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Therapeutics Resources Directory

A curated directory of resources including links to webinars, guidance documents, databases and additional tools - explore key themes from discovery through to regulatory approval.

Disclaimer: External links are provided for information only. PACE is not responsible for the content, accuracy or availability of third-party websites, and inclusion in this directory does not imply endorsement.

Themes

Select a theme to explore curated resources across the antimicrobial R&D pipeline.



Antimicrobial R&D Foundations

Fundamentals of antibacterial discovery — targets, resistance, hit-to-lead and lead optimisation.

5 resources

Value Proposition & Clinical Positioning

Target Product Profiles, clinical positioning and prioritising unmet needs.



ADME

Absorption, Distribution, Metabolism and Excretion — in vitro and in vivo profiling.



Toxicology & Safety Assessment

Cytotoxicity, safety pharmacology, NOAEL and GLP-| compliant toxicology.



In Vivo Models & Study Design

Infection models, ethics, translational relevance and statistical power.



Pharmacokinetics & Pharmacodynamics (PKPD)

MIC, PK/PD indices, dose selection and target attainment.



Clinical Development & Trial Planning

Trial designs, endpoints, comparator selection and breakpoint setting.



Regulatory Strategy & Planning

FDA /EMA / MHRA pathways, pre-IND, QIDP and scientific advice.



Formulation & CMC

Chemistry, Manufacturing and Controls, formulation, GMP and scale-up.



Supporting Resources & Networks

Funding, partnering, community networks and PPlE.



Public and Patient Involvement and Engagement (PPIE)

Guidance on involving people with lived experience of AMA throughout the research process, from planning to decision-making.