Utility of Pilot Studies for Predicting Ratios and Intrasubject Variability in High-Variability Drugs-Reference-Cited by-同舟云学术

Utility of Pilot Studies for Predicting Ratios and Intrasubject Variability in High-Variability Drugs

Published:2016-02-09 Issue:2 Volume:119 Page:215-221
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; La Princesa University Hospital; Teófilo Hernando Institute; Autonomous University of Madrid (UAM); Princesa Health Research Institute (IP); Madrid Spain

2. Networking Biomedical Research Centre in Hepatic and Digestive Diseases (CIBERehd); Carlos III Health Institute; 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.12558/fullpdf

Reference23 articles.

1. Pilot trial for the assessment of relative bioavailability in generic drug product development: statistical power;Wang;J Biopharm Stat,1999

2. What is a pilot or feasibility study? A review of current practice and editorial policy;Arain;BMC Med Res Methodol,2010

3. The design and interpretation of pilot trials in clinical research in critical care;Arnold;Crit Care Med,2009

4. Design and analysis of pilot studies: recommendations for good practice;Lancaster;J Eval Clin Pract,2004

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method;Pharmaceutics;2023-10-20

2. Development and pharmacokinetic evaluation of Neusilin® US2-based S-SNEDDS tablets for bosentan: Fasted and fed states bioavailability, IVIS® real-time biodistribution, and ex-vivo imaging;International Journal of Pharmaceutics;2023-08

3. Alternative Analysis Approaches for the Assessment of Pilot Bioavailability/Bioequivalence Studies;Pharmaceutics;2023-05-07

4. Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products;The AAPS Journal;2020-08-23