Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design

Author:

Vozmediano ValvaneraORCID,Sologuren Ander,Lukas John C.,Leal Nerea,Rodriguez Mónica

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference52 articles.

1. Pozas M, Rodriguez M, Valls I, Soler A, Vozmediano V. Considerations about paediatric dosing: from birth to adulthood, pharmacokinetics and pharmacodynamics. Int J Pharm [Internet]. 2014;469(2):238–9. Available from: http://www.sciencedirect.com/science/article/pii/S0378517314002853

2. Zisowsky J, Krause A, Dingemanse J. Drug development for pediatric populations: regulatory aspects. Pharmaceutics. 2010;2(4):364–88.

3. Field MJ, Behrman RE, Children I of M (US) C on CRI. Ethical conduct of clinical research involving children. [Internet]. Washington, D.C.: National Academies Press (US); 2004. Available from: http://www.ncbi.nlm.nih.gov/books/NBK25542/ . Accessed 31 Aug 2010.

4. European Medicines Agency ICH Topic E11: Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003066.pdf . Accessed 31 Aug 2010.

5. European Commission. Ethical considerations for clinical trials on medicinal products with the paediatric population (Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct. 2008. p. 1–34. Available from: http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-10/ethical_considerations_en.pdf .

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3