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The Association of Inhalation Toxicologists (AIT) delivered a workshop at the Drug Delivery to the Lungs Conference (DDL2023) in Edinburgh on December 7, 2023. The aim was to educate academic and industry inhalation scientists involved in developing new inhaled drug molecules and formulations about inhalation toxicology. 38 April 2024 Inhalation BACK PAGE e Association of Inhalation Tox- icologists (AIT) delivered a work- shop at the Drug Delivery to the Lungs Conference (DDL2023) in Edinburgh on December 7, 2023. e aim was to educate academic and industry inhalation scientists involved in develop- ing new inhaled drug molecules and formulations about inhala- tion toxicology. Regulatory safety requirements provide a common challenge for all inhaled medi- cine developers and the meeting brought together 140 members of the scientific community to learn about the methods used for in vitro toxicity screening, in vivo study designs, toxicological end- points and regulatory toxicology. e workshop also covered tech- nical aspects of the generation, characterization and dosimetry of aerosols in toxicology studies. Inhaled medicines development Carsten Ehrhardt (Trinity College Dublin) reminded the audience that inhalation has been used as a means of drug administration for centuries. ere are many advan- tages of drug delivery to the lungs including bypassing first pass metabolism, rapid therapeutic effects, local targeting for respi- ratory disease indications and, of course, reduction of systemic side effects. However, inhaled medi- cines development is not without challenges: it is technically diffi- cult, can be more expensive than other routes of administration, requires complex device and for- mulation choices, is associated with poor patient compliance and has a high bar for commercializa- tion-reimbursement. Despite these challenges, there has been a recent upsurge of interest in inhaled drug development for traditional respi- ratory disease targets and newer ones, such as interstitial lung dis- ease and cancer (this includes the local delivery of inhaled biologics and vaccines), as well as a growing pipeline of inhaled drug candi- dates for systemic indications. In vitro inhalation toxicology Victoria Hutter (ImmuOne and the University of Hertfordshire) provided an overview of in vitro toxicology that covered the cell models available. ese range from models based on single-cell types (including primary cell cultures and cell lines) to complex organo- typic models that more faithfully represent the complexity of the respiratory tract. ese models can be cultured under liquid sub- merged or air interface conditions. e importance of choosing the right model, selecting appropriate endpoints and designing experi- The Association of Inhalation Toxicologists Workshop at DDL2023: Preclinical Medicines Development—Back to Basics Ben Forbes a , Jo Kilgour b and Simon Moore c On behalf of the Association of Inhalation Toxicologists a King's College London, Institute of Pharmaceutical Science, London, UK b Regulatory Science Associates, Mereside Toxicology Consulting and Apconix, UK c Labcorp Early Development Laboratories Limited, Huntingdon, Cambridgeshire, UK The AIT 2024 Annual Conference, "Inhalation Toxicology Rocks," will take place during the week of September 16 in Cleveland, Ohio, US, home of the Rock and Roll Hall of Fame.