IND Filing
Package
Studies mentioned here are aligned with clinical route of administration, dose schedules and duration of treatment. Design to identify: PK/ PD responses, target organs, dose response, exposure multiples and safety margins.
A typical IND-enabling ADME package contains data from the following studies:
- Bioanalytical method development and validation in one rodent and one or more non-rodent species
- Single and multiple-doses pharmacokinetics, dose proportionality and absolute bioavailability in one rodent and one or more non-rodent species
- Plasma protein binding tests in one rodent, one or more non-rodent species and in human
- In vitro metabolism in animal and human hepatic preparations
- In vitro CYP inhibition in human liver microsomes
Some other studies include
- Mass balance and routes of excretion in rodents, including biliary excretion in rats
- Metabolite profiling and identification in rodents and non-rodents
- Transporters (T7) assays - inhibitors and substrate studies
Whitepaper
A Novel Cell-based Screening Assay for Cholesterol Biosynthetic Pathway Inhibition Using the RapidFire HTMS Platform
Download the Whitepaper