fbpx

IND Enabling Studies

IND enabling studies include a list of assays recommended by the United States F.D.A. to apply for the status of an Investigational New Drug (IND). Once the status of Investigational New Drug is secured, companies can proceed to clinical trials, making an approved IND one of the most important steps in drug development.

IND Enabling Studies Overview

The goal of the IND application section on pharmacology and toxicology (PT) is to show with safety and pharmacokinetic data, that the drug candidate is safe for clinical trials. According to the F.D.A., these studies may be done in vivo or in vitro. Because of the advances in in vitro assays over the past 20 years, along with the time and cost savings seen when running in vitro studies, more companies are successfully submitting IND applications with in vitro data than ever before.

How IONTOX Supports Companies Applying For the IND

IONTOX supports companies applying for the IND with a combination of in vitro assays and data interpretation. In addition to providing a detailed final report for each study, IONTOX will suggest follow-up studies to improve the likelihood of F.D.A. acceptance when necessary.

IND Enabling Assays

IONTOX Recommended Assays For The IND (Based On F.D.A. Guidelines)
Caco-2 Permeability Unidirectional - Caco-2 Cells
•2 concentrations, 3 replicants, 1 time point
•LC/MS/MS endpoint
Caco-2 Permeability Bidirectional - Caco-2 Cells
•2 concentrations, 3 replicants, 1 time point
•LC/MS/MS endpoint
CYP Induction - Hepatocytes
•4 concentrations, 4 target CYPs, 1 time point
•mRNA expression or enzyme activity/cytotoxicity endpoint
CYP Inhibition - Microsomes/Supersomes
•3 concentrations, 4 target CYPs, 4 time points
•LC/MS/MS or fluorescence endpoint
Metabolic Stability - Microsomes/Blood/Hepatocyte Model depends on molecule type
•2 concentrations, 3 replicants, 2 time points
•Disappearance of parent over time LC/MS/MS endpoint
Metabolite ID - Specialized Bioanalytical dependent on metabolite
•2 concentrations, 3 replicants, 6 time points
•Typically LC/MS/MS combined with a secondary method endpoint
Plasma Protein Binding - Human Plasma/Equilibrium Dialysis
•2 concentrations, 3 replicants, 4 time points
•LC/MS/MS endpoint
Reaction Phenotyping - Determines which CYP enzymes contribute to metabolism: Microsomes
•2 concentrations, 3 replicants, 2 time points
•LC/MS/MS endpoint
Blood Partitioning - Human Plasma/Equilibrium Dialysis
•2 concentrations, 3 replicants, 4 time points
•LC/MS/MS endpoint
Transporter Interactions - Transfected Cell Models
•13 transporters, 2 concentrations, 3 replicants, 1 time point
•LC/MS/MS endpoint
Cytotoxicity - (ATP, LDH, or MTT) specialized assays available on request
•1 species, 6 concentrations, 3 replicants, 1 time point
•Endpoint depends on assay
Hemolysis - Fresh RBCs, Hemoglobin Release
•1 species, 6 concentrations, 3 replicants, 1 time point
•Hemoglobin spectrometry

Contact IONTOX About Running Your IND Enabling Studies

Click the button below and fill out the form on the following page to contact IONTOX about IND enabling studies