Nonclinical safety evaluation of excipients for inhalation drug products
Viktoria McDonald BSc (Hons), ERT, MRSB
AlbaTox Consulting Ltd.
Drug product development requires qualification of both the drug substance and all ingredients contained within the formulation including data on the local tolerance and systemic toxicity. Whilst many excipients are precedented as safe inactive ingredients for the inhaled route, use of a novel excipients necessitates the generation of safety data, which may be obtained from public domain or proprietary literature or by additional nonclinical (toxicology) testing. This presentation will discuss the nonclinical regulatory requirements and approaches for establishing safety data to qualify novel excipients for inhaled formulations.