Deterministic chaos and wash-out determination in crossover trials-Reference-Cited by-同舟云学术

Deterministic chaos and wash-out determination in crossover trials

Published:2016-10 Issue:1 Volume:1 Page:43-53
ISSN:2053-0846
Container-title:International Journal of Pharmacokinetics
language:en
Short-container-title:International Journal of Pharmacokinetics

Author:

Grabowski Tomasz¹,Cox Gad Shayne²,Jaroszewski Jerzy J³,Guelen Pieter JM⁴

Affiliation:

1. Polpharma Biologics, Trzy lipy 3, 80–172 Gdańsk, Poland

2. Gad Consulting Services, 102 Woodtrail Lane, Cary, NC 27518, USA

3. Department of Pharmacology & Toxicology, Faculty of Veterinary Medicine, University of Warmia & Mazury in Olsztyn, Oczapowskiego 13, 10–718 Olsztyn, Poland

4. Pharmacokinetic Consultancy Services, Voorstraat 11, 5371 KE Dieden, The Netherlands

Abstract

Background: Key elements of crossover studies are the determination of the wash-out (clearance) period. The purpose of this work is an attempt to implement and justify the use of deterministic chaos theory for estimating the wash-out value and reference the obtained values to the currently applicable rules. Results/methodology: The elliptical model of drug wash-out was presented to prove the hypothesis. Pharmacokinetic profiles were used for the analysis, obtained from healthy subjects during 12 studies. Conclusion: On the grounds of these calculations it may be concluded that the pharmacokinetics of xenobiotics, such as drugs, is a product of deterministic chaos.

Publisher

Future Science Ltd

Link

http://www.future-science.com/doi/pdf/10.4155/ipk.16.1

Reference42 articles.

1. HC. Draft Guidance Document: Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma. 1–16 (2011).

2. US FDA. Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. 1–18 (2014).

3. ICH. Statistical principles for clinical trials E9. 1–39 (1998).

4. US FDA. Guideline for industry structure and content of clinical study reports. 1–55 (1996).

5. EMA. Guideline on statistical principles for veterinary clinical trials. EMEA/CVMP/816/00-Final. 1–25 (2000).

Cited by 3 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. How long does a single oral dose of cannabidiol persist in plasma? Findings from three clinical trials;Drug Testing and Analysis;2022-12-19

2. Impact of fan therapy during exercise on breathlessness and recovery time in patients with COPD: a pilot randomised controlled crossover trial;ERJ Open Research;2021-09-02

3. Welcome to the International Journal of Pharmacokinetics;International Journal of Pharmacokinetics;2016-10