Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents-Reference-Cited by-同舟云学术

Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents

Published:2019-05 Issue:5 Volume:63 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Rizk M. L.¹,Bhavnani S. M.²,Drusano G.³,Dane A.⁴,Eakin A. E.⁵,Guina T.⁵,Jang S. H.⁶,Tomayko J. F.⁷,Wang J.⁶,Zhuang L.⁶,Lodise T. P.⁸

Affiliation:

1. Merck & Co. Inc., Kenilworth, New Jersey, USA

2. Institute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA

3. Institute for Therapeutic Innovation, University of Florida, Orlando, Florida, USA

4. DaneStat Consulting Limited, Macclesfield, United Kingdom

5. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA

6. Office of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

7. Pfizer, Wellesley, Massachusetts, USA

8. Albany College of Pharmacy and Health Sciences, Albany, New York, USA

Abstract

In June 2017, The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, organized a workshop entitled “Pharmacokinetics-Pharmacodynamics (PK/PD) for Development of Therapeutics against Bacterial Pathogens” to discuss details and critical parameters of various PK/PD methods and identify approaches for linking human pharmacokinetic (PK) data and drug efficacy analyses. The workshop participants included individuals from academia, industry, and government.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/AAC.02309-18

Reference45 articles.

1. White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs

2. FDA. 2017. Guidance for industry antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases. FDA, Silver Spring, MD.

3. EMA. 2014. Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. EMA/CHMP/351889/2013. European Medicines Agency, London, United Kingdom.

4. EMA. 2017. Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products. EMA/CHMP/594085/2015. European Medicines Agency, London, United Kingdom.

5. Generating Robust and Informative Nonclinical In Vitro and In Vivo Bacterial Infection Model Efficacy Data To Support Translation to Humans

Cited by 46 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The evolution of heteroresistance via small colony variants in Escherichia coli following long term exposure to bacteriostatic antibiotics;Nature Communications;2024-09-11

2. Risk Factors Associated with Antibiotic Exposure Variability in Critically Ill Patients: A Systematic Review;Antibiotics;2024-08-24

3. Lessons Are Still Being Learned about Intrapulmonary Antibiotic Concentrations;American Journal of Respiratory and Critical Care Medicine;2024-04-01

4. Translational PK/PD for the Development of Novel Antibiotics—A Drug Developer’s Perspective;Antibiotics;2024-01-11

5. A Pharmacodynamic Study of Aminoglycosides against Pathogenic E. coli through Monte Carlo Simulation;Pharmaceuticals;2023-12-24