---
title: IND-enabling studies plan for a small molecule in NASH
description: A biotech developing a novel drug for NASH asked Alacrita to create a project plan outlining costs and timelines for preclinical IND-enabling studies.
---

[Case Studies Archive - Alacrita ](https://www.alacrita.com/case-studies)

# [IND-enabling studies plan for a small molecule in NASH](https://www.alacrita.com/case-studies/nash-preclinical-due-diligence-and-project-plan)

 Written by [Cort](https://www.alacrita.com/case-studies/author/cort) | Aug 19, 2019 6:17:40 PM

## Challenge:

A biotech developing a novel drug for NASH asked Alacrita to create a project plan outlining costs and timelines for preclinical IND-enabling studies.

## Solution:

We recommended the best animal models, such as DIAMOND and STAM, of NASH for evaluating the activity of the novel drug. We also identified the most suitable IND-enabling studies for this indication, specifically focusing on preclinical studies in module 2 of the IND which includes pharmacology (in vitro and in vivo pharmacodynamic test), ADME, toxicology, and pharmacokinetics. We also estimated the time and the cost for these preclinical studies.

[View full post](https://www.alacrita.com/case-studies/nash-preclinical-due-diligence-and-project-plan)

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