We are currently in the process of writing an IND for a PII protocol. The API is going to be mixed with water directly at the clinical with a drop of flavour to mask the taste.

Whilst Regulatory believe even how brief the Drug Product Sections of the IND will be, the documentation is still required, alongside placebo section and Drug Substance. However many believe only the Drug substance is sufficiently, whilst not much guidance on INDs I do not believe this is correct becuase we have data to support the API in water for a number of days to support the shelf life of the mixture prior to dosing if need to be stored within 48hours.

Any comments or experiences on this would be grateful.