Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets-Reference-Cited by-同舟云学术

Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets

Published:2018-05-22 Issue:8 Volume:84 Page:1729-1737
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

González-Rojano Esperanza¹,Abad-Santos Francisco¹,Ochoa Dolores¹,Román Manuel¹,Marcotegui Julio²,Álvarez Covadonga³,Gordon John⁴,García-Arieta Alfredo⁵^ORCID

Affiliation:

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

2. Department of Anaesthesiology, Reanimation and Pain Treatment; Hospital Clínico San Carlos; Madrid Spain

3. Pharmaceutical Technology, Facultad de Farmacia; Universidad Complutense de Madrid; Spain

4. Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences; Therapeutic Products Directorate, Health Canada; Ottawa Canada

5. Service on Pharmacokinetics and Generics, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines; Spanish Agency for Medicines and Health Care Products; Madrid Spain

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.13601/fullpdf

Reference16 articles.

1. European Medicines Agency Guideline on the investigation of bioequivalence http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

2. US Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER) Guidance for industry. Bioavailability and bioequivalence. Studies for orally administered drug products - general considerations http://www.fda.gov/ohrms/dockets/ac/03/briefing/3995B1_07_GFI-BioAvail-BioEquiv.pdf

3. Pharmacokinetic analysis of bioequivalence trials: implications for sex-related issues in clinical pharmacology and biopharmaceutics;Chen;Clin Pharmacol Ther,2000

4. Sex-by-formulation interaction assessed through a bioequivalence study of efavirenz tablets;Ibarra;Eur J Pharm Sci,2016

5. Sample size of 12 per group rule of thumb for a pilot study;Julious;Pharm Stat,2005

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4. Response to ‘Sex‐by‐formulation interaction in bioequivalence studies: the importance of formulations and experimental conditions’ by Ibarra et al.;British Journal of Clinical Pharmacology;2019-01-28

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