Pulmonary delivery has gained increased interests over the past few decades . For conditions within the respiratory tract, targeted drug delivery directly to the site of action can achieve a high local concentration for efficacy with reduced unwanted systemic exposure and adverse effect . For systemic conditions, the unique physiology of the lung evolutionarily designed for rapid gaseous exchange presents an entry route for systemic drug delivery . Although the development of inhaled formulations has come a long way over the last few decades, many aspects of it remain to be elucidated . In particular, a reliable and well-understood method for in vitro-in vivo correlations remains to be established . With the rapid and ongoing advancement of technology, there is much potential to better utilise computational methods including different types of modelling and simulation approaches to support inhaled formulation development . This review intends to provide an introduction on some fundamental concepts in pulmonary drug delivery and inhaled formulation development followed by discussions on some challenges and opportunities in the translation of inhaled pharmaceuticals from preclinical studies to clinical development . The review concludes with some recent advancements in modelling and simulation approaches that could play an increasingly important role in contemporary formulation development of inhaled pharmaceuticals.