Literature DB >> 22089340

Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond.

J W Mandema1, M Gibbs, R A Boyd, D R Wada, M Pfister.   

Abstract

High development cost, low development success, cost-disciplined health-care policies, and intense competition demand an efficient drug development process. New compounds need to bring value to patients by being safe, efficacious, and cost-effective as compared with existing treatment options. Model-based meta-analysis (MBMA) facilitates integration and utilization of summary-level efficacy and safety data, providing a quantitative framework for comparative efficacy and safety assessment. This Commentary discusses the application and limitations of MBMA in drug development.

Entities:  

Mesh:

Substances:

Year:  2011        PMID: 22089340     DOI: 10.1038/clpt.2011.242

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  31 in total

1.  Efficacy of DPP-4 inhibitors, GLP-1 analogues, and SGLT2 inhibitors as add-ons to metformin monotherapy in T2DM patients: a model-based meta-analysis.

Authors:  Hiroyuki Inoue; Yoko Tamaki; Yushi Kashihara; Shota Muraki; Makoto Kakara; Takeshi Hirota; Ichiro Ieiri
Journal:  Br J Clin Pharmacol       Date:  2018-12-06       Impact factor: 4.335

Review 2.  Clinical pharmacology considerations in biologics development.

Authors:  Liang Zhao; Tian-hua Ren; Diane D Wang
Journal:  Acta Pharmacol Sin       Date:  2012-09-24       Impact factor: 6.150

3.  Longitudinal model-based meta-analysis for survival probabilities in patients with castration-resistant prostate cancer.

Authors:  Wenjun Chen; Liang Li; Shuangmin Ji; Xuyang Song; Wei Lu; Tianyan Zhou
Journal:  Eur J Clin Pharmacol       Date:  2020-01-10       Impact factor: 2.953

4.  Population pharmacokinetics analysis of olanzapine for Chinese psychotic patients based on clinical therapeutic drug monitoring data with assistance of meta-analysis.

Authors:  Anyue Yin; Dewei Shang; Yuguan Wen; Liang Li; Tianyan Zhou; Wei Lu
Journal:  Eur J Clin Pharmacol       Date:  2016-04-27       Impact factor: 2.953

5.  Disease Progression Modeling: Key Concepts and Recent Developments.

Authors:  Sarah F Cook; Robert R Bies
Journal:  Curr Pharmacol Rep       Date:  2016-08-15

6.  Rheumatoid arthritis: Threshold for success in RA drug development.

Authors:  Stanley B Cohen
Journal:  Nat Rev Rheumatol       Date:  2012-09-11       Impact factor: 20.543

7.  Toward a robust tool for pharmacokinetic-based personalization of treatment with tacrolimus in solid organ transplantation: A model-based meta-analysis approach.

Authors:  Tom M Nanga; Thao T P Doan; Pierre Marquet; Flora T Musuamba
Journal:  Br J Clin Pharmacol       Date:  2019-12-17       Impact factor: 4.335

8.  Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.

Authors:  S F Marshall; R Burghaus; V Cosson; S Y A Cheung; M Chenel; O DellaPasqua; N Frey; B Hamrén; L Harnisch; F Ivanow; T Kerbusch; J Lippert; P A Milligan; S Rohou; A Staab; J L Steimer; C Tornøe; S A G Visser
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2016-03-14

9.  Model-Based Meta-Analysis in Psoriasis: A Quantitative Comparison of Biologics and Small Targeted Molecules.

Authors:  Huan He; Wenwen Wu; Yi Zhang; Meng Zhang; Ning Sun; Libo Zhao; Xiaoling Wang
Journal:  Front Pharmacol       Date:  2021-07-01       Impact factor: 5.810

10.  A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment of type 2 diabetes mellitus.

Authors:  Jorge Luiz Gross; James Rogers; Daniel Polhamus; William Gillespie; Christian Friedrich; Yan Gong; Brigitta Ursula Monz; Sanjay Patel; Alexander Staab; Silke Retlich
Journal:  BMJ Open       Date:  2013-03-05       Impact factor: 2.692

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.