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Literature DB >> 21895035

Pharmacometrics for regulatory decision making: status and perspective.

Efthymios Manolis¹, Ralf Herold.

Abstract

Mesh：

Year: 2011 PMID： 21895035 DOI： 10.2165/11594340-000000000-00000

Source DB: PubMed Journal: Clin Pharmacokinet ISSN： 0312-5963 Impact factor: 6.447

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3 in total

1. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework.

Authors: Efthymios Manolis; Gérard Pons
Journal: Br J Clin Pharmacol Date: 2009-10 Impact factor: 4.335

Review 2. Role of modeling and simulation in pediatric investigation plans.

Authors: Efthymios Manolis; Tariq Eldirdiry Osman; Ralf Herold; Franz Koenig; Paolo Tomasi; Spiros Vamvakas; Agnes Saint Raymond
Journal: Paediatr Anaesth Date: 2011-01-18 Impact factor: 2.556

3. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.

Authors: Joo Yeon Lee; Christine E Garnett; Jogarao V S Gobburu; Venkatesh A Bhattaram; Satjit Brar; Justin C Earp; Pravin R Jadhav; Kevin Krudys; Lawrence J Lesko; Fang Li; Jiang Liu; Rajnikanth Madabushi; Anshu Marathe; Nitin Mehrotra; Christoffer Tornoe; Yaning Wang; Hao Zhu
Journal: Clin Pharmacokinet Date: 2011-10 Impact factor: 6.447

3 in total

8 in total

Review 1. Role of modelling and simulation: a European regulatory perspective.

Authors: Siv Jönsson; Anja Henningsson; Monica Edholm; Tomas Salmonson
Journal: Clin Pharmacokinet Date: 2012-02-01 Impact factor: 6.447

2. Evaluation of the long-term durability and glycemic control of fasting plasma glucose and glycosylated hemoglobin for pioglitazone in Japanese patients with type 2 diabetes.

Authors: Frances Stringer; Joost DeJongh; Kazuaki Enya; Emiko Koumura; Meindert Danhof; Kohei Kaku
Journal: Diabetes Technol Ther Date: 2014-12-22 Impact factor: 6.118

Review 3. Applications of pharmacometrics in the clinical development and pharmacotherapy of anti-infectives.

Authors: Ashit Trivedi; Richard E Lee; Bernd Meibohm
Journal: Expert Rev Clin Pharmacol Date: 2013-03 Impact factor: 5.045

4. Regulatory modeling and simulation moves into the next gear in europe.

Authors: P H van der Graaf
Journal: CPT Pharmacometrics Syst Pharmacol Date: 2013-02-27

5. The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.

Authors: E Manolis; S Rohou; R Hemmings; T Salmonson; M Karlsson; P A Milligan
Journal: CPT Pharmacometrics Syst Pharmacol Date: 2013-02-27