Effect of Truncating AUC at 12, 24 and 48 hr When Evaluating the Bioequivalence of Drugs with a Long Half-Life-Reference-Cited by-同舟云学术

Effect of Truncating AUC at 12, 24 and 48 hr When Evaluating the Bioequivalence of Drugs with a Long Half-Life

Published:2015-07-14 Issue:1 Volume:118 Page:53-57
ISSN:1742-7835
Container-title:Basic & Clinical Pharmacology & Toxicology
language:en
Short-container-title:Basic Clin Pharmacol Toxicol

Author:

Moreno Isabel¹,Ochoa Dolores¹,Román Manuel¹,Cabaleiro Teresa¹²,Abad-Santos Francisco¹²

Affiliation:

1. Clinical Pharmacology Service; Hospital Universitario de la Princesa; Instituto Teófilo Hernando; University Autónoma de Madrid (UAM); Instituto de Investigación Sanitaria Princesa (IP); Madrid Spain

2. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd); Instituto de Salud Carlos III; Madrid Spain

Funder

Fundación Teófilo Hernando and Foundation for Biomedical Research at Hospital Universitario de La Princesa

Publisher

Wiley

Subject

Pharmacology,Toxicology,General Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcpt.12432/fullpdf

Reference18 articles.

1. CHMP Guideline on the Investigation of Bioequivalence European Medicines Agency (EMA) London 2010

2. The new European Medicines Agency guideline on the investigation of bioequivalence;Morais;Basic Clin Pharmacol Toxicol,2010

3. Evaluation of performance of the Truncated Area Under Curve (AUC) as a primary pharmacokinetic parameter in bioequivalence studies;Khandave;J Bioequiv Availab,2010

4. The Declaration of Helsinki 1964

5. CHMP Guideline for Good Clinical Practice 2002

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