Evidence map›Paper›PMID 30833427›Full record

ReviewAntimicrobial agents and chemotherapy2019

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

M L Rizk, S M Bhavnani, G Drusano, A Dane, A E Eakin, T Guina, S H Jang, J F Tomayko, J Wang, L Zhuang and 1 more

Abstract readReview
In one paragraph

Review in Antimicrobial agents and chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. The Evolution of Heteroresistance via Small Colony Variants inbioRxiv : the preprint server for biology · 2024
    Article
  8. Lessons Are Still Being Learned about Intrapulmonary Antibiotic Concentrations.American journal of respiratory and critical care medicine · 2024
    Article
  9. Review
  10. A Pharmacodynamic Study of Aminoglycosides against PathogenicPharmaceuticals (Basel, Switzerland) · 2023
    Article
  11. Review
  12. Article
  13. Review
  14. Optimizing tylosin dosage for co-infection ofFrontiers in pharmacology · 2023
    Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

M L RizkMerck & Co. Inc., Kenilworth, New Jersey, USA matthew_rizk@merck.com thomas.lodise@acphs.edu.
S M BhavnaniInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.
G DrusanoInstitute for Therapeutic Innovation, University of Florida, Orlando, Florida, USA.
A DaneDaneStat Consulting Limited, Macclesfield, United Kingdom.
A E EakinNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
T GuinaNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
S H JangOffice of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
J F TomaykoPfizer, Wellesley, Massachusetts, USA.
J WangOffice of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
L ZhuangOffice of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
T P LodiseAlbany College of Pharmacy and Health Sciences, Albany, New York, USA matthew_rizk@merck.com thomas.lodise@acphs.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. This and the accompanying minireview on nonclinical PK/PD summarize the workshop discussions and recommendations. It is important to consider how information like PK/PD can support the clinical effectiveness of new antibacterial drugs, as PK/PD data have become central to antibacterial drug development programs. Key clinical considerations for antibacterial dose selection and clinical PK/PD characterization discussed in this minireview include a robust assessment of PK in the patient population of interest, critical considerations for assessing drug penetration in the lung for the treatment of pneumonia, and an emphasis on special populations, including patients with renal impairment and augmented renal function, as well as on dosing in obese and pediatric patients. Successful application of such approaches is now used to provide a more informative drug development package to support the approval of new antibiotics.

Indexed as

AnimalsAnti-Bacterial AgentsHumansLungPneumoniaTreatment OutcomeAnti-Bacterial Agentsantibacterialbest practices/recommendationsclinicaldose selectiondrug developmentdrug penetrationpatient populationpharmacokinetics/pharmacodynamicstranslationworkshop

Identifiers

PMID30833427
PMCPMC6496063

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.