Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antibacterial Agents: A Review

Author:

Jorda Anselm,Zeitlinger Markus

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference72 articles.

1. World Health Organization. Global antimicrobial resistance surveillance system (GLASS) report: early implementation 2016–2017. Geneva: World Health Organization; 2017.

2. Global Health Metrics. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1151–210.

3. Woods K, Wathion N. European Medicines Agency: 20th anniversary book. London: Core Media Services UK Ltd.; 2015.

4. EMA. Authorisation of medicines. Available from: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines. Accessed 8 Nov 2019.

5. EMA-CHMP. Guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections: revision 3 (EMA/844951/2018). London: European Medicines Agency; 2018.

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