Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms-Reference-Cited by-同舟云学术

Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms

Published:2015-01-21 Issue:2 Volume:36 Page:93-103
ISSN:0142-2782
Container-title:Biopharmaceutics & Drug Disposition
language:en
Short-container-title:Biopharm. Drug Dispos.

Author:

Scheerans Christian¹,Heinig Roland¹,Mueck Wolfgang¹

Affiliation:

1. Clinical Pharmacology Bayer Pharma AG Research Center Wuppertal Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/bdd.1923

Reference44 articles.

1. EMA.(Draft XXIII) Guideline on the pharmacokinetic and clinical evaluation of modified‐release dosage forms. EMA/CHMP/EWP/280/96 Rev1. London 21 February2013.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140482.pdf[28 February 2014].

2. EUFEPS BABP Network Open Discussion Forum: Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms. 17–18 June 2013 in Bonn Germany.https://custom.cvent.com/6E33084F71EB4DD6B892656072736BFB/files/2d4231a4d943496194dd6e258bfdc843.pdf[28 February 2014].

3. EUFEPS BABP Network Open Discussion Forum: Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms. 17–18 June 2013 in Bonn Germany. Session III: Specific issues for BE assessment by Alfredo García Arieta AEMPS Madrid ES.https://custom.cvent.com/6E33084F71EB4DD6B892656072736BFB/files/07323e6d219f47cdae68e89f1f508b6b.pdf[28 February 2014].

4. Ueber die Bedingungen fuer die Akkumulation indifferenter Narkotika. Theoretische Berechnungen;Widmark EMP;Biochem Z,1924

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