IND Filing

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



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A Novel Cell-based Screening Assay for Cholesterol Biosynthetic Pathway Inhibition Using the RapidFire HTMS Platform

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Pharmacokinetic Strategies in CNS Drug Discovery

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