Managing Drug Substances

Overview

The Drug Substances feature in Prognosis helps you forecast upstream material requirements. By defining the relationship between drug substances, drug products, and clinical trials, you can calculate the total quantity of active ingredients needed to support your trial portfolio.

Key Concepts

Drug Substance

The active pharmaceutical ingredient (API) or raw material that goes into your drug products. This is the upstream material you need to procure or manufacture.

Examples:

• Active compound (e.g., "ABC-123 API")
• Excipients or critical raw materials
• Reference standards

Drug Product

The finished dosage form that contains the drug substance. This is what gets packaged into kits and dispensed to patients.

Examples:

• Tablets (e.g., "ABC-123 100mg Tablet")
• Capsules
• Injectables
• Solutions

Relationship Chain

Drug Substance → Drug Product → Kit → Treatment Arm → Clinical Trial

Prognosis traces this relationship chain to calculate how much drug substance is needed based on patient demand in your trials.

Adding a Drug Substance

Navigate to Drug Substances

1. Click Drug Substances in the sidebar
2. Click Add Drug Substance

Configure Properties

Save Your Work

Click Save to create the drug substance. You can now link it to drug products.

Adding Drug Products

Drug products link drug substances to clinical trial kits.

Navigate to Drug Products

1. From the Drug Substances page, click on a substance
2. Click Add Drug Product or click an existing product to edit

Configure Properties

Link to Trials

Associate the drug product with clinical trials:

1. In the Associated Trials section, click Add Trial
2. Select the trial(s) that use this drug product
3. Map the drug product to the appropriate kit(s) in each trial

Understanding the Calculation

Prognosis calculates drug substance requirements by tracing demand from patients back to raw materials.

The Calculation Flow

1. Patient Demand — How many patients, how many visits, how many kits per visit?
2. Kit Consumption — How many kits of each type are needed?
3. Drug Product Need — How much drug product is in each kit?
4. Substance Requirement — How much substance is in each drug product?
5. Yield Adjustment — Account for manufacturing losses

Example Calculation

Consider a simple trial:

• 100 patients
• 10 visits per patient, 1 kit per visit
• Each kit contains 30 tablets
• Each tablet contains 100mg of drug substance
• 10% yield loss during tablet manufacturing

Base Kit Demand:     100 patients × 10 visits × 1 kit = 1,000 kits
Tablet Demand:       1,000 kits × 30 tablets = 30,000 tablets
Substance Demand:    30,000 tablets × 100mg = 3,000,000mg = 3kg
Yield-Adjusted:      3kg ÷ (1 - 0.10) = 3.33kg needed

Prognosis performs this calculation automatically across all treatment arms, kits, and trials.

Substance Analytics

The Analytics view aggregates requirements across your entire trial portfolio.

Trial-Level Breakdown

See how much substance is needed for each trial:

Overall Summary

See total requirements across all trials:

Using the Analytics

These projections help you:

• Plan procurement — Know how much API to order
• Schedule manufacturing — Align substance production with trial timelines
• Manage inventory — Track substance levels across products
• Budget planning — Estimate material costs

Best Practices

Accurate Input Data

The quality of your forecast depends on accurate inputs:

• Substance per unit — Verify with formulation specifications
• Yield loss — Use historical manufacturing data
• Trial linkages — Ensure all relevant trials are connected

Regular Updates

Keep your drug substance data current:

• Update when formulations change
• Adjust yield loss based on actual manufacturing performance
• Add new trials as they're created

Multi-Product Planning

For substances used in multiple products:

• Create each drug product separately
• Link each product to relevant trials
• The analytics will aggregate across all products

Portfolio View

Use the Analytics view to see substance requirements across your entire portfolio, not just individual trials. This helps with:

• Long-term procurement planning
• Capacity allocation
• Budget forecasting

Advanced Features

Yield Loss Adjustment

The yield-adjusted requirement accounts for manufacturing losses:

Adjusted Requirement = Base Requirement ÷ (1 - Yield Loss %)

This ensures you procure enough substance to produce the required quantity of drug product after accounting for typical manufacturing losses.

Multi-Trial Aggregation

When a drug substance is used across multiple trials:

1. Each trial's requirements are calculated independently
2. Requirements are summed across all linked trials
3. The total gives you a portfolio-level view

Timeline Considerations

While the current analytics provide total requirements, consider:

• When substance is needed (align with trial timelines)
• Substance shelf life (don't procure too early)
• Production lead times (work backwards from trial needs)

Next Steps

• How Substance Forecasting Works — Learn what drives your substance requirements and how to improve accuracy
• Advanced Features — Explore additional capabilities in Prognosis