Partial Area Under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments-Reference-Cited by-同舟云学术

Partial Area Under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments

Published:2014 Issue: Volume: Page:165-190
ISSN:2210-7371
Container-title:FDA Bioequivalence Standards
language:
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Author:

Zhu Hao,Uppoor Ramana S.,Mehta Mehul,Yu Lawrence X.

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-1-4939-1252-0_7

Reference51 articles.

1. Banerjee SK, Jagannath C, Hunter RL, Dasgupta A (2000) Bioavailability of tobramycin after oral delivery in FVB mice using CRL-1605 copolymer, an inhibitor of P-glycoprotein. Life Sci 67(16):2011–2016

2. Bylund J, Bueters T (2013) Presystemic metabolism of AZ’0908, a novel mPGES-1 inhibitor: an in vitro and in vivo cross-species comparison. J Pharm Sci 102(3):1106–1115

3. 21CFR320.1 Bioavailability and bioequivalence requirements [Online]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.1 . Accessed 8 Dec 2013

4. Chen ML (1992) An alternative approach for assessment of rate of absorption in bioequivalence studies. Pharm Res 9(11):1380–1385

5. Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L (2010a) Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: workshop summary report. Clin Ther 32(10):1704–1712

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