ReviewAntibiotics (Basel, Switzerland)2024
Translational PK/PD for the Development of Novel Antibiotics-A Drug Developer's Perspective.
Review in Antibiotics (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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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.
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Who cites it
10 citing papers in PubMed.
- ASP-COMPLEX: redefining antimicrobial stewardship to improve outcomes in high-risk patients with severe infections.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026Review
- Model-based quantification of immune response and anti-staphylococcal activity of afabicin in immunocompetent mouse thigh infections to enable predictions of clinical efficacy.Antimicrobial agents and chemotherapy · 2026Article
- Distributed Pharmacodynamic Architecture in Multi-Component Herbal Formulations: A Flux-Based Framework for Redox-Heterogeneous Diseases.Pharmaceutics · 2026Review
- Review
- Synergistic Interactions Between Natural Phenolic Compounds and Antibiotics Against Multidrug-ResistantMicroorganisms · 2025Article
- The Changing Landscape of Antibiotic Treatment: Reevaluating Treatment Length in the Age of New Agents.Antibiotics (Basel, Switzerland) · 2025Review
- A Pharmacokinetic-Pharmacodynamic Study of Protosappanoside D, a Component Derived fromInternational journal of molecular sciences · 2025Article
- Enhancing antibiotic therapy through comprehensive pharmacokinetic/pharmacodynamic principles.Frontiers in cellular and infection microbiology · 2025Review
- Electrochemical Sensors for Antibiotic Detection: A Focused Review with a Brief Overview of Commercial Technologies.Sensors (Basel, Switzerland) · 2024Review
- Revisiting the Checkerboard to Inform Development of β-Lactam/β-Lactamase Inhibitor Combinations.Antibiotics (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Antibiotic development traditionally involved large Phase 3 programs, preceded by Phase 2 studies. Recognizing the high unmet medical need for new antibiotics and, in some cases, challenges to conducting large clinical trials, regulators created a streamlined clinical development pathway in which a lean clinical efficacy dataset is complemented by nonclinical data as supportive evidence of efficacy. In this context, translational Pharmacokinetic/Pharmacodynamic (PK/PD) plays a key role and is a major contributor to a "robust" nonclinical package. The classical PK/PD index approach, proven successful for established classes of antibiotics, is at the core of recent antibiotic approvals and the current antibacterial PK/PD guidelines by regulators. Nevertheless, in the case of novel antibiotics with a novel Mechanism of Action (MoA), there is no prior experience with the PK/PD index approach as the basis for translating nonclinical efficacy to clinical outcome, and additional nonclinical studies and PK/PD analyses might be considered to increase confidence. In this review, we discuss the value and limitations of the classical PK/PD approach and present potential risk mitigation activities, including the introduction of a semi-mechanism-based PK/PD modeling approach. We propose a general nonclinical PK/PD package from which drug developers might choose the studies most relevant for each individual candidate in order to build up a "robust" nonclinical PK/PD understanding.
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Registered trials
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.