M.L.¹ Lesko, L.² Williams, R.³

6
- 0026772726
- Bioequivalence
- (1992) Pharm. Res. , vol.9 , pp. 925-928
- Rescigno, A.¹

7
- 0030772854
- Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence
- (1997) Pharm. Res. , vol.14 , pp. 1363-1369
- Marston, S.A.¹ Polli, J.E.²

8
- 0034858882
- Novel direct curve comparison metrics for bioequivalence
- (2001) Pharm. Res. , vol.18 , pp. 734-741
- Polli, J.E.¹ McLean, A.M.²

9
- 0029940802
- Absorption rate vs exposure: Which is more useful for bioequivalence testing?
- (1996) Pharm. Res. , vol.13 , pp. 453-456
- Tozer, T.N.¹ Bois, F.Y.² Hauck, W.W.³ Chen, M.L.⁴ Williams, R.L.⁵

10
- 0032752062
- IVIVC: Indices for comparing release and response profiles
- (1999) Drug Dev. Ind. Pharm. , vol.25 , pp. 1223-1225
- Langenbucher, F.¹

11
- 0031779119
- In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2
- (1998) Pharm. Res. , vol.15 , pp. 889-896
- Shah, V.P.¹ Tsong, Y.² Sathe, P.³ Liu, J.P.⁴

12
- 0003455049
- New York: Marcel Dekker
- (1992) Design and analysis of bioavailability and bioequivalence studies
- Chow, S.C.¹ Liu, J.P.²

13
- 0024988106
- Consideration of individual bioequivalence
- (1990) J. Pharmacokinet. Biopharm. , vol.18 , pp. 259-273
- Anderson, S.¹ Hauck, W.W.²

14
- 0026597801
- Types of Bioequivalence and related statistical considerations
- (1992) Int. J. Clin. Pharmacol. Ther. Toxicol. , vol.30 , pp. 181-187
- Hauck, W.W.¹ Anderson, S.²

15
- 0003922013
- (2001) Guidance for Industry: Statistical Approaches to Establishing Bioequivalence

16
- 0034764371
- Individual bioequivalence revisited
- (2001) Clin. Pharmacokinet. , vol.40 , pp. 701-706
- Chen, M.L.¹ Lesko, L.J.²

17
- 0034735563
- An individual bioequivalence criterion: Regulatory considerations
- (2000) Stat. Med. , vol.19 , pp. 2821-2842
- Chen, M.L.¹ Patnaik, R.² Hauck, W.W.³ Shuirmann, D.J.⁴ Hyslop, T.⁵ William, R.⁶

18
- 0034123537
- Subject-by-formulation interaction in bioequivalence: Conseptual and statistical issues
- (2000) Pharm. Research , vol.17 , pp. 375-380
- Hauck, W.W.¹ Hyslop, T.² Chen, M.L.³ Patnaik, R.⁴ William, R.⁵

19
- 0003991665
- London: Chapman and Hall
- (1986) An Introduction to the Bootstrap
- Efron, B.¹ Tibshirani, R.²

20
- 0034439279
- The existence of sequence effect in cross-over Bioequivalence trials
- (2000) Europ. J. Drug Metab. Pharmacokinet. , vol.25 , pp. 241-244
- Zintzaras, E.¹

21
- 0003619146
- London: Chapman and Hall
- (1995) Design and Analysis of Cross-Over Trials
- Jones, B.¹ Kenward, M.G.²

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.