Step 1 of 5

Select Your NAMs Platform Type

Choose the primary technology that defines your New Approach Methodology.

🔬

Organ-on-Chip

Microphysiological systems with flow

🧫

Organoid

3D self-organizing tissue models

⚗️

Spheroid / 3D Culture

Scaffold-free 3D microtissues

💻

In Silico Model

PBPK, QSP, AI/ML computational

🖨️

Bioprinted Tissue

3D printed tissue constructs

🧪

Advanced In Vitro

Enhanced cell-based assays

Platform/Product Name (Optional)

Step 2 of 5

Drug Development Stage

At what stage of drug development will this NAMs data be applied?

🔍

Discovery

Target validation, hit-to-lead

🧬

Preclinical / IND-Enabling

Safety, toxicity, ADME

1️⃣

Phase I Support

First-in-human dose selection

2️⃣

Phase II/III Support

Patient stratification, efficacy

📋

Labeling / Post-Market

DDI, special populations

Step 3 of 5

What Question Will the NAMs Answer?

Define the specific regulatory or scientific question your NAMs data will address.

Primary Question Category

Specific Question Statement

Describe the precise question your NAMs will answer in regulatory context.

Step 4 of 5

Define Endpoints and Acceptance Criteria

Specify what you will measure and how results will be interpreted.

Primary Endpoint(s)

List the main measurements or readouts from your NAMs.

Acceptance Criteria

Define thresholds or decision rules for positive/negative findings.

Reference Standard (if applicable)

What existing test or clinical data will you benchmark against?

Step 5 of 5

Supporting Data Requirements

Select the evidence package components you will provide.

Analytical Validation

Precision, accuracy, reproducibility of assay readouts

Biological Qualification

Demonstration of relevant human biology / phenotype

Reference Compound Testing

Validation with known positive/negative compounds

Clinical Correlation Data

Comparison to human clinical outcomes where available

Reproducibility Studies

Inter-laboratory or multi-site reproducibility

SOPs and Documentation

Detailed protocols for assay execution

📄

Your Context of Use Statement

Ready for regulatory submission or ISTAND qualification

Context of Use Builder

Select Your NAMs Platform Type

Drug Development Stage

What Question Will the NAMs Answer?

Define Endpoints and Acceptance Criteria

Supporting Data Requirements

📚 CoU Templates by Application