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Literature DB >> 1438007

Bioequivalence.

Abstract

The bioequivalence of two formulations of the same drug may be determined by evaluating the similarity of their respective plasma concentration curves. The similarity of two plasma concentration functions can be measured by an index called the bioequivalence index. This paper shows how such an index may be defined and calculated.

Mesh：

Year: 1992 PMID： 1438007 DOI： 10.1023/a:1015809201503

Source DB: PubMed Journal: Pharm Res ISSN： 0724-8741 Impact factor: 4.200

1 in total

1. Bioavailability--a problem in equivalence.

Authors: C M Metzler
Journal: Biometrics Date: 1974-06 Impact factor: 2.571

1 in total

14 in total

1. Novel direct curve comparison metrics for bioequivalence.

Authors: J E Polli; A M McLean
Journal: Pharm Res Date: 2001-06 Impact factor: 4.200

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

Authors: E Zintzaras; P Bouka; A Kowald
Journal: Eur J Drug Metab Pharmacokinet Date: 2002 Jan-Mar Impact factor: 2.441

3. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles.

Authors: Yong Zhang; Meirong Huo; Jianping Zhou; Aifeng Zou; Weize Li; Chengli Yao; Shaofei Xie
Journal: AAPS J Date: 2010-04-06 Impact factor: 4.009

4. Statistical aspects of bioequivalence testing between two medicinal products.

Authors: E Zintzaras
Journal: Eur J Drug Metab Pharmacokinet Date: 2005 Jan-Jun Impact factor: 2.441

5. When is a metric not a metric? Remarks on direct curve comparison in bioequivalence studies.

Authors: Wojciech Jawień
Journal: J Pharmacokinet Pharmacodyn Date: 2009-06-21 Impact factor: 2.745

6. Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence.

Authors: S A Marston; J E Polli
Journal: Pharm Res Date: 1997-10 Impact factor: 4.200

Bioequivalence.

1. Bioavailability--a problem in equivalence.

1. Novel direct curve comparison metrics for bioequivalence.

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

3. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles.

4. Statistical aspects of bioequivalence testing between two medicinal products.

5. When is a metric not a metric? Remarks on direct curve comparison in bioequivalence studies.

6. Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence.

7. In-vitro dissolution profile comparison: statistics and analysis, model dependent approach.

8. Modeling in frequency domain used for assessment of in vivo dissolution profile.

Review 9. Pharmacokinetics of endogenous substances: some problems and some solutions.

10. Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.